drugset / Trial / NCT05083390
Norursodeoxycholic Acid vs. Placebo in NASH
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-07-08
- Primary completion
- 2025-01
- Completion
- 2025-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | norUrsodeoxycholic Acid | Unknown | 1000 mg | Oral |
| Subject | norUrsodeoxycholic Acid | Unknown | 1500 mg | Oral |