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New weight loss pill HRS9531 enters final testing phase

NCT ID NCT07670884

Disease control Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This phase 3 trial tests whether HRS9531 tablets can help overweight or obese adults lose weight over 52 weeks. About 425 participants will receive either the drug or a placebo. The study measures weight change and the proportion of people losing at least 5% of their body weight.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HRS9531 tablet
What this could lead to
If successful, this could provide a new medication option for significant weight loss in people who are overweight or obese.
What could go wrong
This is a phase 3 trial, but results are not yet available. The drug may cause side effects or not work better than placebo. Long-term safety and effectiveness are still unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 675 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female subjects, 18-75 years of age at the time of signing informed consent; 2. At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity; 3. 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; 4. Able and willing to provide a written informed consent. Exclusion Criteria: 1. 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; 2. Uncontrollable severe hypertension; 3. PHQ-9 score ≥ 15; 4. Medical history or illness that affects body weight; 5. History of diabetes; 6. Acute or chronic hepatitis; 7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening; 8. Any organ-system malignancies developed within 5 years; 9. Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening; 10. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired; 11. Use of any medication or treatment that may have caused significant weight change within 90 days; 12. History of bariatric surgery; 13. Known or suspected hypersensitivity to trial product(s) or related products; 14. History of alcohol and/or substance abuse or drug abuse; 15. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 16. Surgery is planned during the trial; 17. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

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Conditions

The condition(s) this trial relates to.

obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic management of body weight

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Nanjing Drum Tower hospital

    RECRUITING

    Nanjing, Jiangsu, 210008, China

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