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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
Lead sponsor
Assets
HRS9531 / Semaglutide
Listed sites
1
Recruiting sites
—
Enrollment
884
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c ≤11%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointChange in body weight
Time frame:Week 0 to Week 36
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
6 endpointsChange in HbA1c
Time frame:Week 0 to Week 36
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Proportion of Subjects with HbA1c≤6.5%
Time frame:Week 0 to Week 36
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of Subjects with HbA1c<7%
Time frame:Week 0 to Week 36
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Change in FPG (fasting plasma glucose)
Time frame:Week 0 to Week 36
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in FPG (fasting plasma glucose)
Time frame:Week 0 to Week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
7-points SMPG profiles
Time frame:Week 0 to Week 36
descriptive
Safety / tolerability / PK
1 endpointIncidence and severity of adverse events
Time frame:Week 0 to Week 52+4 weeks follow-up
Treatment-emergent AEs (any)
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.