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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: 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) Who Should NOT Join This Trial: Part A: - Has known human weakened immune system 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

ALN-4324

ALN-4324 will be administered subcutaneously (SC)

DRUG

Placebo

Placebo will be administered SC

Locations (2)

Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Mount Royal, Canada