Trials / Withdrawn
WithdrawnNCT06692283
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Denifanstat in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD)/Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Sagimet Biosciences Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease (MALSD)/metabolic dysfunction-associated steatohepatitis (MASH) after 52 weeks of treatment.
Detailed description
Up to 2000 patients will be randomized to receive either denifanstat 50 mg or placebo.
Conditions
- MASLD
- MASH
- NASH
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- Metabolic Dysfunction-Associated Steatohepatitis
- Nonalcoholic Steatohepatitis
- Nonalcoholic Fatty Liver
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | denifanstat | Tablet |
| DRUG | Placebo | Matching tablet |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2026-06-01
- Completion
- 2027-06-01
- First posted
- 2024-11-18
- Last updated
- 2025-05-15
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06692283. Inclusion in this directory is not an endorsement.