LivingGLP1
Study S001388

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

Registration

Registration
NCT07245771
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE1; PHASE2
Masking
QUADRUPLE
Status
RECRUITING
Enrollment
104
Start
2025-11-04
Primary completion
2027-02-15
Lead sponsor
Ikaria Bioscience Pty Ltd
Conditions
Obesity &Amp; Overweight
Interventions
DRUG:RN3161; DRUG:Placebo Control; DRUG:Tirzepatide
Results posted
FALSE
Individual participant data sharing
YES

Registered primary outcomes

  • Blood Pressure [180 Days]
  • ECG PR interval [180 days]
  • Physical Examination [180 days]
  • Blood Chemistry Laboratory [180 days]
  • Adverse Events [180 days]
  • Heart Rate [180 days]
  • ECG QRS Complex [180 days]
  • ECG QT interval [180 days]
  • Blood Hematology Laboratory [180 days]
  • Blood Coagulation Laboratory [180 days]

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