← Trials/Trial dossier/NCT05881837

CompletedPhase 2

Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Asset

HRS9531

Subcutaneous · GLP-1 / GIP dual

Listed sites

26

Recruiting sites

Enrollment

249

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≤40

Primary endpoint

Body weight, % 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 IDNCT05881837
Org study IDHRS9531-201

Timeline

Milestones

Study first posted2023-05-31actual
Study start2023-06-13actual
Primary completion2024-10-13actual
Study completion2024-10-13actual
Last update posted2025-04-30actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Able and willing to provide a written informed consent;

2. Male or female subjects, 18-65 years of age at the time of signing informed consent;

3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;

4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.

Exclusion criteria

1. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;

2. Uncontrollable hypertension;

3. PHQ-9 score ≥15;

4. Medical history or illness that affects your weight;

5. History of diabetes;

6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;

7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;

8. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;

9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;

10. History of alcohol and/or substance abuse or drug abuse within 1 year prior to screening;

11. Use of any medication or treatment that may have caused significant weight change within 3 months;

12. History of bariatric surgery;

13. Known or suspected hypersensitivity to trial product(s) or related products;

14. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;

15. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;

16. Surgery is planned during the trial;

17. Mentally incapacitated or speech-impaired;

18. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

19. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Endpoints (21)

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
12
Glycemic / diabetes
4
Cardiometabolic biomarkers
4
Safety / tolerability / PK
1

Weight & body composition

12 endpoints
Primary/protocol endpoint

Percentage change in body weight

Time frame:Week 0, Week 24

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment

Time frame:Week 24

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment

Time frame:Week 24

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body weight after 24 weeks of treatment

Time frame:Week 0, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference after 24 weeks of treatment

Time frame:Week 0, Week 24

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in BMI after 24 weeks of treatment

Time frame:Week 0, Week 24

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage change in body weight

Time frame:Week 0, Week 32

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment

Time frame:Week 32

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment

Time frame:Week 32

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body weight after 32 weeks of treatment

Time frame:Week 0, Week 32

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference after 32 weeks of treatment

Time frame:Week 0, Week 32

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in BMI after 32 weeks of treatment

Time frame:Week 0, Week 32

BMI, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment

Time frame:Week 0, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment

Time frame:Week 0, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment

Time frame:Week 0, Week 32

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment

Time frame:Week 0, Week 32

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Change from baseline in blood pressure after 24 weeks of treatment

Time frame:Week 0, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in total cholesterol after 24 weeks of treatment

Time frame:Week 0, Week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change from baseline in blood pressure after 32 weeks of treatment

Time frame:Week 0, Week 32

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in total cholesterol after 32 weeks of treatment

Time frame:Week 0, Week 32

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of AEs During the Trial

Time frame:Week 0 to Week 56

Treatment-emergent AEs (any)

event count, event

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.