Trials / Recruiting
RecruitingNCT07060456
Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- 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 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRS9531 | HRS9531-low dose |
| DRUG | HRS9531 | HRS9531-high dose |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2025-07-25
- Primary completion
- 2027-02-01
- Completion
- 2027-03-01
- First posted
- 2025-07-11
- Last updated
- 2026-01-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07060456. Inclusion in this directory is not an endorsement.