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To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese
Efficacy and Safety of HRS9531 in Overweight or Obese Participants: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Lead sponsor
Asset
HRS9531
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
567
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥28
Primary endpoints
•Body weight, % change•≥5% weight-loss responders
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Able and willing to provide a written informed consent.
2. Male or female subjects, ≥18 years of age at the time of signing informed consent.
3. At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.
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.
5. Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.
Exclusion criteria
1. Presence of clinically significant lab results 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、 in-situ cancer of the cervix and in-situ cancer of the prostate;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. Known or suspected history of alcohol and/or substance abuse or drug abuse;
11. History of acute or chronic hepatitis or other serious liver disease other than alcoholic fatty liver disease.
12. Have received or plan to have an organ or bone marrow transplant during the study.
13. The presence of any blood disorders that may interfere with HbA1c testing.
14. Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned during the study.
15. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
16. Weight loss surgery or endoscopic and/or medical device-based weight loss therapy is planned for or during the study period;
17. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
18. Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
19. Surgery is planned during the tria;
20. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process;
21. In the investigator's judgment, there are circumstances (medical, psychological, social, or geographical factors, etc.) that affect subject safety or any other conditions that interfere with the evaluation of the test results.
Endpoints (18)
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
7 endpointsPercentage change from baseline in weight after 48 weeks of treatment
Time frame:Baseline, Week 48
Body weight, % change
percent change from baseline, improvement
Proportion of subjects with weight loss of≥5% from baseline after 48 weeks of treatment
Time frame:Week 48
≥5% weight-loss responders
threshold achievement, improvement
Proportion of subjects with weight loss of ≥10% from baseline after 48 weeks of treatment
Time frame:Week 48
≥10% weight-loss responders
threshold achievement, improvement
Proportion of subjects with weight loss of ≥15% from baseline after 48 weeks of treatment
Time frame:Week 48
≥15% weight-loss responders
threshold achievement, improvement
Change from baseline in waist circumference after 48 weeks of treatment
Time frame:Baseline, Week 48
Waist circumference, change
change from baseline, improvement
Change from baseline in weight after 48 weeks of treatment
Time frame:Baseline, Week 48
Body weight, absolute change (kg)
change from baseline, improvement
Change from baseline in BMI after 48 weeks of treatment
Time frame:Baseline, Week 48
BMI, change
change from baseline, improvement
Glycemic / diabetes
3 endpointsChange from baseline in fasting plasma glucose (FPG) after 48 weeks of treatment
Time frame:Baseline, Week 48
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change from baseline in glycosylated haemoglobin (HbA1c) after 48 weeks of treatment
Time frame:Baseline, Week 48
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change from baseline in fasting serum insulin after 48 weeks of treatment
Time frame:Baseline, Week 48
change from baseline, improvement
Cardiometabolic biomarkers
6 endpointsChange from baseline in systolic blood pressure after 48 weeks of treatment
Time frame:Baseline, Week 48
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Change from baseline in diastolic blood pressure after 48 weeks of treatment
Time frame:Baseline, Week 48
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Change from baseline in Total Cholesterol after 48 weeks of treatment
Time frame:Baseline, Week 48
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol after 48 weeks of treatment
Time frame:Baseline, Week 48
LDL-C, change
change from baseline, improvement
LOINC 13457-7
Change from baseline in Triglycerides after 48 weeks of treatment
Time frame:Baseline, Week 48
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Change from baseline in High Density Lipoprotein (HDL) Cholesterol after 48 weeks of treatment
Time frame:Baseline, Week 48
HDL-C, change
change from baseline, improvement
LOINC 2085-9
Patient-reported / QoL
1 endpointChange in scores of SF-36 V2 from baseline after 48 weeks of treatment
Time frame:Baseline, Week 48
SF-36 total
change from baseline, improvement
Safety / tolerability / PK
1 endpointNumber of AEs during the trial
Time frame:week 0 to week 52
Treatment-emergent AEs (any)
event count, event
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 July 1, 2026 snapshot.