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

NCT07245771 · Recruiting

Last updated 2026-05-28

This clinical trial is testing the safety and effects of a new drug called RN3161, alone and combined with tirzepatide, in adults who are overweight or have obesity, focusing on how it affects blood pressure.

Status Recruiting Currently enrolling participants.

Phase Phase1, Phase2

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 104 people Planned (estimated).

Who can join Ages 18–65 · all sexes Healthy volunteers accepted.

Timeline Started 2025-11 · est. completion 2027-08

Where 1 site · Australia

What this study is testing ClinicalTrials.gov NCT07245771 ↗

Description as written by the study sponsor.

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)

Treatments tested

RN3161 Drug

Investigational Product
Placebo Control Drug

0.9% normal saline SC injection
Tirzepatide Drug

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

Main thing measured	Blood Pressure
Sponsor	Ikaria Bioscience Pty Ltd
Conditions studied	Obesity &Amp; Overweight
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07245771 ↗