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RECRUITING
NCT07245771
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Nucleus Network Pty Ltd

Melbourne, Victoria, Australia