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

Fujian Shengdi Pharmaceutical

Status and phase: Active, not recruiting; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Semaglutide Injection; Drug: HRS9531 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06649344

HRS9531-303

Details and patient eligibility

About

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.

Enrollment: 884 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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884 participants in 3 patient groups

Treatment group A

Experimental group

Description:

HRS953-low dose

Treatment:

Drug: HRS9531 Injection

Treatment group B

Experimental group

Description:

HRS9531-high dose

Treatment:

Drug: HRS9531 Injection

Treatment group C

Active Comparator group

Description:

Semaglutide-1mg

Treatment:

Drug: Semaglutide Injection