A Trial of HRS-5817 in Obese Participants

May 10, 2026 updated by: Atridia Pty Ltd.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6027
        • Linear

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: HRS-5817 dose level 1
Single dose of HRS-5817/placebo given subcutaneously (dose level 1)
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 1 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 2 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 3 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 4)
Experimental: Experimental: HRS-5817 dose level 2
Single dose of HRS-5817/placebo given subcutaneously (dose level 2)
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 1 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 2 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 3 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 4)
Experimental: HRS-5817 dose level 3
Single dose of HRS-5817/placebo given subcutaneously (dose level 3)
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 1 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 2 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 3 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 4)
Experimental: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 4)
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 1 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 2 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 3 )
Drug: HRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 4)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 253

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - Cmax
Time Frame: Day 253
Maximum observed plasma concentration (Cmax)
Day 253
Pharmacokinetics - AUC₀-t
Time Frame: Day 253
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)
Day 253
Pharmacokinetics - Tmax
Time Frame: Day 253
Time to reach maximum observed plasma concentration (Tmax)
Day 253
Pharmacokinetics - t½
Time Frame: Day 253
Terminal elimination half-life (t½)
Day 253
Immunogenicity - Anti-Drug Antibody (ADA)
Time Frame: Day 253
Incidence and onset time of anti-drug antibody (ADA)
Day 253

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atridia Pty Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-5817-103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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