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Completed

NCT Number: NCT06671821

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

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

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Key information

Conditions

Chronic Weight Management

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HRS-7535

Drug

HRS-7535

Primary outcomes

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

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

Secondary outcomes

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

    Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

  2. 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;

    Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

  3. Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

    Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

  4. Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

    Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

  5. Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

    Time frame: from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

HRS-7535-202 Follow-up Study: A Long-term Evaluation of Safety, Tolerability, and Efficacy in Obese Subjects (Open-label, Extension Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 4, 2024
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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