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Recruiting NCT07245771

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

Phase I / Phase II Interventional Obesity &Amp; Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RN3161, Placebo Control, Tirzepatide.
Who it may be relevant to
Registry conditions: Obesity &Amp; Overweight. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-Blind, Placebo-Controlled 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

Overview

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)

Interventions

  • Drug RN3161
    Investigational Product
  • Drug Placebo Control
    0.9% normal saline SC injection
  • Drug Tirzepatide
    In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide

Primary outcome measures

  • Blood Pressure [Time frame: 180 Days]
  • ECG PR interval [Time frame: 180 days]
  • Physical Examination [Time frame: 180 days]
  • Blood Chemistry Laboratory [Time frame: 180 days]
  • Adverse Events [Time frame: 180 days]
  • Heart Rate [Time frame: 180 days]
  • ECG QRS Complex [Time frame: 180 days]
  • ECG QT interval [Time frame: 180 days]
  • Blood Hematology Laboratory [Time frame: 180 days]
  • Blood Coagulation Laboratory [Time frame: 180 days]
Secondary outcome measures (2)
  • Plasma and Urine Pharmacokinetics [Time frame: 180 Days]
  • Presence of ADA [Time frame: 180 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Nucleus Network Pty Ltd — Melbourne

Identifiers

NCT: NCT07245771 · RN3161-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗