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Active not recruitingPhase 3

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

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

NCT IDNCT06649344
Org study IDHRS9531-303

Timeline

Milestones

Study first posted2024-10-18actual
Study start2024-10-31actual
Last update posted2025-06-12actual
Primary completion2026-09-30estimated
Study completion2026-09-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Glycemic / diabetes
6
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:Week 0 to Week 36

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:Week 0 to Week 36

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of Subjects with HbA1c≤6.5%

Time frame:Week 0 to Week 36

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of Subjects with HbA1c<7%

Time frame:Week 0 to Week 36

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG (fasting plasma glucose)

Time frame:Week 0 to Week 36

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in FPG (fasting plasma glucose)

Time frame:Week 0 to Week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

7-points SMPG profiles

Time frame:Week 0 to Week 36

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence and severity of adverse events

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

Treatment-emergent AEs (any)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.