NCT07245771RecruitingPhase 1/2
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 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
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 20 Sept 2025
- Start date
- 4 Nov 2025
- Primary completion date
- 15 Feb 2027
- Lead sponsor
- Ikaria Bioscience Pty Ltd
- Diseases
- Obesity
- NCT number
- NCT07245771
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 104
- From 4 Nov 2025 to the primary completion date, 15 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- self-reported or documented weight gain or loss \>5% within 3 months prior to screening
- intolerance to GLP-1 medications in the past
- use of non-GLP1R medications for weight loss within 3 months of screening
- use of any siRNA agent in the prior 12 months
Other illness
- diagnosis of significant liver disease
- history of malignancy or anaphylaxis
Lab values
- HbA1c \>6.5%
Other
- use of GLP1R agonists within 6 months of screening
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nucleus Network Pty Ltd Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.