Trials / Active Not Recruiting
Active Not RecruitingNCT06649344
A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes
A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 884 (actual)
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRS9531 Injection | HRS9531 injected subcutaneously once weekly. |
| DRUG | Semaglutide Injection | Semaglutide injected subcutaneously once weekly. |
Timeline
- Start date
- 2024-10-31
- Primary completion
- 2026-09-30
- Completion
- 2026-09-30
- First posted
- 2024-10-18
- Last updated
- 2025-06-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06649344. Inclusion in this directory is not an endorsement.