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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
Sponsor: Ikaria Bioscience Pty Ltd
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)
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2025-11-04
Completion Date
2027-08-15
Last Updated
2025-11-24
Healthy Volunteers
Yes
Conditions
Interventions
RN3161
Investigational Product
Placebo Control
0.9% normal saline SC injection
Tirzepatide
In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide
Locations (1)
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia