New obesity drug HRS-5817 enters first human safety trial
NCT ID NCT06934408
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new injectable drug called HRS-5817 in healthy adults, some with obesity and some without. The main goal is to check safety and how the body handles the drug, not weight loss. About 92 volunteers will receive either the drug or a placebo to gather initial data.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-5817 injection
- What this could lead to
- If successful, this could lead to a new injectable medication for weight management in people with obesity or overweight.
- What could go wrong
- This is a very early Phase 1 trial focused on safety, not weight loss. The drug may cause side effects or fail to show benefit in later 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 92 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Apr 2027
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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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. Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol. 2. Males or females aged 18-55 years old (inclusive). 3. Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests and electrocardiogram (ECG) results. 4. Body weight change (difference between the maximum body weight and the minimum body weight within 3 months) of no more than 5 kg within the past 3 months. 5. Female subjects of childbearing potential must agree to take highly effective contraceptive measures and avoid egg donation from the signing of the informed consent form to 6 months after the last dose, and must have a negative blood pregnancy test result before administration and not be breastfeeding. Male subjects whose partners are women of childbearing potential must agree to take highly effective contraceptive measures and avoid sperm donation from the signing of the informed consent form to 6 months after the last dose. Exclusion Criteria: 1. Known or suspected allergy to any ingredient in the investigational medicinal products or related products; or history of multiple and/or severe allergies to drugs or food, or history of severe anaphylaxis. 2. History of or suffering from major diseases of cardiovascular, endocrine (except primary obesity), mental, neurological, digestive, respiratory, blood, immune or genitourinary systems, which are not suitable for participation in this study as judged by the investigator. 3. Subjects who have had severe trauma or undergone major surgical procedures within 6 months before screening, or who plan to undergo surgery during the study. 4. Subjects who have participated in and used any other clinical trial drugs or medical device treatments within 3 months prior to screening or plan to do so during the study period, or within 5 half-lives of the investigational drug before screening (whichever is longer). 5. Significant changes in diet and exercise habits within 1 month before screening, or failure to maintain a basically stable lifestyle such as diet and exercise during the study. 6. Known or suspected history of drug abuse or substance abuse, or positive urine drug screening during the screening period. 7. Other situations that may interfere with the evaluation of the study results or are not suitable for participating in this study as judged by the investigator.
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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 Hospital of Anhui Medical Uniersity
RECRUITINGHefei, Anhui, 230601, China
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