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
Study ID
NCT07245771
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Obesity &Amp; Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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)

Key Dates

Start date
Nov 4, 2025
Status verified
Nov 2025
Primary completion
Feb 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RN3161
    Investigational Product
  • Placebo Comparator: Placebo Control
    placebo control
  • Experimental: RN3161 and tirzepatide
    In Part 3, RN3161 co-administered with tirezepatide
  • Active Comparator: Placebo and tirzepatide
    In Part 3; Placebo co-administered with tirzepatide

Primary Outcome Measure

Blood Pressure [ Time Frame: 180 Days ]

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