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Not yet recruitingPhase 2

A Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Obesity

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Participants With Obesity

Asset

HRS-4729 / KAI-4729

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

1

Recruiting sites

-

Estimated enrollment

252

Study population

Obesity / overweight

Eligibility highlights

•BMI 28-40

Primary endpoint

•Body Weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07690826
Org study IDHRS-4729-202

Timeline

Milestones

Study first posted2026-07-08actual
Last update posted2026-07-08actual
Study start2026-07estimated (month precision)
Primary completion2027-03estimated (month precision)
Study completion2027-07estimated (month precision)

Assets

Investigational agents

Who this study enrolls

Obesity / overweight

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 adults aged 18 to 65 years.

3. BMI: 28.0 to 40.0 kg/m2.

4. Self-reported diet and exercise control for at least 3 months before screening, with body weight change of no more than 5 kg during the previous 3 months.

Exclusion criteria

1. Endocrine disease or history that may have a significant effect on body weight;

2. History of diabetes mellitus (gestational diabetes excepted);

3. Malignancy of any organ system within the past 5 years, irrespective of evidence of local recurrence or metastasis, except for adequately treated localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and prostate carcinoma in situ;

4. Presence or suspicion of depression, anxiety disorder, bipolar disorder, suicidal ideation, schizophrenia, or other clinically significant psychiatric disorder, or a history of suicide attempt;

5. Known or suspected excessive alcohol use, or a history of alcohol, drug, or substance abuse;

6. Acute or chronic hepatitis, or a history of severe hepatic disease other than metabolic dysfunction-associated fatty liver disease;

7. Prior or planned organ or bone marrow transplantation during the study period;

8. Any hematologic disorder that may interfere with the determination of HbA1c;

9. An autoimmune disease for which systemic corticosteroid or immunosuppressive therapy is planned during the study period;

10. Use of any medication or treatment likely to cause clinically significant weight gain or weight loss within 3 months prior to screening;

11. Participation in any clinical trial of an investigational drug or medical device within 3 months prior to screening;

12. Blood donation or blood loss ≥400 mL, or receipt of a blood transfusion, within 3 months prior to screening;

13. Mental incapacity or language impairment sufficient to preclude adequate understanding of, or participation in, the trial procedures;

14. Investigators, site staff, or other personnel directly involved in conduct of the study, and their immediate family members; employees of the Sponsor;

15. Any condition that, in the investigator's judgment, would compromise participant safety or otherwise interfere with the assessment of study results.

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
5
Glycemic / diabetes
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 32

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight

Time frame:Baseline, Week 40

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 32 and 40

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 32 and 40

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 32 and 40

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Glucose Level

Time frame:Baseline, Week 32 and 40

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Blood Pressure

Time frame:Baseline, Week 32 and 40

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

TEAEs

Time frame:Baseline, Week 44

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.