Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects

Phase 2

Active, not recruiting

• Conditions: Chronic Weight Management
• Interventions: Drug: HRS-7535

• Registration Number: NCT06671821
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

The Objective of this trial is to evaluate the long-term safety, tolerability, weight loss efficacy and metabolic benefits of HRS-7535 tablets inobesity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Study Start: 2024-11-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	HRS-7535	Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Group B	HRS-7535	Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Group C	HRS-7535	Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
Group D	HRS-7535	Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally

Primary Outcome Measures

Name	Time	Method
Number of participants with Treatment-emergent Adverse Event(AE)	During the 32-week open-label extension treatment period

Secondary Outcome Measures

Name	Time	Method
Percentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;	from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
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;	from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;	from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;	from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;
Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;	from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China