A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes

NCT ID: NCT06649344

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 884 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-09-30

Brief Summary

The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 52 weeks.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group A

HRS953-low dose

Group Type: EXPERIMENTAL

HRS9531 Injection

Intervention Type: DRUG

HRS9531 injected subcutaneously once weekly.

Treatment group B

HRS9531-high dose

Group Type: EXPERIMENTAL

HRS9531 Injection

Intervention Type: DRUG

HRS9531 injected subcutaneously once weekly.

Treatment group C

Semaglutide-1mg

Group Type: ACTIVE_COMPARATOR

Semaglutide Injection

Intervention Type: DRUG

Semaglutide injected subcutaneously once weekly.

Interventions

HRS9531 Injection

HRS9531 injected subcutaneously once weekly.

Intervention Type: DRUG

Semaglutide Injection

Semaglutide injected subcutaneously once weekly.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with type 2 diabetes ≥ 90 days；

2. Stable daily dose(s) for ≥3months prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;

3. Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;

4. Female patients of childbearing potential and male patients must agree to use highly effective contraception during the trial and for at least 2 months after the last dose of the investigational medicinal drug. Female patients of childbearing potential must test negative for pregnancy at Visit 1 and not be breastfeeding.

Exclusion Criteria

1. Known or suspected allergy or intolerance to the investigational medicinal products or related products；

2. Acute complications of diabetes occurred during the previous 6 months；

3. Serious chronic complications of diabetes in the past；

4. Use other antidiabetic drugs for ≥3months prior to screening ;

5. Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying； or gastrointestinal surgery;

6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 3 months or 5 half-lives, whichever is longer, prior to screening;

7. Any conditions that the Investigator judges might not be suitable to participate in the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhu Xianyi Memorial Hospital,Tianjin Medical University

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

HRS9531-303

Identifier Type: -

Identifier Source: org_study_id