Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis

Nonalcoholic Steatohepatitis (NASH) Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-0976 in Subjects With Nonalcoholic Steatohepatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856555
• Other study ID #: GS-US-426-3989
• Status: Completed
• Phase: Phase 2
• Start date: August 8, 2016
• Est. completion date: July 18, 2017

Study information

• Verified date: July 2020
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and tolerability of firsocostat in adults with nonalcoholic steatohepatitis (NASH).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 18, 2017
• Est. primary completion date: July 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• 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

• OR

• 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

Key Exclusion Criteria:

• 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

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis (NASH)

Intervention

Drug:
• Firsocostat
Capsules orally once daily.
• Placebo
Placebo matched to firsocostat orally once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 si

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing Treatment-Emergent Adverse Events		First Dose date up to last dose (Week 12) plus 30 days