Adults 18 to 75, any sex, with Nonalcoholic Steatohepatitis. 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.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)Primary· First dose date up to Week 24 plus 30 days
Treatment-emergent adverse events (TEAEs) were defined as, any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants were assessed for AEs according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Group
Value
95% CI
Semaglutide
81.0
Semaglutide + Firsocostat 20 mg
86.4
Semaglutide + Cilofexor 30 mg
81.8
Semaglutide + Cilofexor 100 mg
72.7
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
90.5
Percentage of Participants Experiencing Treatment-Emergent Laboratory AbnormalitiesPrimary· First dose date up to 24 weeks plus 30 days
Treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post-baseline up to and including the date of last dose of study drug plus 30 days, were summarized by treatment group. Graded laboratory abnormalities were defined using the grading scheme in the CTCAE 5.0.
Grade 1
Group
Value
95% CI
Semaglutide
61.9
Semaglutide + Firsocostat 20 mg
63.6
Semaglutide + Cilofexor 30 mg
36.4
Semaglutide + Cilofexor 100 mg
50.0
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
66.7
Grade 2
Group
Value
95% CI
Semaglutide
23.8
Semaglutide + Firsocostat 20 mg
22.7
Semaglutide + Cilofexor 30 mg
31.8
Semaglutide + Cilofexor 100 mg
18.2
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
9.5
Grade 3
Group
Value
95% CI
Semaglutide
0.0
Semaglutide + Firsocostat 20 mg
4.5
Semaglutide + Cilofexor 30 mg
0.0
Semaglutide + Cilofexor 100 mg
0.0
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
0.0
Grade 4
Group
Value
95% CI
Semaglutide
0.0
Semaglutide + Firsocostat 20 mg
0.0
Semaglutide + Cilofexor 30 mg
0.0
Semaglutide + Cilofexor 100 mg
9.1
Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg
0.0
Adverse events — posted to ClinicalTrials.gov
Time frame: First dose date 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.
The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07430332 — GLP-1 RA for Stage 1 Type 1 Diabetes
· Phase 2
· not yet recruiting
NCT06977438 — Promoting Healthy Children and Youth
· Phase 4
· not yet recruiting
NCT07218354 — Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial
· Phase 3
· not yet recruiting
NCT07511543 — Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy
· Phase 2
· not yet recruiting
NCT07570810 — Efficacy, Safety, and Tolerability of CS0159 Combined With Semaglutide in MAFLD Patients With Obesity and T2DM
· NA
· not yet recruiting
Other recruiting trials for Nonalcoholic Steatohepatitis
Currently open trials in the same condition.
NCT07481734 — Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
· Phase 2
· recruiting
NCT06465186 — A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
· Phase 2
· active not recruiting
NCT05526144 — Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
· Phase 2
· recruiting
NCT05330923 — Screening and Follow-up in Patients With HIV Infection Combined With Metabolic Associated Fatty Liver Disease
· recruiting
NCT04550481 — Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study
· Phase 2
· active not 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: 15 July 2021
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/NCT03987074.