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

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

Recruiting
18-75 years
All
Phase 1/2

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Overview

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

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

Study details
    Obese or Overweight Healthy Volunteers
    Type 2 Diabetes Mellitus (T2DM)

NCT06845202

Alnylam Pharmaceuticals

13 May 2026

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