DRUG
HRS9531 Injection
HRS9531 injected subcutaneously once weekly.
Status
Completed
Phase
Phase 3
Enrollment
884
Locations
1
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
HRS9531 injected subcutaneously once weekly.
DRUG
Semaglutide injected subcutaneously once weekly.
Timeline
First posted
Oct 18, 2024
Study start
Oct 31, 2024
Primary completion
Jul 18, 2026
Study completion
Jul 18, 2026
Results posted
Not reported
Registry updated
Jul 30, 2026
Outcomes
Change in HbA1c
Time frame · Week 0 to Week 36
Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.
Change in body weight
Time frame · Week 0 to Week 36
Change from baseline in body weight after 36 weeks of treatment.
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.
Proportion of Subjects with HbA1c<7%
Time frame · Week 0 to Week 36
Proportion of subjects with HbA1c\<7% after 36 weeks of treatment.
Change in FPG (fasting plasma glucose)
Time frame · Week 0 to Week 36
Change from baseline in FPG after 36 weeks of treatment.
Change in FPG (fasting plasma glucose)
Time frame · Week 0 to Week 52
Change from baseline in FPG after 52 weeks of treatment.
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.
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.
Eligibility
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.
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Zhu Xianyi Memorial Hospital,Tianjin Medical University
Tianjin, Tianjin Municipality, China
Publications
No PMID-linked publications were present in this registry snapshot.
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