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Active not recruitingPhase 3

the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone

Asset

HRS9531

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

218

actual

Study population

Type 2 diabetes

Key I/E criterion

HbA1c ≤10%

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 IDNCT06650007
Org study IDHRS9531-302

Timeline

Milestones

Study first posted2024-10-21actual
Study start2024-11-08actual
Primary completion2025-05-14actual
Last update posted2025-06-12actual
Study completion2026-07estimated (month precision)

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. Males and females, Age ≥18 years at the time of signing informed consent.

2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.

3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening.

4. 7.5% ≤ HbA1c ≤10.0% at screening.

Exclusion criteria

1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.

2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.

3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).

4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ;

5. Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening.

6. Participated in clinical trials of any drug or medical device within 3 months prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).

Endpoints (5)

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
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight

Time frame:from baseline to 36 weeks treatment

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change in HbA1c

Time frame:from baseline to 36 weeks treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of subjects with HbA1c<7.0% and ≤6.5%

Time frame:from baseline to 36 weeks treatment

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG

Time frame:from baseline to 36 weeks treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Proportion of subjects with HbA1c<7.0% and weight loss ≥5%

Time frame:from baseline to 36 weeks treatment

threshold achievement, improvement

componentsHbA1c <7.0% achievement, ≥5% weight-loss responders

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.