Actively Recruiting
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
Led by Ikaria Bioscience Pty Ltd · Updated on 2025-11-24
104
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
Sponsors
I
Ikaria Bioscience Pty Ltd
Lead Sponsor
S
Shanghai Rona Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Obesity: BMI �30 kg/m for non-Asian ancestry or �327.5 kg/m for Asian ancestry, stable within �b15% for 3 months
- Overweight: BMI 27 to <30 kg/m for non-Asian ancestry or 23 to <27.5 kg/m for Asian ancestry, stable within �b15% for 3 months
- At least one weight-related comorbidity excluding diabetes, such as hypertension (controlled with up to 2 agents or untreated), dyslipidemia (controlled with lipid-lowering agents), or osteoarthritis
You will not qualify if you...
- Weight gain or loss greater than 5% within 3 months before screening
- Use of GLP-1 receptor agonists within 6 months before screening
- Past intolerance to GLP-1 medications
- Use of non-GLP-1 receptor medications for weight loss within 3 months before screening
- HbA1c greater than 6.5%
- Significant liver disease
- History of cancer or anaphylaxis
- Use of any siRNA agent within the prior 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia, 3004
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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