Trials / Withdrawn
WithdrawnNCT05118360
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH
A Seamless Phase 2a/2b, Double-Blind, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41, a Thyroid Hormone Receptor β Agonist, in Adults With Nonalcoholic Steatohepatitis (NASH)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Gannex Pharma Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 2, randomized, double-blind, placebo controlled study in adults with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of ASC41 in adults with NASH.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ASC41 2 mg | 2mg of ASC41 orally once daily for 52 weeks |
| DRUG | ASC41 4 mg | 4mg of ASC41 orally once daily for 52 weeks |
| DRUG | Placebo | Matching placebo orally once daily for 52 weeks. |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2024-11-10
- Completion
- 2025-01-09
- First posted
- 2021-11-12
- Last updated
- 2024-09-27
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05118360. Inclusion in this directory is not an endorsement.