RecruitingPhase 1Phase 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 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


Sponsor

Ikaria Bioscience Pty Ltd

Enrollment

104 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo Control, a drug called RN3161, and others for people with obesity & overweight. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRN3161

Investigational Product

DRUGPlacebo Control

0.9% normal saline SC injection

DRUGTirzepatide

In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide


Locations(1)

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT07245771


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