Comparing HRS9531 and Semaglutide for Type 2 Diabetes Management

A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors

This study is testing if a new diabetes medication called HRS9531 works better and is safer than Semaglutide for people with type 2 diabetes who aren't getting good control from their current treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 840 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06649344 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of HRS9531 administered once weekly in participants with type 2 diabetes who are not adequately controlled on metformin alone or in combination with SGLT2 inhibitors. Participants will be compared to those receiving Semaglutide, another diabetes medication, over a period of 36 to 52 weeks. The goal is to determine which treatment provides better control of blood sugar levels and has a more favorable safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with type 2 diabetes for at least 90 days who are currently on stable doses of metformin, with or without SGLT2 inhibitors.

Not a fit: Patients with known allergies to the investigational drugs or those experiencing acute complications of diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for patients with type 2 diabetes who struggle to manage their condition with current therapies.

How similar studies have performed: Other studies have shown success with similar approaches in managing type 2 diabetes, indicating that this method is promising.

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.

Where this trial is running

Tianjin, Tianjin

• Zhu Xianyi Memorial Hospital,Tianjin Medical University — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Xi Meng, Bachelor

Conditions Type 2 Diabetes