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

NCT06671821 | Completed Phase 2

• 1 other identifier: HRS-7535-202-Extension
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Weight Management

Outcome Measures

Primary Outcomes (1)

• Number of participants with Treatment-emergent Adverse Event(AE)

  During the 32-week open-label extension treatment period

Secondary Outcomes (5)

• 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;

Study Arms (4)

Group A

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally

Drug: HRS-7535

Group B

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally

Drug: HRS-7535

Group C

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally

Drug: HRS-7535

Group D

EXPERIMENTAL

Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally

Drug: HRS-7535

Interventions

HRS-7535 DRUG

HRS-7535

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 18-65 years of age at the time of signing informed consent;
• Subjects who have completed the entire 36-week treatment course of the HRS-7535-202 trial.
• 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.

You may not qualify if:

• Participants with poor compliance during the 36-week open-label extension treatment of the HRS-7535-202 trial;
• Pregnant, lactating, planning to conceive during the trial period, or fertile subjects unwilling to take effective contraceptive measures during the trial period.
• Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 4, 2024
• Study Start: November 20, 2024
• Primary Completion: August 15, 2025
• Study Completion: September 28, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-10

Locations

CN (1)