CompletedPhase 2

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

China81 participantsStarted 2024-11-20

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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.

What they're measuring

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

Timeframe: During the 32-week open-label extension treatment period

Trial details

NCT IDNCT06671821

SponsorShandong Suncadia Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-15

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