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NCT Number: NCT07238647

A Trial of HRS-5817 in Obese Participants

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Linear

Perth, Western Australia, 6027, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants aged between 18 to 55 years of age (inclusive)
  • Participants with body mass index (BMI) between 30.0 kg/m2 (inclusive) to 40.0 kg/m2 (inclusive) at screening.
  • 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

  • History or evidence of clinically significant disorders 2. Individuals with a weight change of more than 5kg within 3 months prior to the screening.
  • 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.
  • 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.
  • 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

Treatment and study plan

HRS-5817

Drug

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

Primary outcomes

  1. Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events

    Time frame: Day 253

    Number of participants with Adverse events and Serious adverse events

Secondary outcomes

  1. Pharmacokinetics - Cmax

    Time frame: Day 253

    Maximum observed plasma concentration (Cmax)

  2. Pharmacokinetics - AUC₀-t

    Time frame: Day 253

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)

  3. Pharmacokinetics - Tmax

    Time frame: Day 253

    Time to reach maximum observed plasma concentration (Tmax)

  4. Pharmacokinetics - t½

    Time frame: Day 253

    Terminal elimination half-life (t½)

  5. Immunogenicity - Anti-Drug Antibody (ADA)

    Time frame: Day 253

    Incidence and onset time of anti-drug antibody (ADA)

Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 20, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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