Trials / Terminated
TerminatedNCT02787304
Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)
A Phase 2 Double-blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability and Efficacy of Volixibat Potassium, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi) in Adults With Nonalcoholic Steatohepatitis (NASH)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 197 (actual)
- Sponsor
- Mirum Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if the investigational treatment volixibat (SHP626) is safe, tolerable and effective in adults with nonalcoholic steatohepatitis (NASH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHP626 | 5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion |
| DRUG | Placebo | Matching placebo |
Timeline
- Start date
- 2016-10-24
- Primary completion
- 2018-07-27
- Completion
- 2018-07-27
- First posted
- 2016-06-01
- Last updated
- 2019-11-25
- Results posted
- 2019-11-25
Locations
65 sites across 4 countries: United States, Canada, Puerto Rico, United Kingdom
Source: ClinicalTrials.gov record NCT02787304. Inclusion in this directory is not an endorsement.