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Clinical Trials in Australia / NCT07238647
Active, not recruiting Phase EARLY_PHASE1

A Trial of HRS-5817 in Obese Participants

NCT07238647 · tracked via the Priya Life Science Australia tracker
Phase
Phase EARLY_PHASE1
Started
2026-01-05
Last updated
2026-05-12

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

HRS-5817 →HRS-5817 →HRS-5817 →HRS-5817 →

HRS-5817: Single dose of HRS-5817/placebo given subcutaneously (dose level 1 )

HRS-5817: Single dose of HRS-5817/placebo given subcutaneously (dose level 2 )

HRS-5817: Single dose of HRS-5817/placebo given subcutaneously (dose level 3 )

HRS-5817: Single dose of HRS-5817/placebo given subcutaneously (dose level 4)

Study summary

The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of HRS-5817 in obese participants

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participants aged between 18 to 55 years of age (inclusive) 2. Participants with body mass index (BMI) between 30.0 kg/m2 (inclusive) to 40.0 kg/m2 (inclusive) at screening. 3. Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study. Negative pregnancy test for women of childbearing potential (WOCBP) at baseline. Men and WOCBP must agree to take highly effective contraceptive methods Exclusion Criteria: 1\. History or evidence of clinically significant disorders 2. Individuals with a weight change of more than 5kg within 3 months prior to the screening. 1. Participant with a history of or current endocrine disorders that may significantly influence body weight (e.g., Cushing's syndrome, hypothyroidism, hyperthyroidism), or with obesity resulting from pharmacotherapy, monogenic mutations, or hereditary obesity syndromes. 2. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response. 3. Use of any GLP-1 receptor agonists (including but not limited to Liraglutide, Beneglitide, Semaglutide, and Tirzepatide, etc.) or any other prescription medications, OTC drugs and dietary supplements for weight loss (including but not limited to Orlistat, Naltrexone/Bupropion, Phentermine/Topiramate, ect.). within 3 months prior to screening, and no planned use for the study duration. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Linear Perth Western Australia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07238647 on ClinicalTrials.gov ↗ ← All trials in Australia