Active, not recruitingNCT07238647Updated May 12, 2026

A Trial of HRS-5817 in Obese Participants

An Early Phase 1 interventional study of HRS-5817 and HRS-5817 in Obesity, sponsored by Atridia Pty Ltd.. Active, not recruiting at 1 site in Australia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Atridia Pty Ltd. · Early Phase 1, Interventional, and Treatment

Phase: Early Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

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

Conditions studied

Obesity

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Obesity 6,296

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

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Lead sponsor

Atridia Pty Ltd. is the lead sponsor of 34 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

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

Study design

Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 40 participants (estimated)

Study arms

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

Interventions

DrugHRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 1 )
DrugHRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 2 )
DrugHRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 3 )
DrugHRS-5817
Single dose of HRS-5817/placebo given subcutaneously (dose level 4)

What researchers measure

Primary outcomes

Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Number of participants with Adverse events and Serious adverse events
Time frame: Day 253

Secondary outcomes

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

Study locations

1 site

Linear
Perth, Western Australia 6027, Australia

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07238647
Lead sponsor: Atridia Pty Ltd.
Responsible party: Sponsor
First posted: Nov 20, 2025
Start date: Jan 5, 2026
Primary completion: Jan 30, 2027 (estimated)
Completion: Jan 30, 2027 (estimated)
Last update: May 12, 2026

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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