NCT03987074

Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Semaglutide	Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly
DRUG	Firsocostat	Tablets administered orally once daily
DRUG	Cilofexor	Tablets administered orally once daily

Timeline

• Start date: 2019-07-29
• Primary completion: 2020-07-13
• Completion: 2020-07-13
• First posted: 2019-06-14
• Last updated: 2021-07-15
• Results posted: 2021-07-15

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study