A Phase 2 interventional study of Placebo capsules and Epeleuton in Non Alcoholic Fatty Liver Disease, sponsored by Afimmune. Completed at 16 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by Afimmune · Phase 2, Interventional, and Treatment
Among 122 studies in Non-alcoholic Fatty Liver Disease with a site in United Kingdom — 17 open to participants now, 27 under way, 9 of them phase 3. Non-alcoholic Fatty Liver Disease · United Kingdom.
Among the 122 studies in Non-alcoholic Fatty Liver Disease with a site in United Kingdom, this one is the 56th largest by enrollment of the 101 interventional ones that give a count, is one of 9 that started in 2016, is one of 38 in phase 2, and was the 36th registered.
1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.
Browse Non-alcoholic Fatty Liver Disease studies →17 of the 122 studies in Non-alcoholic Fatty Liver Disease with a site in United Kingdom are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United Kingdom, United States, Puerto Rico
Ages 18–75
Eli Lilly and Company · Sites in United Kingdom, United States, Argentina and 31 more countries
Ages 18+
University of Nottingham · Sites in United Kingdom
Ages 18+ · Healthy volunteers
University of Oxford · Sites in United Kingdom
Ages 18+ · Women only
Akero Therapeutics, Inc · Sites in United Kingdom, United States, Argentina and 20 more countries
Ages 18–80
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 220 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 125 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
122 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 41 · Phase 3 19 · Phase 4 4
First in 2008; this study’s year is marked. 9 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 96 is above the median of 60 across 1,177 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Median enrollment 104 across the 101 interventional studies, 153 across the 21 observational. Of the 86 that completed or were terminated, 44 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
68 of 122 have an industry lead sponsor. The 10 most frequent:
Afimmune is the lead sponsor of 5 studies on the registry; none are open to participants now.
Afimmune has 1 study filed under Non-alcoholic Fatty Liver Disease — fewer than ten, so there is no comparison to draw.
5 of the studies in Non-alcoholic Fatty Liver Disease with a site in United Kingdom that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07093346University of NottinghamThe Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) | 2027-03-31 |
| NCT04666402Manchester University NHS Foundation TrustIntegrated Diagnostics for Early Diagnosis of Liver Disease | 2027-03-31 |
| NCT06920316St. George's Hospital, LondonDigital Diet and Exercise Intervention to Reduce Liver Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) | 2027-05 |
| NCT06836609Regeneron PharmaceuticalsA Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH) | 2027-08-17 |
| NCT04227782University of OxfordMRI and Stable Isotope Tracer Studies for Detecting the Progression of Non-Alcoholic Steatohepatitis (NASH) | 2027-10-01 |
Add all 5 to your calendar (.ics) → With an account.
Among the 122 studies in Non-alcoholic Fatty Liver Disease with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this randomised, double-blind, placebo-controlled, parallel group study is to assess the safety and efficacy of orally administered Epeleuton capsules versus placebo in the treatment of adult patients with Non Alcoholic Fatty Liver Disease (NAFLD)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
Other: Placebo capsules
1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks
Drug: Epeleuton
2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
Drug: Epeleuton
Change in Serum ALT (Alanine Aminotransferase) From Baseline to Week 16
Change in serum ALT from baseline to Week 16 using ANCOVA.
Time frame: 16 Weeks
Change in Liver Stiffness Measurements by Transient Elastography From Baseline to Week 16
To evaluate change in liver stiffness measurements using Transient Elastography from baseline to Week 16 using FibroScan® 502 Touch model or equivalent.
Time frame: 16 Weeks
Number of Treatment Emergent Adverse Events (TEAEs) in Each Treatment Group Leading to Treatment Discontinuation
Subjects with at least 1 TEAE leading to treatment discontinuation
Time frame: 20 Weeks
Change in Serum ALT (Alanine Aminotransferase) From Baseline to Weeks 2, 4, 8 and 12
Change in serum ALT from baseline to weeks 2, 4, 8 and 12.
Time frame: 12 Weeks
Change in AST (Aspartate Aminotransferase) From Baseline to Weeks 2, 4, 8, 12 and 16
Change in serum AST from baseline to weeks 2, 4, 8, 12 and 16.
Time frame: 16 Weeks
Change in AST:ALT Ratio From Baseline to Weeks 2, 4, 8, 12 and 16
Change in AST: ALT ratio from baseline to weeks 2, 4, 8, 12 and 16.
Time frame: 16 Weeks
Change in FIB-4 Index From Baseline to Week 16
Change in FIB-4 Index from baseline to week 16. This index is based on age, platelet count, ALT level, and AST level and will be assessed at Baseline (Visit 2) and week 16 (Visit 10). FIB-4 was calculated using the following formula: FIB4 = (Age (years) x AST (U/L))/(Platelet count (10\^9/L) x √ALT (U/L)). A decrease in FIB-4 represents a positive outcome. A FIB-4 Index of \<1.45 indicates none to moderate fibrosis and an Index of \>3.25 indicates advanced fibrosis.
Time frame: 16 Weeks
Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) From Baseline to Week 16
Change in NAFLD fibrosis score (NFS) from baseline to week 16. The NFS is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. NFS was calculated using the following formula: NAFLD fibrosis score = -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 decrease in NFS score represents a positive outcome. An NFS score of \<-1.455 indicates no advanced fibrosis and a score of \>0.676 indicates liver fibrosis.
Time frame: 16 Weeks
Change in ELF (Enhanced Liver Fibrosis Score) From Baseline to Week 16
Change in ELF from baseline to week 16. Enhanced Liver Fibrosis score is an extracellular matrix marker set consisting of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP) and hyaluronic acid (HA). A decrease in ELF score represents a positive outcome. The ELF score was calculated for the instrument based on the following equation: ELF score = 2.494 + 0.846 In (CHA) + 0.735 In (CPIIINP) + 0.391 In (CTIMP-1). 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.
Time frame: 16 Weeks
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16
Change in HOMA-IR from baseline to weeks 2,4,8,12,16. Homeostatic model assessment for insulin resistance (HOMA-IR) was assessed as a measure of insulin resistance. HOMA-IR is calculated by multiplying fasting plasma insulin by fasting plasma glucose, then dividing by the constant 405. 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.
Time frame: 16 Weeks
Change in Adipo-IR (Adipose Tissue Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16.
Change in Adipo-IR from baseline to weeks 2, 4, 8, 12 and 16. Adipose tissue insulin resistance (Adipo-IR) was assessed as a measure of insulin resistance. Adipo- IR is calculated by multiplying fasting non-esterified fatty acids by fasting insulin. A decrease in Adipo-IR indicates a positive outcome.
Time frame: 16 Weeks
Change in Hepatic Fat Measured by CAP (Controlled Attenuation Parameter) From Baseline to Week 16.
Change in hepatic fat measured by CAP (controlled attenuation parameter) from baseline to week 16 using FibroScan® 502 Touch model or equivalent. CAP score is measured in decibels per meter (dB/m). A reduction in hepatic fat measured non-invasively by CAP indicates an improvement in hepatic steatosis. CAP scores range from 100 to 400dB/m. 0 to 237 dB/M indicates no hepatic steatosis, 238 to 260 dB/m indicates mild hepatic steatosis, 260 to 290 dB/m indicates moderate steatosis and a CAP score greater than 290 dB/m indicates severe steatosis.
Time frame: 16 Weeks
| Milestone | Placebo | 1000 mg Epeleuton | 2000mg Epeleuton |
|---|---|---|---|
| Started | 31 | 32 | 33 |
| Completed | 28 | 31 | 31 |
| Not completed | 3 | 1 | 2 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 2 |
Change in serum ALT from baseline to Week 16 using ANCOVA.
| U/L | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change in Serum ALT (Alanine Aminotransferase) From Baseline to Week 16 | -16.3 (-44.2 to 11.7) | -6.9 (-34.5 to 20.7) | -10.1 (-36.9 to 16.8) |
To evaluate change in liver stiffness measurements using Transient Elastography from baseline to Week 16 using FibroScan® 502 Touch model or equivalent.
| kPa | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change in Liver Stiffness Measurements by Transient Elastography From Baseline to Week 16 | -2.226 (-3.07 to -1.38) | -1.308 (-2.11 to -0.51) | -0.727 (-1.55 to 0.100) |
Subjects with at least 1 TEAE leading to treatment discontinuation
| TEAEs | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) in Each Treatment Group Leading to Treatment Discontinuation | 1 | 0 | 0 |
Change in serum ALT from baseline to weeks 2, 4, 8 and 12.
| U/L | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change from Baseline to Week 2 | -0.4 (-13.3 to 12.4) | -0.1 (-13.0 to 12.8) | -5.8 (-18.2 to 6.6) |
| Change from Baseline to Week 4 | -3.4 (-14.9 to 8.2) | 4.0 (-7.6 to 15.7) | -1.9 (-13.0 to 9.3) |
| Change from Baseline to Week 8 | -8.7 (-23.1 to 5.7) | -12.7 (-27.1 to 1.6) | -3.8 (-17.4 to 9.9) |
| Change from Baseline to Week 12 | -18.3 (-45.3 to 8.8) | -19.2 (-45.3 to 6.9) | -3.8 (-28.7 to 21.0) |
Change in serum AST from baseline to weeks 2, 4, 8, 12 and 16.
| U/L | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change from Baseline to Week 2 | -5.6 (-22.1 to 10.8) | -4.9 (-21.3 to 11.5) | 4.9 (-11.3 to 21.1) |
| Change from Baseline to Week 4 | -4.0 (-12.5 to 4.6) | -1.1 (-9.7 to 7.5) | 2.0 (-6.4 to 10.5) |
| Change from Baseline to Week 8 | -4.6 (-13.1 to 3.8) | -9.9 (-18.2 to -1.6) | -0.9 (-9.0 to 7.2) |
| Change from Baseline to Week 12 | -13.7 (-28.3 to 0.9) | -11.2 (-25.3 to 2.8) | -3.2 (-17.0 to 10.5) |
| Change from Baseline to Week 16 | -8.9 (-35.4 to 17.6) | 7.7 (-18.3 to 33.7) | -4.6 (-32.5 to 23.4) |
Change in AST: ALT ratio from baseline to weeks 2, 4, 8, 12 and 16.
| Ratio | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change from Baseline to Week 2 | 0.00 (-0.12 to 0.12) | -0.04 (-0.15 to 0.07) | 0.05 (-0.06 to 0.16) |
| Change from Baseline to Week 4 | 0.02 (-0.06 to 0.09) | -0.03 (-0.10 to 0.05) | 0.06 (-0.02 to 0.13) |
| Change from Baseline to Week 8 | 0.01 (-0.06 to 0.08) | 0.00 (-0.06 to 0.06) | 0.03 (-0.04 to 0.09) |
| Change from Baseline to Week 12 | 0.02 (-0.07 to 0.11) | 0.03 (-0.05 to 0.11) | 0.01 (-0.07 to 0.09) |
| Change from Baseline to Week 16 | 0.03 (-0.07 to 0.14) | 0.10 (0.01 to 0.19) | 0.02 (-0.08 to 0.13) |
Change in FIB-4 Index from baseline to week 16. This index is based on age, platelet count, ALT level, and AST level and will be assessed at Baseline (Visit 2) and week 16 (Visit 10). FIB-4 was calculated using the following formula: FIB4 = (Age (years) x AST (U/L))/(Platelet count (10\^9/L) x √ALT (U/L)). A decrease in FIB-4 represents a positive outcome. A FIB-4 Index of \<1.45 indicates none to moderate fibrosis and an Index of \>3.25 indicates advanced fibrosis.
| Scores on a scale | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change in FIB-4 Index From Baseline to Week 16 | -0.109 (-0.398 to 0.181) | 0.114 (-0.196 to 0.424) | -0.068 (-0.384 to 0.248) |
Change in NAFLD fibrosis score (NFS) from baseline to week 16. The NFS is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. NFS was calculated using the following formula: NAFLD fibrosis score = -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 decrease in NFS score represents a positive outcome. An NFS score of \<-1.455 indicates no advanced fibrosis and a score of \>0.676 indicates liver fibrosis.
| Scores on a scale | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) From Baseline to Week 16 | -0.0073 (-0.2653 to 0.2507) | 0.2250 (-0.0529 to 0.5028) | -0.0340 (-0.3149 to 0.2469) |
Change in ELF from baseline to week 16. Enhanced Liver Fibrosis score is an extracellular matrix marker set consisting of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP) and hyaluronic acid (HA). A decrease in ELF score represents a positive outcome. The ELF score was calculated for the instrument based on the following equation: ELF score = 2.494 + 0.846 In (CHA) + 0.735 In (CPIIINP) + 0.391 In (CTIMP-1). 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.
| Scores on a scale | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change in ELF (Enhanced Liver Fibrosis Score) From Baseline to Week 16 | 0.24 (-0.09 to 0.56) | 0.10 (-0.19 to 0.39) | 0.01 (-0.29 to 0.31) |
Change in HOMA-IR from baseline to weeks 2,4,8,12,16. Homeostatic model assessment for insulin resistance (HOMA-IR) was assessed as a measure of insulin resistance. HOMA-IR is calculated by multiplying fasting plasma insulin by fasting plasma glucose, then dividing by the constant 405. 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.
| HOMA-IR | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change from Baseline to Week 2 | 1.208 (-1.102 to 3.518) | 1.250 (-1.024 to 3.525) | -0.569 (-2.762 to 1.623) |
| Change from Baseline to Week 4 | 2.175 (-1.393 to 5.743) | -0.540 (-4.154 to 3.075) | 2.347 (-1.166 to 5.860) |
| Change from Baseline to Week 8 | 6.606 (0.563 to 12.649) | 1.817 (-4.280 to 7.913) | 4.283 (-1.707 to 10.273) |
| Change from Baseline to Week 12 | -0.045 (-1.769 to 1.680) | 0.00 (-1.677 to 1.678) | -0.258 (-1.858 to 1.343) |
| Change from Baseline to Week 16 | -0.393 (-1.310 to 0.524) | -0.326 (-1.234 to 0.582) | -2.037 (-2.912 to -1.162) |
Change in Adipo-IR from baseline to weeks 2, 4, 8, 12 and 16. Adipose tissue insulin resistance (Adipo-IR) was assessed as a measure of insulin resistance. Adipo- IR is calculated by multiplying fasting non-esterified fatty acids by fasting insulin. A decrease in Adipo-IR indicates a positive outcome.
| Adipo-IR | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change from Baseline to Week 2 | 9.69 (-6.05 to 25.42) | -5.55 (-21.08 to 9.97) | -10.80 (-25.66 to 4.06) |
| Change from Baseline to Week 4 | 24.88 (1.94 to 47.82) | 3.45 (-19.86 to 26.75) | 4.19 (-18.09 to 26.47) |
| Change from Baseline to Week 8 | 25.52 (5.86 to 45.18) | 10.40 (-9.28 to 30.07) | 6.63 (-11.79 to 25.05) |
| Change from Baseline to Week 12 | 4.20 (-12.46 to 20.86) | -6.28 (-22.88 to 10.32) | -20.66 (-36.35 to -4.97) |
| Change from Baseline to Week 16 | 3.66 (-12.54 to 19.86) | -10.68 (-26.80 to 5.43) | -21.07 (-36.44 to -5.69) |
Change in hepatic fat measured by CAP (controlled attenuation parameter) from baseline to week 16 using FibroScan® 502 Touch model or equivalent. CAP score is measured in decibels per meter (dB/m). A reduction in hepatic fat measured non-invasively by CAP indicates an improvement in hepatic steatosis. CAP scores range from 100 to 400dB/m. 0 to 237 dB/M indicates no hepatic steatosis, 238 to 260 dB/m indicates mild hepatic steatosis, 260 to 290 dB/m indicates moderate steatosis and a CAP score greater than 290 dB/m indicates severe steatosis.
| dB/m | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Change in Hepatic Fat Measured by CAP (Controlled Attenuation Parameter) From Baseline to Week 16. | -12.3 (-34.4 to 9.9) | -16.3 (-36.8 to 4.1) | -22.4 (-43.0 to -1.8) |
Collected over Up to 20 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/31 (0%) | 1/31 (3.2%) | 16/31 (51.6%) |
| 1000 mg Epeleuton | 0/32 (0%) | 0/32 (0%) | 20/32 (62.5%) |
| 2000 mg Epeleuton | 0/33 (0%) | 1/33 (3%) | 14/33 (42.4%) |
| Event | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| Pilonidal CystInfections and infestations | 1/31 | 0/32 | 0/33 |
| SchizophreniaPsychiatric disorders | 0/31 | 0/32 | 1/33 |
| Event | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton |
|---|---|---|---|
| HeadacheNervous system disorders | 1/31 | 5/32 | 2/33 |
| DiarrheaGastrointestinal disorders | 3/31 | 3/32 | 2/33 |
| Blood creatine phosphokinase increasedInvestigations | 3/31 | 3/32 | 0/33 |
| DizzinessNervous system disorders | 0/31 | 3/32 | 0/33 |
| FatigueGeneral disorders | 1/31 | 3/32 | 0/33 |
| DysgeusiaNervous system disorders | 0/31 | 0/32 | 3/33 |
| NauseaGastrointestinal disorders | 2/31 | 2/32 | 0/33 |
| VomitingGastrointestinal disorders | 2/31 | 1/32 | 0/33 |
| Abdominal pain upperGastrointestinal disorders | 0/31 | 2/32 | 1/33 |
| Upper respiratory tract infectionInfections and infestations | 1/31 | 2/32 | 2/33 |
The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.
| Age, Continuous(years) | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton | Total |
|---|---|---|---|---|
| Mean | 48.4 ± 11.67 | 50.8 ± 13.72 | 46.1 ± 11.92 | 48.4 ± 12.44 |
| Sex: Female, Male(Participants) | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton | Total |
|---|---|---|---|---|
| Female | 9 | 12 | 12 | 33 |
| Male | 22 | 20 | 21 | 63 |
| Race (NIH/OMB)(Participants) | Placebo | 1000 mg Epeleuton | 2000 mg Epeleuton | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 2 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 28 | 30 | 33 | 91 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2016 to primary completion in Jan 2019, 24 months.
Results were first posted in Apr 2022, 3 years 3 months after primary completion.
Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 24 months is close to that.
Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease →
Afimmune