GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 1, PHASE2

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

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

Lead sponsor

Ikaria Bioscience Pty Ltd

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

104

estimated

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Blood Pressure•ECG PR interval•Physical Examination

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07245771

Org study IDRN3161-101

Timeline

Milestones

Study start2025-11-04actual

Study first posted2025-11-24actual

Last update posted2025-11-24actual

Primary completion2027-02-15estimated

Study completion2027-08-15estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Cardiometabolic biomarkers

Glycemic / diabetes

1 endpoint

Other/protocol endpoint

Effect of RN3161 on plasma insulin

Time frame:180 days

concentration, descriptive

Cardiometabolic biomarkers

6 endpoints

Primary/protocol endpoint

Blood Pressure

Time frame:180 Days