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New obesity pill shows promise in early trial

NCT ID NCT06841445

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed Phase 2 study tested an experimental pill called HRS9531 in 166 adults with obesity. Participants took either the drug or a placebo daily for 26 weeks. The main goal was to see how much weight they lost compared to those on placebo.

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 lead to a new oral medication for chronic weight management in people with obesity.
What could go wrong
This is a Phase 2 trial with only 166 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

166 people

The number who actually took part.

Started

Apr 2025

Finished

Jan 2026

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. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2; 4. 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; 5. Non-pregnant or lactating women. Fertile male and female (including partners) agree to use highly effective contraceptive methods. Exclusion Criteria: 1. Uncontrollable hypertension; 2. 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; 3. PHQ-9 score ≥15; 4. Medical history or illness that affects body weight; 5. History of diabetes; 6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening; 7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening; 8. Any organ-system malignancies developed within 5 years; 9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness; 10. History of alcohol and/or substance abuse or drug abuse; 11. Use of any medication or treatment that may have caused significant weight change within 3 months; 12. History of bariatric surgery; 13. Known or suspected hypersensitivity to trial product(s) or related products; 14. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 15. Surgery is planned during the trial; 16. Mentally incapacitated or speech-impaired; 17. Acute or chronic hepatitis; 18. 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.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Nanjing Drum Tower hospital

    Nanjing, Jiangsu, 210008, China

More trials for these conditions

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