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

Recruiting nowPhase 1, Phase 2Interventional

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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionObesity &Amp; Overweight

Full registry criteria

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

Treatments and study arms

RN3161

Drug

Investigational Product

Placebo Control

Drug

0.9% normal saline SC injection

Tirzepatide

Drug

In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide

Primary outcomes

Blood Pressure180 Days

Number of participants with blood pressure changes measured in mmHg

ECG PR interval180 days

Number of participants with change in PR interval measured as milliseconds

Physical Examination180 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 Laboratory180 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 Events180 days

Incidence of adverse events reported

Heart Rate180 days

Number of participants with change in heart rate measured in beats per minute

ECG QRS Complex180 days

Number of participants with changes in QRS complex measured in milliseconds

ECG QT interval180 days

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.

Nucleus Network Pty Ltd🇦🇺 Melbourne, Victoria, Australia
Philip Ryan, MDContact