Trials / Recruiting
RecruitingNCT06569524
Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
A Double-blind, Placebo Randomized，Phase II Study to Evaluate the Efficacy and Safety of TQA2225/AP025 in Adults With Nonalcoholic Steatohepatitis (NASH)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TQA2225/AP025 or TQA2225/AP025 Placebo 25mg | To evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH) |
| DRUG | TQA2225/AP025 or TQA2225/AP025 Placebo 50mg | To evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH) |
Timeline
- Start date
- 2023-09-14
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2024-08-26
- Last updated
- 2024-08-26
Locations
53 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06569524. Inclusion in this directory is not an endorsement.