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
- Summary
- 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.
- Short title
- 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
- Official 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2026-07-18
- First posted
- 2024-10-18
- Registry last updated
- 2026-07-30
- Primary completion date
- 2026-07-18
- Start date
- 2024-10-31
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06649344
- ClinicalTrials.gov ID
- NCT06649344
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Change in HbA1c
Timeframe: Week 0 to Week 36
Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.
Change in body weight
Timeframe: Week 0 to Week 36
Change from baseline in body weight after 36 weeks of treatment.
Proportion of Subjects with HbA1c≤6.5%
Timeframe: Week 0 to Week 36
Proportion of subjects with HbA1c≤6.5% after 36 weeks of treatment.
Proportion of Subjects with HbA1c<7%
Timeframe: Week 0 to Week 36
Proportion of subjects with HbA1c\<7% after 36 weeks of treatment.
Change in FPG (fasting plasma glucose)
Timeframe: Week 0 to Week 36
Change from baseline in FPG after 36 weeks of treatment.
Change in FPG (fasting plasma glucose)
Timeframe: Week 0 to Week 52
Change from baseline in FPG after 52 weeks of treatment.
7-points SMPG profiles
Timeframe: 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.
Incidence and severity of adverse events
Timeframe: Week 0 to Week 52+4 weeks follow-up
Severity (mild, moderate and severe) is assessed by investigator.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
- Zhu Xianyi Memorial Hospital,Tianjin Medical UniversityTianjin, China
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Type 2 diabetes mellitus Primary condition