TerminatedNCT03551522Updated Sep 15, 2022Results posted

A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

A Phase 2 interventional study of Seladelpar and Placebos in NASH - Nonalcoholic Steatohepatitis, sponsored by Gilead Sciences. Terminated at 14 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-15.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Why this study was terminated

unexpected histological findings

Phase: Phase 2
Study type: Interventional
Enrollment: 181
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH)

OLE phase was not analyzed due to the early termination of the study

Read the detailed description

Primary Objectives

To evaluate the effect of seladelpar on hepatic fat fraction, as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12 in the DB phase
To evaluate the safety and tolerability of seladelpar in the DB and OLE phases

Secondary Objectives

To evaluate the effect of seladelpar on MRI- PDFF at Week 26 and Week 52 in the DB phase
To evaluate the effect of seladelpar on histological improvement of nonalcoholic fatty liver disease activity score (NAS) at Week 52 in the DB phase
To evaluate the effect of seladelpar on histological improvement of fibrosis at Week 52 in the DB phase
To evaluate the effect of seladelpar on metabolic biochemical markers and biochemical markers of inflammation in the DB and OLE phases

Conditions studied

NASH - Nonalcoholic Steatohepatitis

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In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 181 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

DB Inclusion Criteria:

Must be able to provide written informed consent (signed and dated) and any authorizations required by local law
18 to 75 years old (inclusive)
Histological evidence of definite NASH on a liver biopsy (obtained during the screening period or historical liver biopsy obtained no more than 90 days prior to the initial screening visit)
NAS of 4 points or greater with a score of at least 1 point in each component (steatosis, lobular inflammation, and ballooning)
Fibrosis stage 1, 2, or 3 on liver biopsy
MRI-PDFF ≥ 10%
Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 30 days after the last dose of study drug. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose of study drug.

DB Exclusion Criteria:

Significant alcohol consumption, defined as more than 2 drink units per day (equivalent to 20 g) in women and 3 drink units per day (equivalent to 30 g) in men, or inability to reliably quantify alcohol intake
Treatment with drugs associated with nonalcoholic fatty liver disease (NAFLD) (amiodarone, methotrexate, oral glucocorticoids at doses greater than 5 mg/day, tamoxifen, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids (such as testosterone and valproic acid) for more than 4 weeks within the last 2 months prior to the initial screening
Treatment with pioglitazone or high-dose vitamin E (>400 IU/day) within the last 2 months prior to the initial screening
Initiation of treatment with a glucagon-like peptide-1 (GLP-1) agonist or a dose change within the last 2 months prior to the initial screening
Prior or planned bariatric surgery (a prior reversed sleeve gastrectomy is permitted)
Poorly controlled type 2 diabetes mellitus as defined by hemoglobin A1c [HbA1c] 9.5% or higher or type 1 diabetes mellitus
Diabetic patients who are taking sodium/glucose cotransporter 2 (SGLT-2) inhibitors must be on a stable dose within 2 months prior to the initial screening and throughout the study
Significant weight loss within the last 6 months (e.g., > 10%)
Use of any weight-loss medication for 3 months prior to and during the study period
Body mass index (BMI) \< 18.5 kg/m2
Hepatic decompensation defined as the presence of any of the following:
- Serum albumin less than 3.5 g/dL
- International normalized ratio (INR) greater than 1.4 (unless due to therapeutic anticoagulants)
- Total bilirubin greater than 2 mg/dL with the exception of Gilbert syndrome
- History of esophageal varices, ascites, or hepatic encephalopathy
Other chronic liver diseases
- Active hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg)
- Active hepatitis C as defined by presence of hepatitis C virus antibody (HCV AB) plus a positive HCV RNA
- History or evidence of current active autoimmune hepatitis
- History or evidence of primary biliary cholangitis (PBC)
- History or evidence of primary sclerosing cholangitis
- History or evidence of Wilson's disease
- History or evidence of alpha-1-antitrypsin deficiency
- History or evidence of hemochromatosis
- History or evidence of drug-induced liver disease, as defined exposure and history
- Known bile duct obstruction
- Suspected or proven liver cancer
ALT > 200 U/L
AST \< 20 U/L
Creatine kinase (CK) > upper limit of normal (ULN)
Serum creatinine > ULN
Platelet \< lower limit of normal (LLN)
Inability to obtain a liver biopsy
History of biliary diversion
Known history of human immunodeficiency virus (HIV) infection
History of malignancy diagnosed or treated within 2 years
- Recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted
- Cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
- Participants under active evaluation for malignancy are not eligible
Active substance abuse, based on Investigator judgment, including inhaled or injected drugs, within 1 year prior to the initial screening
Females who are pregnant or breastfeeding
Patients unable to undergo MRI-PDFF due to:
- Contraindication to MRI examination
- Severe claustrophobia impacting ability to perform MRI during the study, despite mild sedation/treatment with an anxiolytic
- Weight or girth exceeds the scanner capacities
Treatment with any other investigational therapy or device within 30 days or within five half-lives, whichever is longer, prior to the initial screening
Active, serious medical disease with likely life expectancy \< 5 years
Any other condition(s) that would compromise the safety of the subject or compromise study quality as judged by the Investigator

OLE Phase Enrollment Criteria

Subjects must fulfill the following before allowing to start OLE dosing:

Provide informed consent on or before Day 1 and prior to any OLE-related study procedures.
Completed through the Week 52 biopsy and Week 56 lab assessments in the DB phase
Meet the above DB phase Inclusion and Exclusion Criteria before Day 1 of the OLE phase, with the exception of the following:
- AST \< 20 U/L
- Inability to obtain a liver biopsy (no new biopsy required for OLE)
- Unable to undergo MRI-PDFF (no imaging performed in OLE)

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 181 participants (actual)

Study arms

Experimental
Seladelpar 10 mg
Subjects enrolled will receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks.
Drug: Seladelpar
Experimental
Seladelpar 20 mg
Subjects enrolled will receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks.
Drug: Seladelpar
Experimental
Seladelpar 50 mg
Subjects enrolled will receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks.
Drug: Seladelpar
Placebo comparator
Placebo
Subjects enrolled will receive seladelpar 10 mg, 20 mg, 50 mg or placebo daily for 52 weeks.
Drug: Placebos

Interventions

DrugSeladelpar
10 mg, 20 mg, or 50 mg
Also known as: MBX-8025
DrugPlacebos
Matching placebo Capsule

What researchers measure

Primary outcomes

Percentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF)
Evaluate the effect of seladelpar on hepatic fat fraction, as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12 in the double-blind (DB) phase. MRI-PDFF Relative (Percent) Change From Baseline to Week 12 - ANCOVA - mITT Population MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-based biomarker of liver triglyceride concentration.
Time frame: Week 12

Secondary outcomes

Percentage of Participants With Improvement of 2 Points or More in the Nonalcoholic Fatty Liver Disease Activity Score (NAS)
Histopathology nonalcoholic fatty liver disease activity score (NAS) change from baseline ≤-2 (Improvements of 2 points or more in NAS) - mITT Population Total NAS score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8. Diagnosis of NASH (or, alternatively, fatty liver not diagnostic of NASH) should be made first, then NAS is used to grade activity. NAS scores of 0-2 occurred in cases largely considered not diagnostic of NASH, scores of 3-4 were evenly divided among those considered not diagnostic, borderline, or positive for NASH. Scores of 5-8 occurred in cases that were largely considered diagnostic of NASH
Time frame: Week 52
Percent Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 and Week 52
Alanine Aminotransferase (ALT) Relative (percent) change of from Baseline to Weeks 12 and Week 52 - mITT Population A decreased serum levels of alanine aminotransferase (ALT) is a marker of liver function improvement.
Time frame: Week 12, Week 52
Percent Change From Baseline in Aspartate Aminotransferase (AST) at Week 12 and Week 52
Relative (Percent) Change of Aspartate Aminotransferase (AST) From Baseline to Weeks 12 and Week 52 - mITT Population A decreased serum levels of Aspartate Aminotransferase (AST) is a marker of liver function improvement.
Time frame: Weeks 12, Week 52
Percent Change From Baseline in Gamma Glutamyl Transferase (GGT) at Week 12 and Week 52
Relative (Percent) Change of Gamma Glutamyl Transferase (GGT) From Baseline to Weeks 12 and Week 52 - mITT Population A decreased serum levels of Gamma Glutamyl Transferase (GGT) is a marker of liver function improvement.
Time frame: Weeks 12, Week 52
Number of Participants With Decrease in MRI-PDFF ≥ 30% From Baseline at Week 12 and Week 52
Number of Participants with a relative decrease in MRI-PDFF ≥30% (ie, percent change ≥ 30%) at Weeks 12, and 52/ET (Early Termination) in the DB phase - mITT Population. MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-based biomarker of liver triglyceride concentration. MRI-PDFF response defined as ≥30% relative decline in MRI-PDFF is associated with ≥1 stage improvement in fibrosis and may be used as a surrogate marker of fibrosis regression in early phase clinical trials for NASH
Time frame: Week 12, Week 52
Percentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF) at Week 52
Percentage Change from Baseline in MRI-PDFF to Weeks 52//ET - mITT Population MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-based biomarker of liver triglyceride concentration.
Time frame: Week 52
Number of Liver Biopsy Responders With Reversal of NASH Reversal of NASH (Ballooning Score of 0 and Lobular Inflammation Score of 0 or 1) and no Worsening of Hepatic Fibrosis at Week 52
Liver Biopsy Responders with reversal of NASH (ballooning score of 0 and lobular inflammation score of 0 or 1 and no worsening of hepatic fibrosis) at Week 52/ET. The reversal of NASH was defined as the absence of hepatocellular ballooning (score of 0) and no or minimal inflammation (lobular inflammation score of 0 or 1).
Time frame: Week 52
Percentage of Participants With Improvement by at Least 1 Stage in Fibrosis From Baseline at Week 12 and Week 52
Proportion of subjects with improvement by at least 1 stage in fibrosis without worsening of NASH (ie, improvement by at least 1 fibrosis stage without worsening of NAS) at Week 52/ET - Cochran-Mantel-Haenszel - mITTb Population There five liver fibrosis stages (F0: no scarring (no fibrosis); F1: minimal scarring; F2: scarring has occurred and extends outside the liver area (significant fibrosis); F3: fibrosis spreading and forming bridges with other fibrotic liver areas (severe fibrosis); F4: cirrhosis or advanced scarring)
Time frame: Week 52

Results

Posted Jul 5, 2022

Participant flow

DB Phase

Participant flow — DB Phase
Milestone	Period 1: Seladelpar 10 mg	Period 1: Seladelpar 20 mg	Period 1: Seladelpar 50 mg	Period 1: Placebo
Started	53	51	50	27
Completed	27	34	32	17
Not completed	26	17	18	10

OLE Phase

Participant flow — OLE Phase
Milestone	Period 1: Seladelpar 10 mg	Period 1: Seladelpar 20 mg	Period 1: Seladelpar 50 mg	Period 1: Placebo	Period 2: Seladelpar 50 mg
Started	0	0	0	0	12
Completed	0	0	0	0	0
Not completed	0	0	0	0	12

Outcome measures

PrimaryPercentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF)

Evaluate the effect of seladelpar on hepatic fat fraction, as assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) at Week 12 in the double-blind (DB) phase. MRI-PDFF Relative (Percent) Change From Baseline to Week 12 - ANCOVA - mITT Population MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-based biomarker of liver triglyceride concentration.

Time frame:: Week 12
Reported as:: Least squares mean · percentage of change from Baseline

Percentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF)
percentage of change from Baseline	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
Percentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF)	-9.76 ± 4.153	-14.24 ± 4.329	-13.00 ± 4.305	-20.78 ± 5.555

Statistical analysis

Seladelpar 10 mg vs Placebo · ANCOVA · p = 0.0874 · Ls mean of difference: 11.02 · 95% CI -1.63 to 23.67
Seladelpar 20 mg vs Placebo · ANCOVA · p = 0.3151 · Ls mean of difference: 6.54 · 95% CI -6.28 to 19.37
Seladelpar 50 mg vs Placebo · ANCOVA · p = 0.2313 · Ls mean of difference: 7.78 · 95% CI -5.01 to 20.58

SecondaryPercentage of Participants With Improvement of 2 Points or More in the Nonalcoholic Fatty Liver Disease Activity Score (NAS)

Histopathology nonalcoholic fatty liver disease activity score (NAS) change from baseline ≤-2 (Improvements of 2 points or more in NAS) - mITT Population Total NAS score represents the sum of scores for steatosis, lobular inflammation, and ballooning, and ranges from 0-8. Diagnosis of NASH (or, alternatively, fatty liver not diagnostic of NASH) should be made first, then NAS is used to grade activity. NAS scores of 0-2 occurred in cases largely considered not diagnostic of NASH, scores of 3-4 were evenly divided among those considered not diagnostic, borderline, or positive for NASH. Scores of 5-8 occurred in cases that were largely considered diagnostic of NASH

Time frame:: Week 52
Reported as:: Number · Percentage of Participants

Percentage of Participants With Improvement of 2 Points or More in the Nonalcoholic Fatty Liver Disease Activity Score (NAS)
Percentage of Participants	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
Percentage of Participants With Improvement of 2 Points or More in the Nonalcoholic Fatty Liver Disease Activity Score (NAS)	23.1	45.2	37.0	32.0

SecondaryPercent Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 and Week 52

Alanine Aminotransferase (ALT) Relative (percent) change of from Baseline to Weeks 12 and Week 52 - mITT Population A decreased serum levels of alanine aminotransferase (ALT) is a marker of liver function improvement.

Time frame:: Week 12, Week 52
Reported as:: Least squares mean · percentage of change from Baseline

Percent Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 and Week 52
percentage of change from Baseline	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
Week 12	-24.05 ± 4.154	-32.92 ± 4.075	-38.29 ± 3.907	-9.57 ± 5.034
Week 52	-28.60 ± 5.044	-43.93 ± 4.844	-40.60 ± 4.682	-2.26 ± 6.252

SecondaryPercent Change From Baseline in Aspartate Aminotransferase (AST) at Week 12 and Week 52

Relative (Percent) Change of Aspartate Aminotransferase (AST) From Baseline to Weeks 12 and Week 52 - mITT Population A decreased serum levels of Aspartate Aminotransferase (AST) is a marker of liver function improvement.

Time frame:: Weeks 12, Week 52
Reported as:: Least squares mean · percentage of change from baseline

Percent Change From Baseline in Aspartate Aminotransferase (AST) at Week 12 and Week 52
percentage of change from baseline	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
Week 12	-14.02 ± 4.793	-16.03 ± 4.686	-17.88 ± 4.491	-14.75 ± 5.834
Week 52	-20.62 ± 5.988	-26.43 ± 5.698	-18.43 ± 5.536	-4.54 ± 7.490

SecondaryPercent Change From Baseline in Gamma Glutamyl Transferase (GGT) at Week 12 and Week 52

Relative (Percent) Change of Gamma Glutamyl Transferase (GGT) From Baseline to Weeks 12 and Week 52 - mITT Population A decreased serum levels of Gamma Glutamyl Transferase (GGT) is a marker of liver function improvement.

Time frame:: Weeks 12, Week 52
Reported as:: Least squares mean · Percentage of change from Baseline

Percent Change From Baseline in Gamma Glutamyl Transferase (GGT) at Week 12 and Week 52
Percentage of change from Baseline	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
Week 12	-28.67 ± 3.848	-37.78 ± 3.760	-42.50 ± 3.626	-6.40 ± 4.630
Week 52	-27.93 ± 5.674	-45.84 ± 5.401	-35.11 ± 5.255	0.71 ± 7.093

SecondaryNumber of Participants With Decrease in MRI-PDFF ≥ 30% From Baseline at Week 12 and Week 52

Number of Participants with a relative decrease in MRI-PDFF ≥30% (ie, percent change ≥ 30%) at Weeks 12, and 52/ET (Early Termination) in the DB phase - mITT Population. MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-based biomarker of liver triglyceride concentration. MRI-PDFF response defined as ≥30% relative decline in MRI-PDFF is associated with ≥1 stage improvement in fibrosis and may be used as a surrogate marker of fibrosis regression in early phase clinical trials for NASH

Time frame:: Week 12, Week 52
Reported as:: Count of participants · Participants

Number of Participants With Decrease in MRI-PDFF ≥ 30% From Baseline at Week 12 and Week 52
Participants	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
Week 12	12	12	9	8
Week 52/ET	8	19	8	5

SecondaryPercentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF) at Week 52

Percentage Change from Baseline in MRI-PDFF to Weeks 52//ET - mITT Population MRI-PDFF exam was used to quantify the hepatic proton density fat fraction noninvasively. The fat fraction is the proportion of mobile protons in liver tissue attributable to fat and thus, is a noninvasive magnetic resonance-based biomarker of liver triglyceride concentration.

Time frame:: Week 52
Reported as:: Mean · percentage of change from Baseline

Percentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF) at Week 52
percentage of change from Baseline	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
Percentage Change From Baseline in Magnetic Resonance Imaging-proton Density Fat Fraction (MRI-PDFF) at Week 52	-9.76 ± 27.323	-23.98 ± 30.666	-7.99 ± 30.650	-18.30 ± 27.872

SecondaryNumber of Liver Biopsy Responders With Reversal of NASH Reversal of NASH (Ballooning Score of 0 and Lobular Inflammation Score of 0 or 1) and no Worsening of Hepatic Fibrosis at Week 52

Liver Biopsy Responders with reversal of NASH (ballooning score of 0 and lobular inflammation score of 0 or 1 and no worsening of hepatic fibrosis) at Week 52/ET. The reversal of NASH was defined as the absence of hepatocellular ballooning (score of 0) and no or minimal inflammation (lobular inflammation score of 0 or 1).

Time frame:: Week 52
Reported as:: Count of participants · Participants

Number of Liver Biopsy Responders With Reversal of NASH Reversal of NASH (Ballooning Score of 0 and Lobular Inflammation Score of 0 or 1) and no Worsening of Hepatic Fibrosis at Week 52
Participants	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
Number of Liver Biopsy Responders With Reversal of NASH Reversal of NASH (Ballooning Score of 0 and Lobular Inflammation Score of 0 or 1) and no Worsening of Hepatic Fibrosis at Week 52	4	8	12	2

SecondaryPercentage of Participants With Improvement by at Least 1 Stage in Fibrosis From Baseline at Week 12 and Week 52

Proportion of subjects with improvement by at least 1 stage in fibrosis without worsening of NASH (ie, improvement by at least 1 fibrosis stage without worsening of NAS) at Week 52/ET - Cochran-Mantel-Haenszel - mITTb Population There five liver fibrosis stages (F0: no scarring (no fibrosis); F1: minimal scarring; F2: scarring has occurred and extends outside the liver area (significant fibrosis); F3: fibrosis spreading and forming bridges with other fibrotic liver areas (severe fibrosis); F4: cirrhosis or advanced scarring)

Time frame:: Week 52
Reported as:: Count of participants · Participants

Percentage of Participants With Improvement by at Least 1 Stage in Fibrosis From Baseline at Week 12 and Week 52
Participants	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
Percentage of Participants With Improvement by at Least 1 Stage in Fibrosis From Baseline at Week 12 and Week 52	9	10	17	5

Adverse events

Collected over Through DB Phase (from first dose of DB phase study drug, and up to 30 days after last dose of DB phase study drug or 1 day before the first dose of OLE phase, whichever was earlier), up to 56 weeks. AEs are only summarized in DB phase, not OLE phase.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Seladelpar 10 mg	0/53 (0%)	1/53 (1.9%)	45/53 (84.9%)
Seladelpar 20 mg	0/51 (0%)	3/51 (5.9%)	49/51 (96.1%)
Seladelpar 50 mg	0/50 (0%)	5/50 (10%)	48/50 (96%)
Placebo	0/27 (0%)	0/27 (0%)	25/27 (92.6%)

Most frequent serious events

Most frequent serious events
Event	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
DiverticulitisInfections and infestations	0/53	0/51	2/50	0/27
Faeces discolouredGastrointestinal disorders	0/53	0/51	1/50	0/27
Non-cardiac chest painGeneral disorders	0/53	1/51	1/50	0/27
Gastroenteritis Escherichia coliInfections and infestations	0/53	0/51	1/50	0/27
Intentional overdoseInjury, poisoning and procedural complications	0/53	0/51	1/50	0/27
Procedural painInjury, poisoning and procedural complications	0/53	0/51	1/50	0/27
Obstructive pancreatitisGastrointestinal disorders	0/53	1/51	0/50	0/27
DizzinessNervous system disorders	0/53	1/51	0/50	0/27
PneumoniaInfections and infestations	1/53	0/51	0/50	0/27
Post procedural complicationInjury, poisoning and procedural complications	1/53	0/51	0/50	0/27

Most frequent other events

Showing 10 of 36

Most frequent other events
Event	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo
HeadacheNervous system disorders	6/53	10/51	2/50	2/27
NauseaGastrointestinal disorders	7/53	8/51	6/50	4/27
Diabetes mellitus inadequate controlMetabolism and nutrition disorders	8/53	2/51	6/50	4/27
Back painMusculoskeletal and connective tissue disorders	1/53	5/51	2/50	4/27
ArthralgiaMusculoskeletal and connective tissue disorders	4/53	7/51	4/50	1/27
Urinary tract infectionInfections and infestations	0/53	5/51	6/50	3/27
DiarrhoeaGastrointestinal disorders	2/53	6/51	2/50	0/27
Abdominal pain upperGastrointestinal disorders	6/53	4/51	3/50	3/27
HypertensionVascular disorders	6/53	2/51	1/50	3/27
ConstipationGastrointestinal disorders	3/53	4/51	5/50	3/27

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo	Total
Mean	53.3 ± 12.48	56.6 ± 11.74	53.7 ± 11.18	53.9 ± 10.27	54.4 ± 11.60

Sex: Female, Male
Sex: Female, Male(Participants)	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo	Total
Female	36	35	33	18	122
Male	17	16	17	9	59

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo	Total
White	50	47	49	27	173
Black or African American	1	1	0	0	2
Asian	1	1	1	0	3
American Indian or Alaska native	1	1	0	0	2
Multiple	0	1	0	0	1

Region of Enrollment
Region of Enrollment(participants)	Seladelpar 10 mg	Seladelpar 20 mg	Seladelpar 50 mg	Placebo	Total
United States	53	51	50	27	181

Study locations

14 sites

CymaBay Research Site
Glendale, Arizona 85306, United States
CymaBay Research Site
Tucson, Arizona 85712, United States
CymaBay Research Site
Los Angeles, California 90057, United States
CymaBay Research Site
Boca Raton, Florida 33434, United States
CymaBay Research Site
Lakewood Ranch, Florida 34211, United States
CymaBay Research Site
Flowood, Mississippi 39232, United States
CymaBay Research Site
Clarksville, Tennessee 37040, United States
CymaBay Research Site
Germantown, Tennessee 38138, United States
CymaBay Research Site
Hermitage, Tennessee 37076, United States
CymaBay Research Site
Knoxville, Tennessee 37909, United States
CymaBay Research Site
Chandler, Texas 85224, United States
CymaBay Research Site
Dallas, Texas 75246, United States
CymaBay Research Site
Live Oak, Texas 78233, United States
CymaBay Research Site
Rollingwood, Texas 78746, United States

References and documents

Publications

Beyer C, Hutton C, Andersson A, Imajo K, Nakajima A, Kiker D, Banerjee R, Dennis A. Comparison between magnetic resonance and ultrasound-derived indicators of hepatic steatosis in a pooled NAFLD cohort. PLoS One. 2021 Apr 1;16(4):e0249491. doi: 10.1371/journal.pone.0249491. eCollection 2021. PubMed 33793651 ↗

Study documents

Study protocol · Dec 20, 2019
Statistical analysis plan · Feb 28, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03551522
Lead sponsor: Gilead Sciences
Responsible party: Sponsor
First posted: Jun 11, 2018
Start date: Apr 30, 2018
Primary completion: May 8, 2019
Completion: Aug 10, 2020
Results posted: Jul 5, 2022
Last update: Sep 15, 2022

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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