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

Last updated 2026-05-28

This study is testing whether the experimental drug HRS9531 works better than the approved drug semaglutide (both taken once a week along with metformin or metformin plus an SGLT2 inhibitor) to lower blood sugar levels in adults with type 2 diabetes.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 884 people

Who can join Ages 18+ · all sexes

Timeline Started 2024-10 · est. completion 2026-09

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06649344 ↗

Description as written by the study sponsor.

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.

Treatments tested

HRS9531 Injection Drug

HRS9531 injected subcutaneously once weekly.
Semaglutide Injection Drug

Semaglutide injected subcutaneously once weekly.

Main thing measured	Change in HbA1c
Sponsor	Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions studied	Type 2 Diabetes
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06649344 ↗