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Active not recruitingPhase 3

A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity

A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 Tablets in Subjects With Overweight or Obesity

Asset

KAI-7535 / HRS-7535

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

556

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥28

Primary endpoints

Body weightBody weight reduction of ≥ 5%

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 IDNCT06904105
Org study IDHRS-7535-303

Timeline

Milestones

Study first posted2025-04-01actual
Study start2025-04-09actual
Last update posted2025-06-22actual
Primary completion2026-05estimated (month precision)
Study completion2026-05estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. On the day of signing the informed consent form, the age should be between 18 and 75 years old.

2. At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.

3. The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%.

4. Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study.

Exclusion criteria

1. At the screening period, relevant laboratory test results are abnormal.

2. Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities.

3. Uncontrolled severe hypertension at the screening period.

4. Presence of endocrine diseases that may significantly affect the body weight.

5. History of acute or chronic pancreatitis.

6. History of significant gastrointestinal diseases.

7. Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator.

8. Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening.

9. Known or suspected abuse of alcohol or narcotics.

10. Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.

Endpoints (4)

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
3
Safety / tolerability / PK
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

The percentage change in body weight relative to the baseline.

Time frame:The 50th week after administration.

percent change from baseline, improvement

Primary/protocol endpoint

The proportion of participants with a body weight reduction of ≥ 5% relative to the baseline.

Time frame:The 50th week after administration.

threshold achievement, improvement

Secondary/protocol endpoint

The proportion of participants with a body weight reduction of ≥ 10% relative to the baseline.

Time frame:The 50th week after administration.

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events (AEs).

Time frame:About 52 weeks.

descriptive

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.