Study S000339

A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)

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

Registration

Registration: NCT04971785
Acronym: WAYFIND
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 457
Start: 2021-08-09
Primary completion: 2024-11-12
Lead sponsor: Gilead Sciences
Conditions: Nonalcoholic Steatohepatitis
Interventions: DRUG:Semaglutide (SEMA); DRUG:Cilofexor (CILO)/Firsocostat (FIR); DRUG:PTM SEMA; DRUG:PTM CILO/FIR
Results posted: TRUE
Individual participant data sharing: NO
Secondary identifiers: EUDRACT_NUMBER:2021-001445-12; REGISTRY:jRCT2071210112

Registered primary outcomes

Percentage of Participants Who Achieved ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups [Week 72]

Linked records (2)

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
R0024033	Pharmacokinetics and Safety of Cilofexor and Firsocostat in Healthy Japanese and Non-Japanese Participants. Younis IR, Journal of clinical pharmacology	2024	Other trial	PMID 39213138 DOI	cites ClinicalTrials.gov:NCT04971785
R0040528	From cause to consequence: Insights into incident diabetes mellitus after hepatic steatosis Manik Aggarwal, Clinical Liver Disease	2023	Other	PMID 36938314 DOI	cites ClinicalTrials.gov:NCT04971785