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Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects
HRS-7535-202 Follow-up Study: A Long-term Evaluation of Safety, Tolerability, and Efficacy in Obese Subjects (Open-label, Extension Trial)
Lead sponsor
Asset
KAI-7535 / HRS-7535
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
81
actual
Study population
Obesity / overweight
Key I/E criterion
—
Primary endpoint
•Treatment-emergent Adverse Event(AE)
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. Subjects who have completed the entire 36-week treatment course of the HRS-7535-202 trial.
3. Subjects who have a full understanding of the trial content, processes, and possible adverse reactions, and are capable and willing to comply with the protocol requirements to complete this study.
Exclusion criteria
1. Participants with poor compliance during the 36-week open-label extension treatment of the HRS-7535-202 trial;
2. Pregnant, lactating, planning to conceive during the trial period, or fertile subjects unwilling to take effective contraceptive measures during the trial period.
3. Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Endpoints (6)
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
5 endpointsPercentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame:from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
percent change from baseline, improvement
Proportion of subjects with ≥5%, ≥10%, and ≥15% weight reduction from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame:from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
threshold achievement, improvement
Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame:from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
descriptive
Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame:from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
descriptive
Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Time frame:from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
descriptive
Safety / tolerability / PK
1 endpointNumber of participants with Treatment-emergent Adverse Event(AE)
Time frame:During the 32-week open-label extension treatment period
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.