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)
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
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
Parallel
RN3161
DrugInvestigational Product
Placebo Control
Drug0.9% normal saline SC injection
Tirzepatide
DrugIn Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide
Blood Pressure
Number of participants with blood pressure changes measured in mmHg
ECG PR interval
Number of participants with change in PR interval measured as milliseconds
Physical Examination
Number of participants with changes seen by physical examination of skin, lymph nodes, eyes, ears, throat, chest, abdomen, musculoskeletal system and nervous system
Blood Chemistry Laboratory
Number of participants with changes in blood levels of sodium, potassium, chloride, calcium magnesium, creatinine, bilirubin, phosphate, AST, ALT, alkaline phosphatase, glucose, albumin, urea in standard units
Plasma and Urine Pharmacokinetics
plasma and urine levels of RN3161
Presence of ADA
incidence of anti-drug antibodies in the plasma
Effect of RN3161 on plasma insulin
assess plasma insulin uU/mL
Assess RN3161 effect on plasma LDL
LDL-C in mg/dL
Effect of RN3161 on plasma HDL
HDL in mg/dL
Effect of RN3161 on plasma total cholesterol
total cholesterol in mg/dL
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Ikaria Bioscience Pty Ltd
Lead sponsor
Shanghai Rona Therapeutics Co., Ltd.
Collaborator
