Trials / Completed
CompletedNCT05193916
A Phase II Clinical Trial of Chiglitazar for NASH
A Multi-Center, Randomised, Double-blind, Placebo Controlled Phase II Clinical Study of Chiglitazar in Patients With Nonalcoholic Steatohepatitis Accompanied by Elevated Triglycerides and Insulin Resistance
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Chipscreen Biosciences, Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study is to evaluate the efficacy and safety of chiglitazar monotherapy in patients with non-clcoholic steatohepatitis (NASH).
Detailed description
The study is a non-invasive exploratory phase II trial in patients who were clinically diagnosed as non-alcoholic steatohepatitis (NASH) with liver fibrosis accompanied by elevated triglycerides (TG) and insulin resistance. The efficacy and safety of chiglitazar tablets 48mg and 64mg will be compared with placebo in the 18-week-treament.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | chiglitazar sodium tablets | the drugs will be given orally once a day |
| DRUG | Placebo | no active drug contained |
Timeline
- Start date
- 2022-03-21
- Primary completion
- 2024-01-02
- Completion
- 2024-01-02
- First posted
- 2022-01-18
- Last updated
- 2024-05-28
Locations
15 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05193916. Inclusion in this directory is not an endorsement.