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

NCT06649344 | Active Not Recruiting Phase 3

• 1 other identifier: HRS9531-303
• Study Type: interventional
• Target: 884
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.

  Week 0 to Week 36

Secondary Outcomes (7)

• Change in body weight

  Week 0 to Week 36

• Proportion of Subjects with HbA1c≤6.5%

  Week 0 to Week 36

• Proportion of Subjects with HbA1c<7%

  Week 0 to Week 36

• Change in FPG (fasting plasma glucose)

  Week 0 to Week 36

• Change in FPG (fasting plasma glucose)

  Week 0 to Week 52

Study Arms (3)

Treatment group A

EXPERIMENTAL

HRS953-low dose

Drug: HRS9531 Injection

Treatment group B

EXPERIMENTAL

HRS9531-high dose

Drug: HRS9531 Injection

Treatment group C

ACTIVE COMPARATOR

Semaglutide-1mg

Drug: Semaglutide Injection

Interventions

HRS9531 Injection DRUG

HRS9531 injected subcutaneously once weekly.

Treatment group A; Treatment group B

Semaglutide Injection DRUG

Semaglutide injected subcutaneously once weekly.

Treatment group C

Eligibility Criteria

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

You may qualify if:

• Diagnosed with type 2 diabetes ≥ 90 days；
• 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;
• Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;
• 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.

You may not qualify if:

• Known or suspected allergy or intolerance to the investigational medicinal products or related products；
• Acute complications of diabetes occurred during the previous 6 months；
• Serious chronic complications of diabetes in the past；
• Use other antidiabetic drugs for ≥3months prior to screening ;
• Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying； or gastrointestinal surgery;
• 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;
• Any conditions that the Investigator judges might not be suitable to participate in the trial.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhu Xianyi Memorial Hospital,Tianjin Medical University

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 18, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CN (1)