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

NCT06672172 | Active Not Recruiting Phase 3

• 1 other identifier: HRS-7535-301
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in HbA1c at 32 weeks of treatment

  at 32 weeks

Secondary Outcomes (6)

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

  at 32 weeks

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

  at 32 weeks

• Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32

  at 32 weeks

• Percentage Change from Baseline in Body Weight, from Baseline to Week 32

  at 32 weeks

• Change from Baseline in Body Weight, from Baseline to Week 32

  at 32 weeks

Study Arms (4)

Treatment group A: subjects will receive HRS-7535 tablet orally at dose 1

EXPERIMENTAL

Drug: HRS-7535 tablet

Treatment group B: subjects will receive HRS-7535 tablet orally at dose 2

EXPERIMENTAL

Drug: HRS-7535 tablet

Treatment group C: subjects will receive HRS-7535 tablet orally at dose 3

EXPERIMENTAL

Drug: HRS-7535 tablet

Treatment group D: subjects will receive HRS-7535 placebo tablet orally.

PLACEBO COMPARATOR

Drug: HRS-7535 placebo tablet

Interventions

HRS-7535 tablet DRUG

HRS-7535 tablet; low dose

Treatment group A: subjects will receive HRS-7535 tablet orally at dose 1

HRS-7535 placebo tablet DRUG

HRS-7535 placebo tablet

Treatment group D: subjects will receive HRS-7535 placebo tablet orally.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: September 25, 2024
• Primary Completion: November 15, 2025
• Study Completion: April 21, 2026
• Last Updated: April 23, 2025

Record last verified: 2024-10

Locations

CN (1)