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

NCT ID: NCT06671821

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-20

Study Completion Date

2025-09-28

Brief Summary

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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

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Conditions

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Chronic Weight Management

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type EXPERIMENTAL

HRS-7535

Intervention Type DRUG

HRS-7535

Group B

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

Group Type EXPERIMENTAL

HRS-7535

Intervention Type DRUG

HRS-7535

Group C

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

Group Type EXPERIMENTAL

HRS-7535

Intervention Type DRUG

HRS-7535

Group D

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

Group Type EXPERIMENTAL

HRS-7535

Intervention Type DRUG

HRS-7535

Interventions

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HRS-7535

HRS-7535

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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HRS-7535-202-Extension

Identifier Type: -

Identifier Source: org_study_id

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