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Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

Sponsored by Gilead Sciences

About this trial

Last updated 6 years ago

Study ID

GS-US-384-1497

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 9 years ago

What is this trial about?

The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib [SEL]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.

What are the Participation Requirements?

Key Inclusion Criteria:

- Males and non-pregnant, non-lactating females

- Evidence of NASH with fibrosis on biopsy

Key Exclusion Criteria:

- Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)

- Other causes of liver disease including viral hepatitis and alcoholic liver disease

- Any history of decompensated liver disease, including ascites, hepatic encephalopathy
or variceal bleeding

- History of liver transplantation

- Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1
oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine,
and a 1 oz/30 mL measure of 40% proof alcohol)

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