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New shot could help shed pounds – early trial underway

NCT ID NCT06054698

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase 2 study tested an injectable drug called HRS9531 in 61 overweight or obese adults to see if it helps with weight loss over 36 weeks. Participants received either the drug or a placebo, and researchers measured changes in body weight. The goal is to find a new treatment option for obesity.

What this could mean

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

Active substance
HRS9531 injection
What this could lead to
If successful, this could point toward a new injectable medication for weight loss in people who are overweight or obese.
What could go wrong
This is an early Phase 2 trial with only 61 participants, so results may not apply to everyone. The drug may cause side effects or fail to show meaningful weight loss compared to placebo.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

61 people

The number who actually took part.

Started

Oct 2023

Finished

Sep 2024

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 65 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. Able and willing to provide a written informed consent. 2. Male or female subjects, 18-65 years of age at the time of signing informed consent. 3. 28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI\< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit. 4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months. 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. poor-controlled hypertension. 3. PHQ-9 score ≥15. 4. Medical history of illness that affects weight. 5. History of diabetes. 6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening. 7. History of acute cardiovascular and cerebrovascular diseases. 8. Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ. 9. Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness. 10. History of alcohol , medication or drug abuse within 1 year prior to screening. 11. Use of any medication or treatment that may cause significant weight change within 3 months. 12. History of bariatric surgery. 13. Subjects participating in QT/QTc studies need to comply with relevant examinations. 14. Known or suspected hypersensitivity to trial product(s) or related products. 15. Participation in other clinical trials within 3 month prior to screening. 16. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening 17. Surgery is planned during the trial. 18. Mentally incapacitated or speech-impaired. 19. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method. 20. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members. 21. In the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference 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.

Contacts and locations

Locations

  • Jinan Central Hospital

    Jinan, Shandong, 250013, China

  • Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310016, China

  • The Affiliated Hospital of Xuzhou Medicine University

    Xuzhou, Jiangsu, 221000, China

  • Zhejiang Hospital

    Hangzhou, Zhejiang, 310007, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.