Adults 18 to 75, any sex, with Nonalcoholic Steatohepatitis (NASH). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)Primary· Up to 24 weeks plus 30 days
TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.
TEAEs
Group
Value
95% CI
GS-9674 100 mg
89.3
GS-9674 30 mg
76.8
Placebo
67.9
TEAEs leading to premature discontinuation of drug
Group
Value
95% CI
GS-9674 100 mg
1.8
GS-9674 30 mg
8.9
Placebo
7.1
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory AbnormalitiesPrimary· Up to 24 weeks plus 30 days
Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.
Any Grade ≥ 1
Group
Value
95% CI
GS-9674 100 mg
89.3
GS-9674 30 mg
92.9
Placebo
92.9
Grade 1
Group
Value
95% CI
GS-9674 100 mg
35.7
GS-9674 30 mg
42.9
Placebo
50.0
Grade 2
Group
Value
95% CI
GS-9674 100 mg
37.5
GS-9674 30 mg
37.5
Placebo
25.0
Grade 3
Group
Value
95% CI
GS-9674 100 mg
7.1
GS-9674 30 mg
10.7
Placebo
14.3
Grade 4
Group
Value
95% CI
GS-9674 100 mg
8.9
GS-9674 30 mg
1.8
Placebo
3.6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 24 weeks plus 30 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
GS-9674 100 mg
Serious: 2/56 (4%)
Deaths: 0/56
GS-9674 30 mg
Serious: 2/56 (4%)
Deaths: 0/56
Placebo
Serious: 1/28 (4%)
Deaths: 0/28
Serious adverse events (6 terms)
Reaction
System
GS-9674 100 mg
GS-9674 30 mg
Placebo
Bile duct stone
Hepatobiliary disorders
—
—
—
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other recruiting trials for Nonalcoholic Steatohepatitis (NASH)
Currently open trials in the same condition.
NCT06216041 — To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects
· Phase 1
· recruiting
NCT05842512 — Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
· Phase 2
· recruiting
NCT05692492 — A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NAS
· Phase 2
· active not recruiting
NCT03572465 — Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
· recruiting
Other Gilead Sciences trials
Trials by the same sponsor.
NCT07115368 — Study of GS-1219 in Participants With HIV-1
· Phase 1
· terminated
NCT06784973 — Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
NCT06683482 — A Qualitative Study on Advanced Breast Cancer Patients and Their Caregivers in Spain
· completed
NCT06613685 — Study of Oral Weekly GS-1720 and GS-4182 Compared With Biktarvy in People With HIV-1 Who Have Not Been Treated
· Phase 2, PHASE3
· terminated
NCT06585150 — Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
· Phase 2
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gilead Sciences
Last refreshed: 29 January 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02854605.