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Completed

NCT Number: NCT06649344

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhu Xianyi Memorial Hospital,Tianjin Medical University

Tianjin, Tianjin Municipality, 300000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Known or suspected allergy or intolerance to the investigational medicinal products or related products;
  • Acute complications of diabetes occurred during the previous 6 months;
  • Serious chronic complications of diabetes in the past;
  • 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;
  • Any conditions that the Investigator judges might not be suitable to participate in the trial.

Treatment and study plan

HRS9531 injection

Drug

HRS9531 injected subcutaneously once weekly.

Semaglutide Injection

Drug

Semaglutide injected subcutaneously once weekly.

Primary outcomes

  1. Change in HbA1c

    Time frame: Week 0 to Week 36

    Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.

Secondary outcomes

  1. Change in body weight

    Time frame: Week 0 to Week 36

    Change from baseline in body weight after 36 weeks of treatment.

  2. Proportion of Subjects with HbA1c≤6.5%

    Time frame: Week 0 to Week 36

    Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment.

  3. Proportion of Subjects with HbA1c<7%

    Time frame: Week 0 to Week 36

    Proportion of subjects with HbA1c<7% after 36 weeks of treatment.

  4. Change in FPG (fasting plasma glucose)

    Time frame: Week 0 to Week 36

    Change from baseline in FPG after 36 weeks of treatment.

  5. Change in FPG (fasting plasma glucose)

    Time frame: Week 0 to Week 52

    Change from baseline in FPG after 52 weeks of treatment.

  6. 7-points SMPG profiles

    Time frame: 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.

  7. Incidence and severity of adverse events

    Time frame: Week 0 to Week 52+4 weeks follow-up

    Severity (mild, moderate and severe) is assessed by investigator.

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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