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
Tirzepatide: In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* BMI:
Obesity: BMI ≥ 30 kg/m² for participants with no Asian ancestry and ≥ 27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with or without a weight-related comorbidity (excluding diabetes)
Overweight: BMI 27 to \<30 kg/m² for participants with no Asian ancestry and 23.0 to \<27.5 kg/m² for participants with Asian ancestry that has been stable (± 5%) for the previous 3 months (based on participant self-report or available medical records), with at least 1 weight-related comorbidity (excluding diabetes)
Weight-related comorbidities include a diagnosis of the following:
* 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
Exclusion Criteria:
* 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
* HbA1c \>6.5%
* diagnosis of significant liver disease
* history of malignancy or anaphylaxis
* use of any siRNA agent in the prior 12 months
Primary outcome measure(s)
Blood Pressure — 180 Days Number of participants with blood pressure changes measured in mmHg
ECG PR interval — 180 days Number of participants with change in PR interval measured as milliseconds
Physical Examination — 180 days 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 — 180 days 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
Adverse Events — 180 days Incidence of adverse events reported
Heart Rate — 180 days Number of participants with change in heart rate measured in beats per minute
ECG QRS Complex — 180 days Number of participants with changes in QRS complex measured in milliseconds
ECG QT interval — 180 days Number of participants with change in QT interval measured by Frederica method in milliseconds
Blood Hematology Laboratory — 180 days Number of participants with changes in blood hemoglobin, hematocrit, platelets, neutrophils and leukocytes measured in standard units
Blood Coagulation Laboratory — 180 days Number of participants with changes in plasma prothrombin time, activated partial thromboplastin time, and international normalized ratio measured in standard units
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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