Fact CheckerSign in

NCT06649344CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
884 (actual)
First submitted
17 Oct 2024
Start date
31 Oct 2024
Primary completion date
18 Jul 2026
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
NCT number
NCT06649344

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 884
  • From 31 Oct 2024 to the primary completion date, 18 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Acute complications of diabetes occurred during the previous 6 months;
  • 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;

Other illness

  • Known or suspected allergy or intolerance to the investigational medicinal products or related products;
  • Serious chronic complications of diabetes in the past;
  • Any conditions that the Investigator judges might not be suitable to participate in the trial.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhu Xianyi Memorial Hospital,Tianjin Medical University
Coordinator of this site? Confirm its status
TianjinChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.