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
CompletedPhase 2Results postedLast updated 26 June 2019
What this trial tests
Phase 2 trial testing SEL in Non-Alcoholic Steatohepatitis (NASH) in 72 participants. Completed in 11 October 2016.
Adults 18 to 70, any sex, with Non-Alcoholic 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.
Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ≥ 1 Laboratory AbnormalityPrimary· Baseline up to last dose plus 30 days (up to Week 28)
Treatment-emergent events began on or after the first dosing date up to 30 days after the last dosing date or led to premature discontinuation of study drug. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening) using the Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.
TEAEs
Group
Value
95% CI
SEL 6 mg
17
SEL 18 mg
15
SEL 6 mg+SIM 125 mg
9
SEL 18 mg+SIM 125 mg
9
SIM 125 mg
7
SAEs
Group
Value
95% CI
SEL 6 mg
2
SEL 18 mg
2
SEL 6 mg+SIM 125 mg
0
SEL 18 mg+SIM 125 mg
1
SIM 125 mg
0
Any Grade ≥ 1 Laboratory Abnormality
Group
Value
95% CI
SEL 6 mg
17
SEL 18 mg
21
SEL 6 mg+SIM 125 mg
9
SEL 18 mg+SIM 125 mg
10
SIM 125 mg
8
Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse EventsPrimary· Baseline up to follow up visit (Week 28)
Discontinued Study Drug
Group
Value
95% CI
SEL 6 mg
1
SEL 18 mg
2
SEL 6 mg+SIM 125 mg
0
SEL 18 mg+SIM 125 mg
0
SIM 125 mg
0
Discontinued Study
Group
Value
95% CI
SEL 6 mg
1
SEL 18 mg
1
SEL 6 mg+SIM 125 mg
0
SEL 18 mg+SIM 125 mg
0
SIM 125 mg
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to last dose plus 30 days (up to Week 28).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04026165 — Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disea
· Phase 2
· completed
NCT03449446 — Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With
· Phase 2
· completed
NCT03053050 — Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
· Phase 3
· terminated
NCT03053063 — Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
· Phase 3
· terminated
NCT02781584 — Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatiti
· Phase 2
· completed
Other recruiting trials for Non-Alcoholic Steatohepatitis (NASH)
Currently open trials in the same condition.
NCT06724913 — Efficacy and Tolerability of a Specialized Food Products for Dietary Therapeutic and Preventive Nutrition Based on Ice C
· NA
· active not recruiting
NCT03151473 — Longitudinal Observational Study Of Chinese With NAFLD/NASH
· 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 10 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: 26 June 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/NCT02466516.