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RECRUITINGEARLY_PHASE1

A Trial of HRS-5817 in Obese Participants

A Phase I, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Subcutaneous Administration of Single Ascending Doses of HRS-5817 in Obese Participants

NCT07238647•Atridia Pty Ltd.

View on ClinicalTrials.gov

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

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Linear

Perth, Western Australia, Australia

Key Dates

Start Date

January 5, 2026

Primary Completion Date

January 30, 2027

Completion Date

January 30, 2027

Last Updated

January 16, 2026

Enrollment

ESTIMATED participants

Conditions

Obesity

Interventions

HRS-5817

DRUG

HRS-5817

DRUG

HRS-5817

DRUG

HRS-5817

DRUG

Contacts

Kathy You

CONTACT

61 02 9299 0433 kathyyou@atridia.com

Eimy Minowa

CONTACT

61 432223162 eimy.minowa@atridia.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of HRS-5817 in Obese Participants

Inclusion Criteria

Exclusion Criteria

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