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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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 endpointsPercent Change From Baseline in Body Weight
Time frame:Baseline, Week 32
percent change from baseline, improvement
Percent Change From Baseline in Body Weight
Time frame:Baseline, Week 40
percent change from baseline, improvement
Change From Baseline in Body Weight
Time frame:Baseline, Week 32 and 40
change from baseline, improvement
Change from Baseline in Body Mass Index (BMI)
Time frame:Baseline, Week 32 and 40
change from baseline, improvement
Change from Baseline in Waist Circumference
Time frame:Baseline, Week 32 and 40
change from baseline, improvement
Glycemic / diabetes
1 endpointChange from Baseline in Glucose Level
Time frame:Baseline, Week 32 and 40
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChange from Baseline in Blood Pressure
Time frame:Baseline, Week 32 and 40
change from baseline, improvement
Safety / tolerability / PK
1 endpointTEAEs
Time frame:Baseline, Week 44
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 November 5, 2026 snapshot.