New pill for weight and diabetes gets first human dosing test
NCT ID NCT06506175
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests how the body processes HRS9531 tablets under different dosing conditions. It involves 100 healthy adults aged 18-55 with a BMI between 23 and 35. The goal is to measure drug levels and safety, not yet to treat weight or diabetes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS9531 tablets
- What this could lead to
- If successful, this could help determine the best way to take HRS9531 for managing weight and type 2 diabetes.
- What could go wrong
- This is an early Phase 1 study in healthy people, so it won't show if the drug actually works for weight or diabetes. Side effects are possible.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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. Ability to understand the trial procedures, be able and willing to provide a written informed consent. 2. Male subject aged 18-55 years (both inclusive) at the time of signing informed consent. 3. Body weight ≥ 50.0 kg, body mass index (BMI) of 23.0-35.0 kg/m\^2 (both inclusive) at screening. 4. Weight change does not exceed 5 kg within 3 months before screening. 5. Good general health as judged by the investigator, based on medical history, physical examination, vital signs, clinical laboratory and electrocardiogram (ECG). Exclusion Criteria: 1. Known or suspected hypersensitivity to trial product(s) or related products. 2. With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study. 3. Abnormal and clinically significant blood pressure at screening. 4. History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization. 5. Blood donation within 1 month prior to screening, or blood donation ≥ 400 mL or blood loss ≥ 400 mL within 3 months prior to screening. 6. Presence of any clinically significant results in examination at screening visit. 7. Hepatitis B surface antigen (HBsAg), HIV antibody detection, treponema pallidum specific antibody detection, hepatitis C virus antibody (HCVAb) positive. 8. Presence of - clinically significant ECG results. 9. Known or suspected history of drug abuse or drug abuse, or urine drug screening test during the screening periodThose who are positive. 10. Addiction to tobacco and alcohol. 11. Individuals with special dietary habits deemed unsuitable for participation by the investigator, or those unable to adhere to the dietary requirements of the trial during the study period. 12. In the opinion of the investigator, there are any other conditions that interfere with the evaluation of the results of the trial or are not suitable for participation of this study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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The affiliated hospital of Qingdao University
Qingdao, Shandong, 266000, China
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