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

Ikaria

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Obesity &Amp; Overweight

Treatments: Drug: RN3161; Drug: Placebo Control; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07245771

RN3161-101

Details and patient eligibility

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)

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 4 patient groups, including a placebo group

RN3161

Experimental group

Description:

Investigational Product

Treatment:

Drug: RN3161

Placebo Control

Placebo Comparator group

Description:

placebo control

Treatment:

Drug: Placebo Control

RN3161 and tirzepatide

Experimental group

Description:

In Part 3, RN3161 co-administered with tirezepatide

Treatment:

Drug: Tirzepatide

Drug: RN3161

Placebo and tirzepatide

Active Comparator group

Description:

In Part 3; Placebo co-administered with tirzepatide

Treatment:

Drug: Tirzepatide

Drug: Placebo Control