New Weight-Loss pill enters early human testing
NCT ID NCT07150962
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests two versions of an experimental tablet called HRS9531 in people who are overweight or obese. The main goals are to compare how the body absorbs each version and to check for side effects. About 168 men aged 18-55 with a BMI between 24 and 35 will participate. This research helps determine which formulation is safer and more effective for future studies.
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 168 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- 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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Anyone
- Healthy volunteers
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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. Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent; 2. Male subjects aged 18-55 years on the date of signing informed consent (inclusive); 3. Body weight ≥65 kg, body mass index (BMI) within the range of 24.0-35.0 kg/m2 (inclusive); 4. The weight change within the previous 3 months should not exceed 5 kilograms. 5. Based on the patient's past medical history, physical examination, vital signs, laboratory tests and electrocardiogram (ECG) examinations, the researchers determined that the overall overweight and obese subjects were included. Exclusion Criteria: 1. Those who are known or suspected to be allergic to any component of the investigational drug or related products; or those who have a history of multiple or severe allergies to drugs or foods, or a history of severe immediate allergic reactions; 2. Chronic or severe medical history of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., or those with existing systemic diseases mentioned above, and judged by the investigator to be unsuitable to participate in this study; 3. Having a history of hypertension or when the researchers determine during the screening that the blood pressure is abnormal and has clinical significance; 4. Those with a history of obvious gastrointestinal diseases or related symptoms (such as nausea, vomiting, heartburn sensation or diarrhea), conditions that affect gastric emptying (such as pyloric stenosis), or who have undergone any gastrointestinal surgery (such as weight loss surgery; except for intestinal polyp resection and appendectomy), or who had acute diarrhea within the previous 7 days; diarrhea is defined as watery stools and/or more than 3 bowel movements per day; 5. Participation in clinical trials of any drug or medical device in the 3 months or 5 half-lives, whichever longer, prior to dosing; 6. Blood donation history or blood loss ≥400 mL within 3 months or ≥200 mL within 1 month before dosing, or received blood transfusion within 3 months before dosing; 7. Hepatitis B surface antigen (HBsAg), HIV antibody, hepatitis C virus antibody (HCVAb), treponema pallidum specific antibody detection, positive; 8. Those who have a history of drug abuse or drug use, or who have a positive result in the urine drug screening test during the screening period; 9. Heavy drinkers (average weekly alcohol consumption of ≥ 14 units in the six months prior to screening: 1 unit of beer = 285 mL, or spirits = 25 mL, or wine = 100 mL; average daily smoking ≥ 5 cigarettes); those unable to quit smoking and drinking during the trial; those with positive alcohol blood tests.
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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 Second Affiliated Hospital of Anhui Medical University
RECRUITINGHefei, Anhui, 230601, China
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Other studies related to the condition(s) this trial covers.
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- Could a new injection help tackle obesity? a safety trial begins
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