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Recruiting Phase 1, Phase 2 NCT06845202

A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM

Trial Parameters

Condition Obese or Overweight Healthy Volunteers
Sponsor Alnylam Pharmaceuticals
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 144
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-03-03
Completion 2027-08-31
Interventions
ALN-4324Placebo

Brief Summary

The purpose of this study is to: * evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 * evaluate the efficacy, safety, tolerability, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM

Eligibility Criteria

Inclusion Criteria: Part A: * Has a body mass index (BMI) of ≥27 kg/m\^2 and \<40 kg/m\^2 Part B: * Is an adult patient with a confirmed diagnosis of T2DM * Has a hemoglobin A1c (HbA1c) ≥7% to \<10.5% * Has a BMI of ≥25 kg/m\^2 and \<45 kg/m\^2 * Is on a stable dose of either metformin or metformin and a sodium-glucose cotransporter 2 inhibitor (SGLT2i) Exclusion Criteria: Part A: * Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection Part B: * Receiving therapies for chronic weight management or antidiabetic medications other than metformin and SGLT2i Note: other protocol defined inclusion/exclusion criteria apply

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