ObesityEarly Phase 1NCT07238647
A Trial of HRS-5817 in Obese Participants
A Early Phase 1 study testing HRS-5817 in people with Obesity, run by Atridia Pty Ltd. at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obesity
- What is being tested?
- HRS-5817
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Jan 2026to 30 Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Obesity
- Being tested
- HRS-5817
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-5817Drug
Single dose of HRS-5817/placebo given subcutaneously (dose level 1 )
HRS-5817Drug
Single dose of HRS-5817/placebo given subcutaneously (dose level 2 )
HRS-5817Drug
Single dose of HRS-5817/placebo given subcutaneously (dose level 3 )
HRS-5817Drug
Single dose of HRS-5817/placebo given subcutaneously (dose level 4)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: HRS-5817 dose level 1 | Experimental | Single dose of HRS-5817/placebo given subcutaneously (dose level 1) Receives: Drug: HRS-5817 |
| Experimental: HRS-5817 dose level 2 | Experimental | Single dose of HRS-5817/placebo given subcutaneously (dose level 2) Receives: Drug: HRS-5817 |
| HRS-5817 dose level 3 | Experimental | Single dose of HRS-5817/placebo given subcutaneously (dose level 3) Receives: Drug: HRS-5817 |
| HRS-5817 | Experimental | Single dose of HRS-5817/placebo given subcutaneously (dose level 4) Receives: Drug: HRS-5817 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Number of participants with Adverse events and Serious adverse events
Measured: Day 253
Secondary outcomes (5)
Pharmacokinetics - Cmax
Maximum observed plasma concentration (Cmax)
Measured: Day 253
Pharmacokinetics - AUC₀-t
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)
Measured: Day 253
Pharmacokinetics - Tmax
Time to reach maximum observed plasma concentration (Tmax)
Measured: Day 253
Pharmacokinetics - t½
Terminal elimination half-life (t½)
Measured: Day 253
Immunogenicity - Anti-Drug Antibody (ADA)
Incidence and onset time of anti-drug antibody (ADA)
Measured: Day 253
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start5 Jan 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HRS-5817 subcutaneous administration
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238647
- Sponsor's protocol ID
- HRS-5817-103
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07238647
- Acronym / sponsor ID
- HRS-5817-103
- Conditions
- Obesity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- HRS-5817 subcutaneous administration
| Arm | Type | Receives |
|---|---|---|
| Experimental: HRS-5817 dose level 1 | Experimental | Drug: HRS-5817Single dose of HRS-5817/placebo given subcutaneously (dose level 1) |
| Experimental: HRS-5817 dose level 2 | Experimental | Drug: HRS-5817Single dose of HRS-5817/placebo given subcutaneously (dose level 2) |
| HRS-5817 dose level 3 | Experimental | Drug: HRS-5817Single dose of HRS-5817/placebo given subcutaneously (dose level 3) |
| HRS-5817 | Experimental | Drug: HRS-5817Single dose of HRS-5817/placebo given subcutaneously (dose level 4) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-5817Single dose of HRS-5817/placebo given subcutaneously (dose level 1 ) | Drug | Experimental: HRS-5817 dose level 1 |
| HRS-5817Single dose of HRS-5817/placebo given subcutaneously (dose level 2 ) | Drug | Experimental: HRS-5817 dose level 2 |
| HRS-5817Single dose of HRS-5817/placebo given subcutaneously (dose level 3 ) | Drug | HRS-5817 dose level 3 |
| HRS-5817Single dose of HRS-5817/placebo given subcutaneously (dose level 4) | Drug | HRS-5817 |
Primary outcome
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
5 secondary outcomes
Pharmacokinetics - Cmax
Time frame: Day 253
Pharmacokinetics - AUC₀-t
Time frame: Day 253
Pharmacokinetics - Tmax
Time frame: Day 253
Pharmacokinetics - t½
Time frame: Day 253
Immunogenicity - Anti-Drug Antibody (ADA)
Time frame: Day 253
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HRS-5817 in people with Obesity, run by Atridia Pty Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events (time frame: Day 253). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.