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Efficacy and Safety of HRS-7535 Tablets in Obese Subjects .
A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Phase ⅡStudy to Evaluate the Efficacy and Safety of HRS-7535 in Obese Subjects
Lead sponsor
Asset
KAI-7535 / HRS-7535
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
235
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≤40
Primary endpoint
•Body weight
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. Male or female subjects, 18-65 years of age at the time of signing informed consent;
2. At screening and random visit, 28.0 ≤BMI≤ 40.0 kg/m2;
3. Diet and exercise control for at least 3 months before screening and random visit, and less than 5 % self-reported change within the last 3 months.
4. Able and willing to provide a written informed consent
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. History of diabetes;
5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
6. 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;
7. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
8. Use of any medication or treatment that may have caused significant weight change within 2 months;
9. History of bariatric surgery;
10. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
11. Surgery is planned during the trial;
12. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
13. 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 (12)
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
4 endpointsPercent change in body weight from baseline at Week 26
Time frame:Week 26
percent change from baseline, improvement
Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15% from baseline in body weight at Week 26 and Week 36
Time frame:Week 26 and Week 36
threshold achievement, improvement
Percent change in body weight from baseline at Week 36
Time frame:Week 36
percent change from baseline, improvement
Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36
Time frame:Week 26 and Week 36
change from baseline, improvement
Glycemic / diabetes
3 endpointsChange from baseline in fasting plasma glucoseat Week 26 and Week 36
Time frame:Week 26 and Week 36
change from baseline, improvement
Change from baseline in fasting serum insulin at Week 26 and Week 36
Time frame:Week 26 and Week 36
change from baseline, improvement
Change from baseline in HbA1c at Week 26 and Week 36
Time frame:Week 26 and Week 36
change from baseline, improvement
Cardiometabolic biomarkers
5 endpointsChange from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36
Time frame:Week 26 and Week 36
change from baseline, improvement
Change from baseline in total cholesterol (TC) at Week 26 and Week 36
Time frame:Week 26 and Week 36
change from baseline, improvement
Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36
Time frame:Week 26 and Week 36
change from baseline, improvement
Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3
Time frame:Week 26 and Week 3
change from baseline, improvement
Change from baseline in triglycerides (TG) at Week 26 and Week 36
Time frame:Week 26 and Week 36
change from baseline, improvement
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.