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

Shandong Suncadia Medicine Co., Ltd.81 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Weight Management

Interventions

HRS-7535DRUG

HRS-7535

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: During the 32-week open-label extension treatment period

Secondary Outcomes

Percentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;