A Phase 2 interventional study of GFT505 80mg and GFT505 120mg in Non-Alcoholic Steatohepatitis (NASH), sponsored by Genfit. Completed at 56 sites in 9 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Genfit · Phase 2, Interventional, and Treatment
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is considered as the most common form of chronic liver disease in adults in the United States, Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the adult population.
Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to hepatic steatosis associated with inflammation and liver cell injury upon microscopic examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Up to now, there is no effective drug which has clearly demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the resolution of NASH.
In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with the metabolic syndrome and type 2 Diabetes.
This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver biopsy assessments.
The study duration per patient will be 80 weeks. A screening period (from 4 to 16 weeks) will precede a 52-week double-blind treatment period and a 3 months follow-up period.
The study will be conducted in 270 patients (90 patients in the placebo arm, 90 patients in the GFT505 80mg arm, and 90 patients in the GFT505 120mg arm).
Enrollment will be performed in two phases: during the first phase, the patients will receive either GFT505 at a dose of 80 mg either the placebo. An independent expert committee will review the safety data when 45 patients receiving the dose at 80 mg will have been treated for 6 months. The committee approval will be necessary to start the second phase, while the patients will receive either GFT505 at a dose of 80 mg, or GFT505 at a dose of 120 mg or the placebo.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 275 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Genfit is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hard gelatin capsules dosed at 40mg, oral administration, 3 capsules per day before breakfast with a glass of water.
Drug: GFT505 80mg
Hard gelatin capsules dosed at 40mg, oral administration, 3 capsules per day before breakfast with a glass of water.
Drug: GFT505 120mg
hard gelatin capsules, oral administration, 3 capsules per day before breakfast with a glass of water.
Drug: Placebo
Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis)
Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis. Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as: * Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy * Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg the change from baseline to Week 52, in Non-alcoholic Fatty Liver Disease Activity Score (NAS score). NAS score is a composite score equal to the sum of the steatosis grade (0 to 3), lobular inflammation grade (0 to 3) and hepatocellular ballooning grade (0 to 2). The overall scale of the NAS is 0 to 8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points
To evaluate the number of participants with at least a 2 point decrease from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) after 52 weeks of daily administration of GFT505 80mg or 120mg. The NAS refers to the severity of ongoing liver injury as assessed by a liver biopsy and is used to assess the activity of the disease. It is based on the NASH CRN methodology for scoring the severity of steatosis (score of 0 to 3), inflammation (score of 0 to 3), and hepatocellular ballooning (score of 0 to 2), with a maximum score of 8. A total NAS score of five or greater correlates with the diagnosis of steatohepatitis. In table below for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 2 participants (out of 10 participants analysed with a baseline NAS at 3) had at Least 2 points decrease on their NAS after 52 weeks of daily administration of GFT505 80mg. It corresponds to 20% (2 out of 10).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in steatosis score of at least 1 point between baseline and Week 52. Steatosis is assessed by a liver biopsy and evaluated on a scale of 0 to 3 with higher scores indicating more severe steatosis. A score of 0 indicating a lower severity with low parenchymal involvement (\<5%), while a score of 3 is indicative of higher involvment/severity (\> 66%). In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease Steatosis Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in lobular inflammation score of at least 1 point between baseline and Week 52. Lobular inflammation is assessed by a liver biopsy and evaluated on a scale of 0 to 3. A score of 0 indicating the absence of inflammation loci, while a score of 3 is indicative of a higher degree of inflammation with more than 4 inflammation loci 200 x field. In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Lobular Inflammation Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in ballooning score of at least 1 point between baseline and Week 52. Ballooning is assessed by a liver biopsy and evaluated on a scale of 0 to 2 with higher scores indicating more severe ballooning (0: No ballooned cells, 1: Few \[rare but definite\] ballooned hepatocytes; 2: Many ballooned cells/prominent ballooning). In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 4 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Ballooning Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in the Stages of Fibrosis
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in stages of fibrosis (based on Non-Alcoholic Steatohepatitis Clinical Research Network \[NASH CRN\] scoring). Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in liver enzymes.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in aspartate transaminase/alanine aminotransferase ratio
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK 18-M65 (non-invasive markers of fibrosis and steatosis).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK18 M30
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK18 M30 (non-invasive markers of fibrosis and steatosis). Participants with missing data for CK18 M30 at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Adiponectin
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in adiponectin (non-invasive markers of fibrosis and steatosis).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Ferritin
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in ferritin (non-invasive markers of fibrosis and steatosis). Participants with missing data for Ferritin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: FG19 and FG21
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in FG19 and FG21 (non-invasive markers of fibrosis and steatosis).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Alpha2 Macroglobulin
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in alpha2 macroglobulin (a non-invasive marker of fibrosis and steatosis). Participants with missing data for Alpha2 Macroglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1)
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in hyaluronic acid, N-terminal pro-peptide of collagen type III (PIIINP), and tissue inhibitor of matrix metalloprotease-1 (TIMP-1) (non-invasive markers of fibrosis and steatosis).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrotest
Fibrotest combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT with adjustment for age and gender. Fibrotest is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e\^-z). Calculated score range from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Fibrotest calculated in 81 participants is -0.06 with a standard deviation of 0.08.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Steatotest
SteatoTest combines α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, and ALT, adjusted for patient's age, sex, weight, and height. Patented formula. Calculated score range from 0 (no steatosis) to 1 (severe steatosis) In below table for "Steatotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Steatotest calculated in 81 participants is -0.09 with a standard deviation of 0.11.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score
Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. Score is calculated using the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m\^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10\^9/l) - 0.66 × albumin (g/dl). A score of \<-1.455 indicates no advanced fibrosis and a score of \>0.676 indicates liver fibrosis. In below table for "Angulo index" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Angulo index calculated in 82 participants is 0.06 with a standard deviation of 0.53.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Enhanced Liver Fibrosis (ELF)
Enhanced Liver Fibrosis (ELF) combines measurements of tissue inhibitor of metalloprotein-ases-1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid (HA) . The ELF score is calculated as : 2.278 + 0.851 ln (HA) + 0.751 ln (PIIINP) + 0.394 ln (TIMP-1). ELF score range from An ELF score of less than 7.7 indicates no fibrosis. An ELF score greater than or equal to 9.8 indicates severe fibrosis. An ELF score of 11.3 or greater indicates cirrhosis. A decrease in ELF score represents a positive outcome In below table for "Enhanced Liver Fibrosis" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Enhanced Liver Fibrosis calculated in 81 analysed participants is -0.01 with a standard deviation of 0.54.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fatty Liver Index (FLI)
The Fatty Liver Index (FLI) combines triglycerides, BMI, GGT and Waist circumference. FLI is calculated as : (e0.953×loge\[triglycerides\]+0.139× Body Mass Index\[BMI\]+0.718×loge Gamma- Glutamyl Transferase \[GGT\]+0.053×waistcircumference-15.745)/ (1 +e0.953×loge\[triglycerides\]+0.139×BMI+0.718×loge \[GGT\]+0.053×waistcircumference-15.745) × 100. Calculated index range from 0 to 100. FLI score below 30 indicate absence of Fatty Liver and FLI Score of 60 and above indicates presence of Fatty Liver. In below table for "Fatty Liver Index" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fatty Liver Index calculated in 82 analysed participants is -7.94 with a standard deviation of 11.74.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrometer
Fibrometer combines Platelets, AST, ALT, ferritin, glucose (fasting plasma), Weight and gender. Patented formula. Score ranges from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrometer" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fibrometer calculated in 81 analysed participants is 0.04 with a standard deviation of 0.23.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Total Bilirubin and Conjugated Bilirubin
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in total bilirubin and conjugated bilirubin (non-invasive markers of fibrosis and steatosis).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Prothrombin Ratio
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in prothrombin ratio (non-invasive marker of fibrosis and steatosis). The Prothrombin ratio is the ratio of a participants measured prothrombin time (in seconds) to the normal laboratory reference prothrombin time. Participants with missing data for Prothrombin ratio at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: International Normalized Ratio (INR)
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in international normalized ratio (INR; non-invasive marker of fibrosis and steatosis). Participants with missing data for International Normalized Ratio (INR) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile)
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in lipid parameters (used to assess cardiovascular risk)
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in secondary outcomes related to biochemistry
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Insulin Resistance: Leptin
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in leptin (to assess insulin resistance).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Insulin Resistance: Insulin
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in insulin (to assess insulin resistance). Participants with missing data for Insulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Insulin Resistance: C Peptide
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in C peptide (to assess insulin resistance). Participants with missing data for C Peptide at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Insulin Resistance: Homeostatic Model Assessment-insulin Resistance (HOMA-IR)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in homeostatic model assessment-insulin resistance (HOMA-IR; to assess insulin resistance). The HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) x fasting plasma glucose (mmol/l) / 22.5 A decrease in HOMA-IR indicates a positive outcome. HOMA-IR values of greater than 1.9 indicates early insulin resistance and levels above 2.9 indicate significant insulin resistance. Participants with missing data for HOMA-IR at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Insulin Resistance: Free Fatty Acids (FFA)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in free fatty acids (FFA; to assess insulin resistance). Participants with missing data for Free Fatty Acids (FFA) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Insulin Resistance: Plasma Glucose
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in plasma glucose (to assess insulin resistance). Participants with missing data for Plasma Glucose at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Insulin Resistance: Glycosylated Haemoglobin A1c (HbA1c)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in glycosylated haemoglobin A1c (HbA1c; to assess insulin resistance). Participants with missing data for Haemoglobin A1c (HbA1c) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Insulin Resistance: Fructosamine
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in Fructosamine (to assess insulin resistance).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Inflammatory Markers: Fibrinogen and Haptoglobin
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in fibrinogen and haptoglobin (inflammatory markers).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Inflammatory Markers: Tumour Necrosis Factor Alpha and Interleukine 6
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in tumour necrosis factor alpha and interleukine 6 (inflammatory markers).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Inflammatory Markers: Plasminogen Activator Inhibitor 1 (PAI-1)
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in plasminogen activator inhibitor 1 (PAI-1; inflammatory marker). Participants with missing data for Plasminogen Activator Inhibitor 1 (PAI-1) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Inflammatory Markers: C-Reactive Protein (CRP)
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in C-Reactive Protein (CRP; inflammatory marker).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Safety Markers: Creatinine (Renal Function Parameter)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine (safety markers; renal function parameter).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Safety Markers: Creatinine Clearance (Renal Function Parameter)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine clearance (safety marker; renal function parameter).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Safety Markers: Uric Acid (Renal Function Parameter)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in uric acid (safety marker; renal function parameter).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Safety Markers: Blood Urea Nitrogen (BUN; Renal Function Parameter)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in blood urea nitrogen (BUN; safety marker; renal function parameter).
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Safety Markers: Cystatin C (Renal Function Parameter)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in cystatin C (safety marker; renal function parameter). Participants with missing data for Cystatin C at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Safety Markers: Beta2-microglobulin (Renal Function Parameter)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in beta2-microglobulin (safety marker; renal function parameter). Participants with missing data for Beta2-microglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Safety Markers: N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP; Cardiac Function Parameter)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in N-terminal prohormone of brain natriuretic peptide (NT-proBNP; safety marker; cardiac function parameter). Participants with missing data for NT-proBNP at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Safety Markers: Troponin T (Cardiac Function Parameter)
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in troponin T (safety marker; cardiac function parameter). Participants with missing data for Troponin T at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Changes From Baseline to Week 52 in Body Weight
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in body weight.
Time frame: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
Recruitment for the GFT505-212-7 study began in September 2012. This was a phase IIb, double-blind, randomized, placebo-controlled study conducted in three parallel groups: placebo, GFT505 80mg and GFT505 120mg (after DSMB review of 6 month safety data of the 80mg dose on at least 50% of participants) once daily for 52 weeks.
| Milestone | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Started | 93 | 90 | 92 |
| Randomized | 93 | 90 | 92 |
| Randomised and received treatment (full analysis set and safety set) | 93 | 89 | 92 |
| Efficacy evaluable set | 82 | 78 | 77 |
| Completed | 84 | 79 | 78 |
| Not completed | 9 | 11 | 14 |
| Withdrew: Adverse event | 6 | 7 | 4 |
| Withdrew: Withdrawal by subject | 1 | 3 | 7 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 | 1 |
| Withdrew: Non-compliance | 1 | 0 | 1 |
| Withdrew: Randomized and not treated | 0 | 1 | 0 |
| Milestone | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Started | 84 | 79 | 78 |
| Completed | 83 | 76 | 77 |
| Not completed | 1 | 3 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 2 | 1 |
Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis. Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as: * Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy * Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy
| Participants | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Efficacy evaluable set — Responders | 21 | 19 | 16 |
| Efficacy evaluable set — Non-responders | 61 | 59 | 61 |
| Full analysis set — Responders | 21 | 19 | 16 |
| Full analysis set — Non-responders | 72 | 70 | 76 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg the change from baseline to Week 52, in Non-alcoholic Fatty Liver Disease Activity Score (NAS score). NAS score is a composite score equal to the sum of the steatosis grade (0 to 3), lobular inflammation grade (0 to 3) and hepatocellular ballooning grade (0 to 2). The overall scale of the NAS is 0 to 8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.
| NAS score | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score | -0.65 ± 1.33 | -0.64 ± 1.68 | -0.45 ± 1.34 |
To evaluate the number of participants with at least a 2 point decrease from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) after 52 weeks of daily administration of GFT505 80mg or 120mg. The NAS refers to the severity of ongoing liver injury as assessed by a liver biopsy and is used to assess the activity of the disease. It is based on the NASH CRN methodology for scoring the severity of steatosis (score of 0 to 3), inflammation (score of 0 to 3), and hepatocellular ballooning (score of 0 to 2), with a maximum score of 8. A total NAS score of five or greater correlates with the diagnosis of steatohepatitis. In table below for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 2 participants (out of 10 participants analysed with a baseline NAS at 3) had at Least 2 points decrease on their NAS after 52 weeks of daily administration of GFT505 80mg. It corresponds to 20% (2 out of 10).
| Participants | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Mild (Non-alcoholic Fatty Liver Disease Activity Score 3) | 2 | 2 | 5 |
| Moderate (Non-alcoholic Fatty Liver Disease Activity Score 4-5) | 11 | 12 | 9 |
| Severe (Non-alcoholic Fatty Liver Disease Activity Score 6-8) | 8 | 12 | 7 |
| Total | 21 | 26 | 21 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in steatosis score of at least 1 point between baseline and Week 52. Steatosis is assessed by a liver biopsy and evaluated on a scale of 0 to 3 with higher scores indicating more severe steatosis. A score of 0 indicating a lower severity with low parenchymal involvement (\<5%), while a score of 3 is indicative of higher involvment/severity (\> 66%). In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease Steatosis Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).
| Participants | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Mild (Non-Alcoholic Fatty Liver Disease Activity Score 3) | 1 | 1 | 0 |
| Moderate (Non-Alcoholic Fatty Liver Disease Activity Score 4-5) | 13 | 10 | 12 |
| Severe (Non-Alcoholic Fatty Liver Disease Activity Score 6-8) | 3 | 10 | 3 |
| Total | 17 | 21 | 15 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in lobular inflammation score of at least 1 point between baseline and Week 52. Lobular inflammation is assessed by a liver biopsy and evaluated on a scale of 0 to 3. A score of 0 indicating the absence of inflammation loci, while a score of 3 is indicative of a higher degree of inflammation with more than 4 inflammation loci 200 x field. In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Lobular Inflammation Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).
| Participants | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Mild (Non-Alcoholic Fatty Liver Disease Activity Score 3) | 1 | 2 | 7 |
| Moderate (Non-Alcoholic Fatty Liver Disease Activity Score 4-5) | 10 | 11 | 8 |
| Severe (Non-Alcoholic Fatty Liver Disease Activity Score 6-8) | 14 | 16 | 12 |
| Total | 25 | 29 | 27 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in ballooning score of at least 1 point between baseline and Week 52. Ballooning is assessed by a liver biopsy and evaluated on a scale of 0 to 2 with higher scores indicating more severe ballooning (0: No ballooned cells, 1: Few \[rare but definite\] ballooned hepatocytes; 2: Many ballooned cells/prominent ballooning). In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 4 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Ballooning Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).
| Participants | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Mild (Non-Alcoholic Fatty Liver Disease Activity Score 3) | 4 | 3 | 6 |
| Moderate (Non-Alcoholic Fatty Liver Disease Activity Score 4-5) | 17 | 15 | 13 |
| Severe (Non-Alcoholic Fatty Liver Disease Activity Score 6-8) | 10 | 12 | 5 |
| Total | 31 | 30 | 24 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in stages of fibrosis (based on Non-Alcoholic Steatohepatitis Clinical Research Network \[NASH CRN\] scoring). Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.
| Change in fibrosis score | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in the Stages of Fibrosis | -0.23 ± 0.84 | -0.06 ± 0.96 | -0.23 ± 0.90 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in liver enzymes.
| U/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Gamma-glutamyl transferase | -24.32 ± 36.39 | -20.59 ± 40.45 | 6.22 ± 50.64 |
| Aspartate transaminase | 1.88 ± 27.76 | -1.37 ± 24.74 | -1.32 ± 16.63 |
| Alanine aminotransferase | -7.02 ± 36.21 | -12.54 ± 44.72 | -3.26 ± 24.67 |
| Alkaline phosphatases | -18.82 ± 13.23 | -20.44 ± 16.47 | 3.44 ± 13.16 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in aspartate transaminase/alanine aminotransferase ratio
| ratio | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio | 0.15 ± 0.21 | 0.20 ± 0.25 | 0.01 ± 0.25 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK 18-M65 (non-invasive markers of fibrosis and steatosis).
| U/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65 | 104.4 ± 804.96 | -185.01 ± 658.14 | -45.53 ± 437.21 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK18 M30 (non-invasive markers of fibrosis and steatosis). Participants with missing data for CK18 M30 at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| pmol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK18 M30 | -28.08 ± 574.50 | -66.40 ± 432.02 | -51.39 ± 349.64 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in adiponectin (non-invasive markers of fibrosis and steatosis).
| μg/mL | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Adiponectin | 4.98 ± 20.25 | 1.90 ± 8.34 | 2.54 ± 9.48 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in ferritin (non-invasive markers of fibrosis and steatosis). Participants with missing data for Ferritin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| μg/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Ferritin | -23.52 ± 145.61 | -19.68 ± 81.91 | -19.26 ± 122.57 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in FG19 and FG21 (non-invasive markers of fibrosis and steatosis).
| pg/mL | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| FG19 | -27.25 ± 94.19 | -26.03 ± 91.59 | 11.64 ± 87.10 |
| FG21 | 258.74 ± 1138.36 | 319.68 ± 433.63 | 73.05 ± 360.41 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in alpha2 macroglobulin (a non-invasive marker of fibrosis and steatosis). Participants with missing data for Alpha2 Macroglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| g/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Alpha2 Macroglobulin | -0.14 ± 0.29 | -0.26 ± 0.36 | 0.01 ± 0.28 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in hyaluronic acid, N-terminal pro-peptide of collagen type III (PIIINP), and tissue inhibitor of matrix metalloprotease-1 (TIMP-1) (non-invasive markers of fibrosis and steatosis).
| ng/mL | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Hyaluronic acid | 26.12 ± 230.97 | 12.14 ± 48.04 | 12.49 ± 48.68 |
| PIIINP | -0.50 ± 3.43 | -0.57 ± 3.75 | 0.29 ± 4.87 |
| TIMP-1 | 15.21 ± 35.38 | -6.32 ± 39.75 | 9.08 ± 49.54 |
Fibrotest combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT with adjustment for age and gender. Fibrotest is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e\^-z). Calculated score range from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Fibrotest calculated in 81 participants is -0.06 with a standard deviation of 0.08.
| score on a scale | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrotest | -0.06 ± 0.08 | -0.07 ± 0.09 | -0.01 ± 0.10 |
SteatoTest combines α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, and ALT, adjusted for patient's age, sex, weight, and height. Patented formula. Calculated score range from 0 (no steatosis) to 1 (severe steatosis) In below table for "Steatotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Steatotest calculated in 81 participants is -0.09 with a standard deviation of 0.11.
| score on a scale | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Steatotest | -0.09 ± 0.11 | -0.08 ± 0.15 | 0.03 ± 0.11 |
Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. Score is calculated using the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m\^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10\^9/l) - 0.66 × albumin (g/dl). A score of \<-1.455 indicates no advanced fibrosis and a score of \>0.676 indicates liver fibrosis. In below table for "Angulo index" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Angulo index calculated in 82 participants is 0.06 with a standard deviation of 0.53.
| score on a scale | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score | 0.06 ± 0.53 | -0.26 ± 0.57 | -0.01 ± 0.51 |
Enhanced Liver Fibrosis (ELF) combines measurements of tissue inhibitor of metalloprotein-ases-1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid (HA) . The ELF score is calculated as : 2.278 + 0.851 ln (HA) + 0.751 ln (PIIINP) + 0.394 ln (TIMP-1). ELF score range from An ELF score of less than 7.7 indicates no fibrosis. An ELF score greater than or equal to 9.8 indicates severe fibrosis. An ELF score of 11.3 or greater indicates cirrhosis. A decrease in ELF score represents a positive outcome In below table for "Enhanced Liver Fibrosis" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Enhanced Liver Fibrosis calculated in 81 analysed participants is -0.01 with a standard deviation of 0.54.
| score on a scale | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Enhanced Liver Fibrosis (ELF) | -0.01 ± 0.54 | -0.01 ± 0.64 | 0.08 ± 0.70 |
The Fatty Liver Index (FLI) combines triglycerides, BMI, GGT and Waist circumference. FLI is calculated as : (e0.953×loge\[triglycerides\]+0.139× Body Mass Index\[BMI\]+0.718×loge Gamma- Glutamyl Transferase \[GGT\]+0.053×waistcircumference-15.745)/ (1 +e0.953×loge\[triglycerides\]+0.139×BMI+0.718×loge \[GGT\]+0.053×waistcircumference-15.745) × 100. Calculated index range from 0 to 100. FLI score below 30 indicate absence of Fatty Liver and FLI Score of 60 and above indicates presence of Fatty Liver. In below table for "Fatty Liver Index" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fatty Liver Index calculated in 82 analysed participants is -7.94 with a standard deviation of 11.74.
| score on a scale | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fatty Liver Index (FLI) | -7.94 ± 11.74 | -7.81 ± 14.29 | 1.34 ± 11.65 |
Fibrometer combines Platelets, AST, ALT, ferritin, glucose (fasting plasma), Weight and gender. Patented formula. Score ranges from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrometer" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fibrometer calculated in 81 analysed participants is 0.04 with a standard deviation of 0.23.
| score on a scale | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrometer | 0.04 ± 0.23 | 0 ± 0.20 | 0.02 ± 0.22 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in total bilirubin and conjugated bilirubin (non-invasive markers of fibrosis and steatosis).
| umol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Total bilirubin | -1.53 ± 3.66 | -1.38 ± 4.85 | -1.46 ± 3.77 |
| Conjugated bilirubin | -0.35 ± 1.26 | -0.15 ± 1.24 | -0.26 ± 1.05 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in prothrombin ratio (non-invasive marker of fibrosis and steatosis). The Prothrombin ratio is the ratio of a participants measured prothrombin time (in seconds) to the normal laboratory reference prothrombin time. Participants with missing data for Prothrombin ratio at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| ratio | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Prothrombin Ratio | -3.85 ± 11.57 | 1.29 ± 10.03 | 0.51 ± 14.28 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in international normalized ratio (INR; non-invasive marker of fibrosis and steatosis). Participants with missing data for International Normalized Ratio (INR) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| ratio | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: International Normalized Ratio (INR) | 0.03 ± 0.09 | -0.01 ± 0.08 | 0.03 ± 0.39 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in lipid parameters (used to assess cardiovascular risk)
| mmol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Triglycerides | -0.33 ± 0.76 | -0.48 ± 0.90 | 0.16 ± 1.12 |
| Cholesterol | -0.42 ± 0.78 | -0.42 ± 0.72 | 0.02 ± 0.66 |
| Non-high Density Lipoproteins Cholesterol | -0.45 ± 0.79 | -0.47 ± 0.71 | 0.07 ± 0.67 |
| High Density Lipoproteins Cholesterol | 0.02 ± 0.17 | 0.06 ± 0.23 | -0.06 ± 0.21 |
| Very Low Density Lipoproteins Cholesterol | -0.17 ± 0.28 | -0.17 ± 0.32 | 0.05 ± 0.23 |
| Low Density Lipoproteins Cholesterol | -0.27 ± 0.70 | -0.25 ± 0.61 | -0.01 ± 0.51 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in secondary outcomes related to biochemistry
| mg/dL | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Apo A1 | 1.63 ± 15.59 | 2.85 ± 20.42 | -3.90 ± 16.53 |
| Apo B | -12.80 ± 20.87 | -8.42 ± 16.03 | 0.94 ± 14.29 |
| Apo AII | -0.15 ± 6.63 | 4.25 ± 4.36 | -3.36 ± 4.82 |
| Apo CIII | -1.79 ± 3.91 | -0.69 ± 3.42 | 0.77 ± 4.30 |
| Apo CIII/B | -1.44 ± 2.98 | -0.65 ± 2.98 | 0.53 ± 3.05 |
| Apo CIII/nonB | -0.35 ± 1.79 | -0.04 ± 0.76 | 0.24 ± 2.53 |
| Small dense Low Density Lipoproteins | -2.09 ± 11.02 | -2.62 ± 6.08 | 0.60 ± 7.52 |
| Lp(a) | -0.57 ± 12.24 | -0.91 ± 13.75 | 0.80 ± 4.46 |
| Apo E | -1.72 ± 2.75 | -1.38 ± 2.99 | -0.29 ± 3.67 |
| Apo E/B | -1.43 ± 2.43 | -1.48 ± 2.64 | -0.21 ± 2.59 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in leptin (to assess insulin resistance).
| ng/mL | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Insulin Resistance: Leptin | -0.21 ± 9.55 | 3.51 ± 10.67 | 3.01 ± 8.08 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in insulin (to assess insulin resistance). Participants with missing data for Insulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| pmol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Insulin Resistance: Insulin | -33.88 ± 189.64 | -26.12 ± 111.76 | 8.92 ± 112.26 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in C peptide (to assess insulin resistance). Participants with missing data for C Peptide at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| nmol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Insulin Resistance: C Peptide | -0.17 ± 0.55 | -0.03 ± 0.48 | 0.12 ± 0.58 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in homeostatic model assessment-insulin resistance (HOMA-IR; to assess insulin resistance). The HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) x fasting plasma glucose (mmol/l) / 22.5 A decrease in HOMA-IR indicates a positive outcome. HOMA-IR values of greater than 1.9 indicates early insulin resistance and levels above 2.9 indicate significant insulin resistance. Participants with missing data for HOMA-IR at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| HOMA-IR score | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Insulin Resistance: Homeostatic Model Assessment-insulin Resistance (HOMA-IR) | -1.10 ± 10.76 | -1 ± 6.86 | 1.01 ± 4.96 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in free fatty acids (FFA; to assess insulin resistance). Participants with missing data for Free Fatty Acids (FFA) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| mmol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Insulin Resistance: Free Fatty Acids (FFA) | -0.04 ± 0.25 | -0.04 ± 0.24 | 0.05 ± 0.26 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in plasma glucose (to assess insulin resistance). Participants with missing data for Plasma Glucose at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| mmol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Insulin Resistance: Plasma Glucose | 0.17 ± 1.23 | 0.22 ± 1.70 | 0.67 ± 1.95 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in glycosylated haemoglobin A1c (HbA1c; to assess insulin resistance). Participants with missing data for Haemoglobin A1c (HbA1c) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| percentage of HbA1c | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Insulin Resistance: Glycosylated Haemoglobin A1c (HbA1c) | 0.22 ± 0.56 | 0.03 ± 0.70 | 0.25 ± 0.69 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in Fructosamine (to assess insulin resistance).
| umol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Insulin Resistance: Fructosamine | 16.27 ± 27.53 | -8.24 ± 28.21 | 11.29 ± 28.62 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in fibrinogen and haptoglobin (inflammatory markers).
| g/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Fibrinogen | -0.37 ± 0.70 | -0.37 ± 0.79 | -0.05 ± 0.66 |
| Haptoglobin | -0.19 ± 0.32 | -0.20 ± 0.40 | 0.09 ± 0.35 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in tumour necrosis factor alpha and interleukine 6 (inflammatory markers).
| pg/mL | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Tumour Necrosis Factor alpha | 1.37 ± 6.14 | -2.45 ± 38.58 | 0.19 ± 10.46 |
| Interleukine 6 | 0.37 ± 4.20 | -1.14 ± 10.33 | -0.06 ± 1.37 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in plasminogen activator inhibitor 1 (PAI-1; inflammatory marker). Participants with missing data for Plasminogen Activator Inhibitor 1 (PAI-1) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow
| ng/mL | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Inflammatory Markers: Plasminogen Activator Inhibitor 1 (PAI-1) | -0.51 ± 3.51 | 0.21 ± 4.28 | -0.14 ± 4.74 |
To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in C-Reactive Protein (CRP; inflammatory marker).
| Log (mg/L) | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Inflammatory Markers: C-Reactive Protein (CRP) | -0.04 ± 0.72 | -0.05 ± 0.81 | 0.20 ± 0.74 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine (safety markers; renal function parameter).
| μmol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Safety Markers: Creatinine (Renal Function Parameter) | 2.03 ± 7.89 | 5.61 ± 8.18 | 1.27 ± 7.85 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine clearance (safety marker; renal function parameter).
| mL/min | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Safety Markers: Creatinine Clearance (Renal Function Parameter) | -0.06 ± 0.94 | -0.56 ± 2.22 | -0.09 ± 0.62 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in uric acid (safety marker; renal function parameter).
| mmol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Safety Markers: Uric Acid (Renal Function Parameter) | 0 ± 0.06 | 0.01 ± 0.05 | -0.01 ± 0.06 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in blood urea nitrogen (BUN; safety marker; renal function parameter).
| mmol urea/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Safety Markers: Blood Urea Nitrogen (BUN; Renal Function Parameter) | 0.61 ± 1.28 | 0.67 ± 1.22 | -0.17 ± 1.14 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in cystatin C (safety marker; renal function parameter). Participants with missing data for Cystatin C at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| mg/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Safety Markers: Cystatin C (Renal Function Parameter) | 0.05 ± 0.10 | 0.04 ± 0.22 | 0.04 ± 0.13 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in beta2-microglobulin (safety marker; renal function parameter). Participants with missing data for Beta2-microglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| μg/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Safety Markers: Beta2-microglobulin (Renal Function Parameter) | -22.26 ± 326.42 | 0.11 ± 466.43 | -83.48 ± 279.31 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in N-terminal prohormone of brain natriuretic peptide (NT-proBNP; safety marker; cardiac function parameter). Participants with missing data for NT-proBNP at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| pmol/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Safety Markers: N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP; Cardiac Function Parameter) | 1.54 ± 4.16 | 0.38 ± 4.81 | -1.24 ± 5.35 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in troponin T (safety marker; cardiac function parameter). Participants with missing data for Troponin T at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.
| μg/L | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Safety Markers: Troponin T (Cardiac Function Parameter) | 0 ± 0 | 0 ± 0 | 0 ± 0 |
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in body weight.
| kg | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Changes From Baseline to Week 52 in Body Weight | 0.11 ± 3.61 | -0.69 ± 4.09 | -0.04 ± 3.40 |
Collected over Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks.. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GFT505 80mg | 0/93 (0%) | 12/93 (12.9%) | 85/93 (91.4%) |
| GFT505 120mg | 0/89 (0%) | 14/89 (15.7%) | 86/89 (96.6%) |
| Placebo | 0/92 (0%) | 9/92 (9.8%) | 85/92 (92.4%) |
| Event | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| Pancreatitis AcuteGastrointestinal disorders | 0/93 | 2/89 | 0/92 |
| VertigoEar and labyrinth disorders | 0/93 | 1/89 | 0/92 |
| Non-cardiac chest painGeneral disorders | 0/93 | 1/89 | 0/92 |
| SepsisInfections and infestations | 0/93 | 1/89 | 0/92 |
| Ankle fractureInjury, poisoning and procedural complications | 0/93 | 1/89 | 0/92 |
| OverdoseInjury, poisoning and procedural complications | 0/93 | 1/89 | 0/92 |
| Diabetes mellitusMetabolism and nutrition disorders | 0/93 | 1/89 | 0/92 |
| Diabetes ketoacidosisMetabolism and nutrition disorders | 0/93 | 1/89 | 0/92 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 0/93 | 1/89 | 0/92 |
| Parathyroid tumour benignNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/93 | 1/89 | 0/92 |
| Event | GFT505 80mg | GFT505 120mg | Placebo |
|---|---|---|---|
| NauseaGastrointestinal disorders | 18/93 | 17/89 | 14/92 |
| HeadacheNervous system disorders | 16/93 | 12/89 | 15/92 |
| FatigueGeneral disorders | 13/93 | 12/89 | 14/92 |
| DiarrhoeaGastrointestinal disorders | 14/93 | 9/89 | 6/92 |
| Abdominal pain upperGastrointestinal disorders | 12/93 | 9/89 | 13/92 |
| LeukocyturiaRenal and urinary disorders | 10/93 | 8/89 | 12/92 |
| Abdominal painGastrointestinal disorders | 9/93 | 11/89 | 11/92 |
| Procedural painInjury, poisoning and procedural complications | 6/93 | 11/89 | 10/92 |
| BronchitisInfections and infestations | 10/93 | 6/89 | 8/92 |
| InfluenzaInfections and infestations | 10/93 | 3/89 | 5/92 |
| Age, Continuous(years) | GFT505 80mg | GFT505 120mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 53.26 ± 11.02 | 52.88 ± 11.63 | 52.88 ± 11.99 | 53.01 ± 11.51 |
| Sex: Female, Male(Participants) | GFT505 80mg | GFT505 120mg | Placebo | Total |
|---|---|---|---|---|
| Female | 44 | 42 | 37 | 123 |
| Male | 49 | 47 | 55 | 151 |
| Race/Ethnicity, Customized(Participants) | GFT505 80mg | GFT505 120mg | Placebo | Total |
|---|---|---|---|---|
| Race — Caucasian | 88 | 71 | 85 | 244 |
| Race — Black | 2 | 5 | 3 | 10 |
| Race — Asian | 0 | 6 | 1 | 7 |
| Race — Other | 3 | 7 | 3 | 13 |
| Body Mass Index (BMI)(kg/m^2) | GFT505 80mg | GFT505 120mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 31.80 ± 5.20 | 31.04 ± 4.39 | 30.91 ± 4.15 | 31.25 ± 4.61 |
| Type 2 diabetes(participants) | GFT505 80mg | GFT505 120mg | Placebo | Total |
|---|---|---|---|---|
| Type 2 diabetes (Yes) | 37 | 37 | 33 | 107 |
| Type 2 diabetes (No) | 56 | 52 | 59 | 167 |
| Height(cm) | GFT505 80mg | GFT505 120mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 167.77 ± 9.30 | 170.21 ± 10.69 | 169.21 ± 10.23 | 169.05 ± 10.09 |
| Weight(kg) | GFT505 80mg | GFT505 120mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 89.62 ± 17.76 | 90.15 ± 15.57 | 88.72 ± 15.79 | 89.49 ± 16.36 |
| Waist Circumference(cm) | GFT505 80mg | GFT505 120mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 106.41 ± 13.09 | 106.26 ± 10.28 | 104.68 ± 10.52 | 105.78 ± 11.37 |
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Genfit