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New obesity shot tested in teens: safe or not?

NCT ID NCT07559136

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 1 time

Summary

This early-stage trial tests the safety of an investigational injection called HRS9531 in 48 Chinese adolescents aged 12 to 17 who are obese. Participants receive either the drug or a placebo, and researchers monitor side effects, drug levels in the blood, and changes in weight and waist size. The study requires participants to have maintained a stable diet and exercise routine for at least 12 weeks before joining.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

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

Started

Jun 2026

Expected to finish

Mar 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

12 to 18 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 who are aged ≥12 years and \<18 years at the time of signing the informed consent; 2. At screening, the BMI meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents"; 3. Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian); Exclusion Criteria: 1. Presence of clinically significant lab results at screening visit; 2. Uncontrollable hypertension; 3. Medical history or illness that affects your weight; 4. History of diabetes; 5. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening; 6. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness; 7. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening; 8. Pre-adolescent participants (Tanner phase I); 9. Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening. 10. Surgery is planned during the tria; 11. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process； 12. In the investigator's judgment, there are circumstances that affect subject safety or any other conditions that interfere with the evaluation of the test results.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

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

Overweight and obesity

How to take part

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

  1. The places running it

    1 site. 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

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

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