> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-hrs9531-versus-semaglutide-once-weekly-as-add-on-9132c24d-5d6f-4ff4-bf9f-aed637e26e75 > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) Participants 884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) Lead sponsor Fujian Shengdi Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) Start date 2024-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Dates **Completion date** 2026-07-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **First posted** 2024-10-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Registry last updated** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Primary completion date** 2026-07-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Start date** 2024-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Size and sites **Actual participants** 884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Participants** 884 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Lead sponsor** Fujian Shengdi Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Identifiers **Registry ID** NCT06649344 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **ClinicalTrials.gov ID** NCT06649344 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Outcomes ### Primary outcomes 1. Change in HbA1c Timeframe: Week 0 to Week 36 Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment. ### Secondary outcomes 1. Change in body weight Timeframe: Week 0 to Week 36 Change from baseline in body weight after 36 weeks of treatment. 2. 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. 3. Proportion of Subjects with HbA1c<7% Timeframe: Week 0 to Week 36 Proportion of subjects with HbA1c\\<7% after 36 weeks of treatment. 4. Change in FPG (fasting plasma glucose) Timeframe: Week 0 to Week 36 Change from baseline in FPG after 36 weeks of treatment. 5. Change in FPG (fasting plasma glucose) Timeframe: Week 0 to Week 52 Change from baseline in FPG after 52 weeks of treatment. 6. 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. 7. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Sites - Zhu Xianyi Memorial Hospital,Tianjin Medical UniversityTianjin, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06649344) ## Related records ### Drugs (1) - [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md) ### Lead sponsors (1) - [Fujian Shengdi Pharmaceutical Co., Ltd.](https://trialight.com/data/company/fujian-shengdi-pharmaceutical-co-ltd-ea809fae-fc4a-49e3-9258-58fa7ef335f8.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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