Not Yet RecruitingPhase 3

A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

China425 participantsStarted 2026-07

Plain-language summary

This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female subjects, 18-75 years of age at the time of signing informed consent;
. At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity;
. Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;
. Able and willing to provide a written informed consent.

Exclusion criteria

. Presence of clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
. Uncontrollable severe hypertension;
. PHQ-9 score ≥ 15;
. Medical history or illness that affects body weight;
. History of diabetes;
. Acute or chronic hepatitis;
. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage change from baseline in body weight after 52 weeks of treatment

Timeframe: After 52 weeks of treatment.

Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment

Timeframe: After 52 weeks of treatment.

Trial details

NCT IDNCT07670884

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Qiannan Zhou, M.M

+86-0518-82342973 qiannan.zhou@hengrui.com

View on ClinicalTrials.gov More Chronic Management of Body Weight trials