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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

NCT07245771 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-11-24

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shanghai Rona Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • Ikaria Bioscience Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Philip Ryan, MD · Nucleus Network Pty Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2027-02-15
Completion
2027-08-15

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07245771 on ClinicalTrials.gov