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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIkaria Bioscience Pty Ltd

About this trial

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)

Eligibility criteria

Qualifiers

Hypertension: seated BP ≤ 140/90 mm Hg; receiving ≤ 2 stable (≥ 4 weeks) agents limited to ACE inhibitors, angiotensin receptor blockers, calcium channel blockers, or thiazide ≤ 25 mg, or untreated

Dyslipidemia: stable use of lipid-lowering agents for dyslipidemia (LDL-C < 150 mg/dL, triglycerides < 300 mg/dL)

Osteoarthritis

Disqualifiers

self-reported or documented weight gain or loss >5% within 3 months prior to screening

use of GLP1R agonists within 6 months of screening

intolerance to GLP-1 medications in the past

use of non-GLP1R medications for weight loss within 3 months of screening

Trial design

Treatments tested in this trial

  • RN3161
  • Placebo Control
  • Tirzepatide

Treatment groups

104 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Ikaria Bioscience Pty Ltd

Lead sponsor

Shanghai Rona Therapeutics Co., Ltd.

Collaborator