New shot could help shed pounds – early trial underway
NCT ID NCT06054698
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
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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. 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.
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
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Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
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The Affiliated Hospital of Xuzhou Medicine University
Xuzhou, Jiangsu, 221000, China
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Zhejiang Hospital
Hangzhou, Zhejiang, 310007, China
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