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
Phase 1Phase 2Interventional Study
Obesity &Amp; Overweight
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
104 (estimated)
Sponsor
Ikaria Bioscience Pty Ltd · Industry
Who this trial is looking for
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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)
Trial Locations
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Status
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 c…
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
Contacts
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