Trials / Completed
CompletedNCT05591079
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH
A Phase II, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of CS0159 in the Treatment of Patients With Nonalcoholic Steatohepatitis (NASH)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (actual)
- Sponsor
- Cascade Pharmaceuticals, Inc · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)
Detailed description
This will be a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PKs, and efficacy of CS0159 in the treatment of patients with NASH over 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CS0159 (Linafexor) | Oral QD |
Timeline
- Start date
- 2023-02-10
- Primary completion
- 2023-11-09
- Completion
- 2023-11-09
- First posted
- 2022-10-24
- Last updated
- 2023-11-21
Locations
17 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05591079. Inclusion in this directory is not an endorsement.