Clinical trial
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
Recruiting now · Phase 1, Phase 2 · 1 countries · Registry ID NCT07245771
What this study is about
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)
Basic eligibility
Full registry criteria
Treatments and study arms
RN3161
Investigational Product
Placebo Control
0.9% normal saline SC injection
Tirzepatide
In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide
Primary outcomes
Number of participants with blood pressure changes measured in mmHg
Number of participants with change in PR interval measured as milliseconds
Number of participants with changes seen by physical examination of skin, lymph nodes, eyes, ears, throat, chest, abdomen, musculoskeletal system and nervous system
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
Incidence of adverse events reported
Number of participants with change in heart rate measured in beats per minute
Number of participants with changes in QRS complex measured in milliseconds
Number of participants with change in QT interval measured by Frederica method in milliseconds
Study locations
1 locations were listed when this page was built. The first 40 are shown.