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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
Lead sponsor
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 weight•Body 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsThe percentage change in body weight relative to the baseline.
Time frame:The 50th week after administration.
percent change from baseline, improvement
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
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 endpointAdverse events (AEs).
Time frame:About 52 weeks.
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 July 1, 2026 snapshot.