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CompletedPhase 2

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

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

NCT IDNCT06250946
Org study IDHRS-7535-202

Timeline

Milestones

Study first posted2024-02-09actual
Study start2024-02-23actual
Primary completion2025-01-22actual
Study completion2025-01-22actual
Last update posted2025-04-13actual

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. 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

Cardiometabolic biomarkers
5
Weight & body composition
4
Glycemic / diabetes
3

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percent change in body weight from baseline at Week 26

Time frame:Week 26

percent change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Percent change in body weight from baseline at Week 36

Time frame:Week 36

percent change from baseline, improvement

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Change from baseline in fasting plasma glucoseat Week 26 and Week 36

Time frame:Week 26 and Week 36

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in fasting serum insulin at Week 26 and Week 36

Time frame:Week 26 and Week 36

change from baseline, improvement

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Change 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

Secondary/protocol endpoint

Change from baseline in total cholesterol (TC) at Week 26 and Week 36

Time frame:Week 26 and Week 36

change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 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.