NCT07238647

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1 obesity

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

January 16, 2026

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 16, 2025

Last Update Submit

January 15, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

    Number of participants with Adverse events and Serious adverse events

    Day 253

Secondary Outcomes (5)

  • Pharmacokinetics - Cmax

    Day 253

  • Pharmacokinetics - AUC₀-t

    Day 253

  • Pharmacokinetics - Tmax

    Day 253

  • Pharmacokinetics - t½

    Day 253

  • Immunogenicity - Anti-Drug Antibody (ADA)

    Day 253

Study Arms (4)

Experimental: HRS-5817 dose level 1

EXPERIMENTAL

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

Drug: HRS-5817

Experimental: HRS-5817 dose level 2

EXPERIMENTAL

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

Drug: HRS-5817

HRS-5817 dose level 3

EXPERIMENTAL

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

Drug: HRS-5817

HRS-5817

EXPERIMENTAL

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

Drug: HRS-5817

Interventions

HRS-5817DRUG

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

Experimental: HRS-5817 dose level 1

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear

Perth, Western Australia, 6027, Australia

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kathy You

CONTACT

61 02 9299 0433kathyyou@atridia.com

Eimy Minowa

CONTACT

61 432223162eimy.minowa@atridia.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: HRS-5817 subcutaneous administration
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

January 30, 2027

Last Updated

January 16, 2026

Record last verified: 2025-11

Locations

AU(1)