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ACTIVE NOT RECRUITING
NCT06672172
PHASE3

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.

View on ClinicalTrials.gov

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

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China