Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

NCT03987074 · Completed

Last updated 2026-05-28

This clinical trial tests the safety and side effects of different treatments, alone and in combination, in adults with nonalcoholic steatohepatitis (NASH).

Status Completed The study has finished.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 109 people

Who can join Ages 18–75 · all sexes

Timeline Started 2019-07 · est. completion 2020-07

Where 18 sites · United States

What this study is testing ClinicalTrials.gov NCT03987074 ↗

Description as written by the study sponsor.

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

Treatments tested

Semaglutide Drug

Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly
Firsocostat also known as GS-0976 Drug

Tablets administered orally once daily
Cilofexor also known as GS-9674 Drug

Tablets administered orally once daily

Main thing measured	Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Sponsor	Gilead Sciences
Conditions studied	Nonalcoholic Steatohepatitis
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03987074 ↗