Obesity &Amp; OverweightPhase 1/2NCT07245771
Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity
A Phase 1/2 study testing RN3161 and Tirzepatide in people with Obesity &Amp; Overweight, run by Ikaria Bioscience Pty Ltd at 1 site in Australia.
Trial summary
Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity &Amp; Overweight
- What is being tested?
- RN3161 and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Nov 2025to 15 Aug 2027
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI:
- Obesity: BMI ≥ 30 kg/m² for participants with no Asian ancestry and ≥ 27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with or without a weight-related comorbidity (excluding diabetes)
- Overweight: BMI 27 to <30 kg/m² for participants with no Asian ancestry and 23.0 to <27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with at least 1 weight-related comorbidity (excluding diabetes)
- Weight-related comorbidities include a diagnosis of the following:
- Hypertension: seated BP ≤ 140/90 mm Hg; receiving ≤ 2 stable (≥ 4 weeks) agents limited to ACE inhibitors, angiotensin receptor blockers, calcium channel blockers, or thiazide ≤ 25 mg, or untreated
- Dyslipidemia: stable use of lipid-lowering agents for dyslipidemia (LDL-C < 150 mg/dL, triglycerides < 300 mg/dL)
- Osteoarthritis
Who cannot join
- self-reported or documented weight gain or loss >5% within 3 months prior to screening
- use of GLP1R agonists within 6 months of screening
- intolerance to GLP-1 medications in the past
- use of non-GLP1R medications for weight loss within 3 months of screening
- HbA1c >6.5%
- diagnosis of significant liver disease
- history of malignancy or anaphylaxis
- use of any siRNA agent in the prior 12 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Nucleus Network Pty Ltd
Melbourne, Victoria, 3004
Philip Ryan, MD, 03 85939801, p.ryan@nucleusnetwork.com.au
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity
Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)
- Conditions
- Obesity &Amp; Overweight
- Being tested
- RN3161, Placebo Control, Tirzepatide
- Keywords
- obesity, overweight, healthy volunteers
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN3161Drug
Investigational Product
Placebo ControlDrug
0.9% normal saline SC injection
TirzepatideDrug
In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide
| Study group | Role | What they receive |
|---|---|---|
| RN3161 | Experimental | Investigational Product Receives: Drug: RN3161 |
| Placebo Control | Placebo comparator | placebo control Receives: Drug: Placebo Control |
| RN3161 and tirzepatide | Experimental | In Part 3, RN3161 co-administered with tirezepatide Receives: Drug: RN3161; Drug: Tirzepatide |
| Placebo and tirzepatide | Active comparator | In Part 3; Placebo co-administered with tirzepatide Receives: Drug: Placebo Control; Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Number of participants with blood pressure changes measured in mmHg
Measured: 180 Days
ECG PR interval
Number of participants with change in PR interval measured as milliseconds
Measured: 180 days
Physical Examination
Number of participants with changes seen by physical examination of skin, lymph nodes, eyes, ears, throat, chest, abdomen, musculoskeletal system and nervous system
Measured: 180 days
Blood Chemistry Laboratory
Number of participants with changes in blood levels of sodium, potassium, chloride, calcium magnesium, creatinine, bilirubin, phosphate, AST, ALT, alkaline phosphatase, glucose, albumin, urea in standard units
Measured: 180 days
Adverse Events
Incidence of adverse events reported
Measured: 180 days
Heart Rate
Number of participants with change in heart rate measured in beats per minute
Measured: 180 days
ECG QRS Complex
Number of participants with changes in QRS complex measured in milliseconds
Measured: 180 days
ECG QT interval
Number of participants with change in QT interval measured by Frederica method in milliseconds
Measured: 180 days
Blood Hematology Laboratory
Number of participants with changes in blood hemoglobin, hematocrit, platelets, neutrophils and leukocytes measured in standard units
Measured: 180 days
Blood Coagulation Laboratory
Number of participants with changes in plasma prothrombin time, activated partial thromboplastin time, and international normalized ratio measured in standard units
Measured: 180 days
Secondary outcomes (2)
Plasma and Urine Pharmacokinetics
plasma and urine levels of RN3161
Measured: 180 Days
Presence of ADA
incidence of anti-drug antibodies in the plasma
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start4 Nov 2025
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized to study drug or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ikaria Bioscience Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Rona Therapeutics Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Philip Ryan, MD, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245771
- Sponsor's protocol ID
- RN3161-101
- Status last verified
- Nov 2025
- First submitted
- 20 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan will be developed during study conduct.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT07245771
- Acronym / sponsor ID
- RN3161-101
- Conditions
- Obesity &Amp; Overweight
- Keywords
- obesity, overweight, healthy volunteers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Ikaria Bioscience Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Rona Therapeutics Co., Ltd.
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 24 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.
Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)
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
- randomized to study drug or placebo
| Arm | Type | Receives |
|---|---|---|
| RN3161 | Experimental | Drug: RN3161Investigational Product |
| Placebo Control | Placebo comparator | Drug: Placebo Controlplacebo control |
| RN3161 and tirzepatide | Experimental | Drug: RN3161, Drug: TirzepatideIn Part 3, RN3161 co-administered with tirezepatide |
| Placebo and tirzepatide | Active comparator | Drug: Placebo Control, Drug: TirzepatideIn Part 3; Placebo co-administered with tirzepatide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- BMI:
- Obesity: BMI ≥ 30 kg/m² for participants with no Asian ancestry and ≥ 27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with or without a weight-related comorbidity (excluding diabetes)
- Overweight: BMI 27 to <30 kg/m² for participants with no Asian ancestry and 23.0 to <27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with at least 1 weight-related comorbidity (excluding diabetes)
- Hypertension: seated BP ≤ 140/90 mm Hg; receiving ≤ 2 stable (≥ 4 weeks) agents limited to ACE inhibitors, angiotensin receptor blockers, calcium channel blockers, or thiazide ≤ 25 mg, or untreated
- Dyslipidemia: stable use of lipid-lowering agents for dyslipidemia (LDL-C < 150 mg/dL, triglycerides < 300 mg/dL)
Key exclusion criteria (8 listed)
- self-reported or documented weight gain or loss >5% within 3 months prior to screening
- use of GLP1R agonists within 6 months of screening
- intolerance to GLP-1 medications in the past
- use of non-GLP1R medications for weight loss within 3 months of screening
- HbA1c >6.5%
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 |
|---|---|---|
| RN3161Investigational Product | Drug | RN3161, RN3161 and tirzepatide |
| Placebo Control0.9% normal saline SC injection | Drug | Placebo Control, Placebo and tirzepatide |
| TirzepatideIn Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide | Drug | Placebo and tirzepatide, RN3161 and tirzepatide |
Primary outcome
Blood Pressure
Time frame: 180 Days
Number of participants with blood pressure changes measured in mmHg
ECG PR interval
Time frame: 180 days
Number of participants with change in PR interval measured as milliseconds
Physical Examination
Time frame: 180 days
Number of participants with changes seen by physical examination of skin, lymph nodes, eyes, ears, throat, chest, abdomen, musculoskeletal system and nervous system
Blood Chemistry Laboratory
Time frame: 180 days
Number of participants with changes in blood levels of sodium, potassium, chloride, calcium magnesium, creatinine, bilirubin, phosphate, AST, ALT, alkaline phosphatase, glucose, albumin, urea in standard units
Adverse Events
Time frame: 180 days
Incidence of adverse events reported
Heart Rate
Time frame: 180 days
Number of participants with change in heart rate measured in beats per minute
ECG QRS Complex
Time frame: 180 days
Number of participants with changes in QRS complex measured in milliseconds
ECG QT interval
Time frame: 180 days
Number of participants with change in QT interval measured by Frederica method in milliseconds
Blood Hematology Laboratory
Time frame: 180 days
Number of participants with changes in blood hemoglobin, hematocrit, platelets, neutrophils and leukocytes measured in standard units
Blood Coagulation Laboratory
Time frame: 180 days
Number of participants with changes in plasma prothrombin time, activated partial thromboplastin time, and international normalized ratio measured in standard units
2 secondary outcomes
Plasma and Urine Pharmacokinetics
Time frame: 180 Days
Presence of ADA
Time frame: 180 days
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 24 Nov 2025.
- Individual participant dataSharing planned: Yes. The plan will be developed during study conduct.
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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.
Philip Ryan, MD principal investigator
Nucleus Network Pty Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RN3161 and Tirzepatide in people with Obesity &Amp; Overweight, run by Ikaria Bioscience 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 180 Days). The study lists 10 primary outcomes in all. 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 24 Nov 2025.