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

Phase 3

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: Semaglutide Injection; Drug: HRS9531 Injection

• Registration Number: NCT06649344
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-17
• Study First Submitted QC: 2024-10-17
• Study First Posted: 2024-10-18
• Study Start: 2024-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 840

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group C	Semaglutide Injection	Semaglutide-1mg
Treatment group A	HRS9531 Injection	HRS953-low dose
Treatment group B	HRS9531 Injection	HRS9531-high dose

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Week 0 to Week 36	Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Week 0 to Week 36	Change from baseline in body weight after 36 weeks of treatment.
Proportion of Subjects with HbA1c≤6.5%	Week 0 to Week 36	Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment.
Proportion of Subjects with HbA1c<7%	Week 0 to Week 36	Proportion of subjects with HbA1c\<7% after 36 weeks of treatment.
Change in FPG (fasting plasma glucose)	Week 0 to Week 52	Change from baseline in FPG after 52 weeks of treatment.
7-points SMPG profiles	Week 0 to Week 36	Fluctuation of 7-point SMPG. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner,120 minutes after start of dinner, before bedtime.
Incidence and severity of adverse events	Week 0 to Week 52+4 weeks follow-up	Severity (mild, moderate and severe) is assessed by investigator.

Trial Locations

Locations (1)

Zhu Xianyi Memorial Hospital,Tianjin Medical University; 🇨🇳 Tianjin, Tianjin, China