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Completed

NCT Number: NCT06672172

A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 18-75 age years, both inclusive;
  • Type 2 diabetes mellitus diagnosed for at least 2 months before the screening visit;
  • HbA1c 7.0-10.0% (both inclusive) at screening;
  • Treated with diet and exercise, and without any antidiabetic drugs at least 8 weeks prior to screening.

Exclusion criteria

  • Known or suspected allergy to the investigational drug or its components or excipients.
  • Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
  • Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
  • Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
  • Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.

Treatment and study plan

HRS-7535 tablet

Drug

HRS-7535 tablet; low dose

HRS-7535 placebo tablet

Drug

HRS-7535 placebo tablet

Primary outcomes

  1. Change from baseline in HbA1c at 32 weeks of treatment

    Time frame: at 32 weeks

Secondary outcomes

  1. Percentage of Participants Who Achieved HbA1c <7.0% at Week 32

    Time frame: at 32 weeks

  2. Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32

    Time frame: at 32 weeks

  3. Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32

    Time frame: at 32 weeks

  4. Percentage Change from Baseline in Body Weight, from Baseline to Week 32

    Time frame: at 32 weeks

  5. Change from Baseline in Body Weight, from Baseline to Week 32

    Time frame: at 32 weeks

  6. Change from Baseline in Waist Circumference, from Baseline to Week 32

    Time frame: at 32 weeks

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study 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)

Acronym: OUTSTAND-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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