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Tests treatment safety and results for Obesity &Amp; Overweight
Official title 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
ClinicalTrials.gov ID: NCT07245771
What this study is testing
What is RN3161?
RN3161 is an investigational medicine, being studied as a potential treatment for obesity & overweight.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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 (±...
- Hypertension: seated BP ≤ 140/90 mm Hg; receiving ≤ 2 stable (≥ 4 weeks) agents limited to ACE inhibitors, angiotensin receptor blockers, calcium...
- Dyslipidemia: stable use of lipid-lowering agents for dyslipidemia (LDL-C \< 150 mg/dL, triglycerides \< 300 mg/dL)
- Osteoarthritis
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.