Testing HRS-5817 injections for safety in adults with obesity

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Injections of HRS-5817 Injection in Healthy Adult Volunteers With or Without Obesity

This will test whether subcutaneous HRS-5817 injections are safe and how the body processes them in adults with obesity.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06934408 on ClinicalTrials.gov

What this trial studies

This is a Phase I, placebo-controlled study giving single and multiple subcutaneous doses of HRS-5817 to adults with obesity to characterize safety, tolerability, pharmacokinetics and pharmacodynamics. Participants will be generally healthy adults aged 18–55 with stable weight and will receive either HRS-5817 injection or placebo with scheduled clinic visits for monitoring. Safety monitoring includes vital signs, laboratory tests, ECGs, and collection of blood samples to measure drug levels and biological effects. The goal is to define the safety profile and how the drug behaves in the body to inform later-stage studies.

Who should consider this trial

Good fit: Adults aged 18–55 with obesity who are generally healthy, have had no major weight change in the past 3 months, and agree to required contraceptive measures (if applicable) are ideal candidates.

Not a fit: People outside the age range, with significant medical problems, unstable weight, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, this could identify a new injectable medication approach that might eventually help people manage obesity.

How similar studies have performed: Other early human studies of injectable obesity medications have led to approved therapies, but HRS-5817 itself is being tested in humans in this early-phase trial.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui

• The Second Hospital of Anhui Medical Uniersity — Hefei, Anhui, China (Recruiting)

Study contacts

• Study coordinator: Sheng Feng

Conditions Obesity; Overweight