Trials / Active Not Recruiting
Active Not RecruitingNCT06672172
A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise
A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise (OUTSTAND-1)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 284 (actual)
- Sponsor
- Shandong Suncadia Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with placebo in subjects with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HRS-7535 tablet | HRS-7535 tablet; low dose |
| DRUG | HRS-7535 tablet | HRS-7535 tablet; middle dose |
| DRUG | HRS-7535 tablet | HRS-7535 tablet; high dose |
| DRUG | HRS-7535 placebo tablet | HRS-7535 placebo tablet |
Timeline
- Start date
- 2024-09-25
- Primary completion
- 2025-11-15
- Completion
- 2026-04-21
- First posted
- 2024-11-04
- Last updated
- 2025-04-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06672172. Inclusion in this directory is not an endorsement.