Trials / Unknown
UnknownNCT05083390
Norursodeoxycholic Acid vs. Placebo in NASH
Double-blind, Randomised, Placebo-controlled, Phase IIb Trial on the Efficacy and Safety of Norursodeoxycholic Acid Tablets in Patients With Non-alcoholic Steatohepatitis (NASH)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 363 (estimated)
- Sponsor
- Dr. Falk Pharma GmbH · Industry
- Sex
- All
- Age
- 18 Years – 74 Years
- Healthy volunteers
- Not accepted
Summary
This is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase IIb trial. The trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d or 1000 mg/d norUDCA tablets vs. placebo tablets for the treatment of NASH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | norUrsodeoxycholic acid | 500 mg norUrsodeoxycholic acid or placebo film-coated tablets; 3 tablets/day |
Timeline
- Start date
- 2019-07-08
- Primary completion
- 2025-01-01
- Completion
- 2025-04-01
- First posted
- 2021-10-19
- Last updated
- 2024-02-20
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT05083390. Inclusion in this directory is not an endorsement.