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A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise
Sponsor: Shandong Suncadia Medicine Co., Ltd.
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
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
284
Start Date
2024-09-25
Completion Date
2026-04-21
Last Updated
2025-04-23
Healthy Volunteers
No
Conditions
Interventions
HRS-7535 tablet
HRS-7535 tablet; low dose
HRS-7535 tablet
HRS-7535 tablet; middle dose
HRS-7535 tablet
HRS-7535 tablet; high dose
HRS-7535 placebo tablet
HRS-7535 placebo tablet
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China