New obesity pill shows promise in early trial
NCT ID NCT06841445
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic management of body weight are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Which exercise dose best helps kids with metabolic syndrome?
- Custom knee guides put to the test in obese patients
- A pill for obesity? early human trial puts MDR-001 to the test
- Can a weekly shot help people who still struggle with weight after bariatric surgery?
- Do GLP-1 Weight-Loss drugs change how teens eat and feel?
- Can electrical muscle stimulation boost exercise benefits after menopause?