RecruitingPhase 1Phase 2NCT07463846

A Study to Evaluate ALN-2232 in Participants With Obesity

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-2232 as Monotherapy and Co-initiated With Tirzepatide in Adult Participants With Obesity


Sponsor

Alnylam Pharmaceuticals

Enrollment

156 participants

Start Date

Mar 2, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to: * evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 in patients with obesity * evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • All Parts:
  • Has a body mass index (BMI) of ≥30 kg/m\^2 and <40 kg/m\^2
  • Has a hemoglobin A1c (HbA1c) <6.5%

Exclusion Criteria3

  • All Parts:
  • Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results
  • Receiving therapies for chronic weight management or antidiabetic medications

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Interventions

DRUGALN-2232

ALN-2232 will be administered subcutaneously (SC)

DRUGPlacebo

Placebo will be administered SC

DRUGTirzepatide

Tirzepatide will be administered SC


Locations(1)

Clinical Trial Site

Montreal, Canada

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NCT07463846


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