Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects With Nonalcoholic Steatohepatitis
1 other identifier
interventional
127
1 country
36
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2016
Shorter than P25 for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedStudy Start
First participant enrolled
August 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2017
CompletedResults Posted
Study results publicly available
July 24, 2020
CompletedJuly 24, 2020
July 1, 2020
11 months
August 2, 2016
July 8, 2020
July 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
First Dose date up to last dose (Week 12) plus 30 days
Study Arms (3)
Firsocostat 5 mg
EXPERIMENTALParticipants will receive firsocostat 1 x 5 mg + 1 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.
Firsocostat 20 mg
EXPERIMENTALParticipants will receive firsocostat 2 X 10 mg + 2 x placebo matched to firsocostat 5 mg for 12 weeks.
Placebo
EXPERIMENTALParticipants will receive 2 x placebo matched to firsocostat 5 mg + 2 x placebo matched to firsocostat 10 mg for 12 weeks.
Interventions
Placebo matched to firsocostat orally once daily.
Eligibility Criteria
You may qualify if:
- Meets all of the following conditions:
- A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
- Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
- Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kPa
- A historical liver biopsy consistent with NASH and non-cirrhotic fibrosis
- Platelet count ≥ 100,000/mm\^3
- Creatinine Clearance (CLcr ) as calculated by the Cockcroft-Gault equation ≥ 60 ml/min
You may not qualify if:
- Pregnant or lactating females
- Alanine aminotransferase (ALT) \> 5 x upper limit of the normal range (ULN)
- Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
- Cirrhosis of the liver
- Prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
- Body mass index (BMI) \< 18 kg/m\^2
- International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
- Total bilirubin \> 1 x ULN, except with diagnosis of Gilbert's syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (36)
Unknown Facility
Coronado, California, 92118, United States
Unknown Facility
Foster City, California, 94404, United States
Unknown Facility
Los Angeles, California, 90036, United States
Unknown Facility
Los Angeles, California, 90048, United States
Unknown Facility
Rialto, California, 92377, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Miami, Florida, 33165, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
Kansas City, Missouri, 64131, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Statesville, North Carolina, 28677, United States
Unknown Facility
Philadelphia, Pennsylvania, 19707, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Germantown, Tennessee, 38138, United States
Unknown Facility
Memphis, Tennessee, 38104, United States
Unknown Facility
Nashville, Tennessee, 37211, United States
Unknown Facility
Arlington, Texas, 76012, United States
Unknown Facility
Live Oak, Texas, 78233, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Murray, Utah, 84107, United States
Unknown Facility
Falls Church, Virginia, 22042, United States
Unknown Facility
Richmond, Virginia, 23226, United States
Unknown Facility
Richmond, Virginia, 23249, United States
Unknown Facility
Richmond, Virginia, 23298, United States
Unknown Facility
Richland, Washington, 99352, United States
Unknown Facility
Seattle, Washington, 98104, United States
Related Publications (3)
Loomba R, Kayali Z, Noureddin M, Ruane P, Lawitz EJ, Gitlin N, Bennett M, Harting EJ, McColgan BJ, Myers RP, Subramanian GM, McHutchison JG, Middleton MS, Sirlin C, Lai M, Charlton M, Harrison SA. Acetyl-CoA carboxylase (ACC) inhibitor GS-0976 leads to significant improvements in MRI-PDFF in a Phase 2, randomized, placebo-controlled trial of patients with NASH. American Association for the Study of Liver Diseases Meeting; 2017; Washington, DC, USA.
RESULTLoomba R, Kayali Z, Noureddin M, Ruane P, Lawitz EJ, Bennett M, Wang L, Harting E, Tarrant JM, McColgan BJ, Chung C, Ray AS, Subramanian GM, Myers RP, Middleton MS, Lai M, Charlton M, Harrison SA. GS-0976 Reduces Hepatic Steatosis and Fibrosis Markers in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2018 Nov;155(5):1463-1473.e6. doi: 10.1053/j.gastro.2018.07.027. Epub 2018 Jul 27.
PMID: 30059671DERIVEDLawitz EJ, Coste A, Poordad F, Alkhouri N, Loo N, McColgan BJ, Tarrant JM, Nguyen T, Han L, Chung C, Ray AS, McHutchison JG, Subramanian GM, Myers RP, Middleton MS, Sirlin C, Loomba R, Nyangau E, Fitch M, Li K, Hellerstein M. Acetyl-CoA Carboxylase Inhibitor GS-0976 for 12 Weeks Reduces Hepatic De Novo Lipogenesis and Steatosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2018 Dec;16(12):1983-1991.e3. doi: 10.1016/j.cgh.2018.04.042. Epub 2018 Apr 26.
PMID: 29705265DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 5, 2016
Study Start
August 8, 2016
Primary Completion
July 18, 2017
Study Completion
July 18, 2017
Last Updated
July 24, 2020
Results First Posted
July 24, 2020
Record last verified: 2020-07