Study S000863

A Proof of Concept, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Subjects With Nonalcoholic Steatohepatitis (NASH)

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03987074
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: NONE
Status: COMPLETED
Enrollment: 109
Start: 2019-07-29
Primary completion: 2020-07-13
Lead sponsor: Gilead Sciences
Conditions: Nonalcoholic Steatohepatitis
Interventions: DRUG:Semaglutide; DRUG:Firsocostat; DRUG:Cilofexor
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [First dose date up to Week 24 plus 30 days]
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities [First dose date up to 24 weeks plus 30 days]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0011197	Safety and efficacy of combination therapy with semaglutide, cilofexor and firsocostat in patients with non-alcoholic steatohepatitis: A randomised, open-label phase II trial. Alkhouri N, Journal of hepatology	2022	Randomized trial	PMID 35439567 DOI	cites ClinicalTrials.gov:NCT03987074; registry reference DERIVED:35439567