NCT03421431

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis

A Phase 2 Dose Ranging, Randomized, Double Blind, and Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis

Conditions

• Non-Alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	EDP-305 Dose 1	Two tablets daily for 12 weeks
DRUG	EDP-305 Dose 2	Two tablets daily for 12 weeks
DRUG	Placebo	Two tablets daily for 12 weeks

Timeline

• Start date: 2018-04-25
• Primary completion: 2019-06-14
• Completion: 2019-07-10
• First posted: 2018-02-05
• Last updated: 2021-09-16
• Results posted: 2021-09-16

Locations

82 sites across 6 countries: United States, Canada, France, New Zealand, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study