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

Shandong Suncadia Medicine

Status and phase: Completed; Phase 2

Conditions: Chronic Weight Management

Treatments: Drug: HRS-7535

Study type: Interventional

Funder types: Industry

Identifiers

NCT06671821

HRS-7535-202-Extension

Details and patient eligibility

About

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

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 4 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: HRS-7535

Group B

Experimental group

Description:

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

Treatment:

Drug: HRS-7535

Group C

Experimental group

Description:

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

Treatment:

Drug: HRS-7535

Group D

Experimental group

Description:

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

Treatment:

Drug: HRS-7535