NCT07245771

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Ikaria Bioscience Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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)

Conditions

• Obesity &Amp; Overweight

Interventions

Type	Name	Description
DRUG	RN3161	Investigational Product
DRUG	Placebo Control	0.9% normal saline SC injection
DRUG	Tirzepatide	In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide

Timeline

• Start date: 2025-11-04
• Primary completion: 2027-02-15
• Completion: 2027-08-15
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: Australia