CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled
Drug / intervention
Semaglutide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03987074
NCT03987074Phase 2Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Jun 14, 2019·Updated Jul 15, 2021

In Brief

A Phase 2 clinical trial evaluating Semaglutide, Firsocostat, and 1 other intervention for Nonalcoholic Steatohepatitis. Completed, enrolled 109 participants across 18 sites.

Detailed Summary

The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonalcoholic Steatohepatitis
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 14, 2019
Enrollment StartJul 29, 2019
Primary CompletionJul 13, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.0 years ago

Interventions

Semaglutidedrug

Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly

Firsocostatdrug

Tablets administered orally once daily

Cilofexordrug

Tablets administered orally once daily