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

Sponsored by Alnylam Pharmaceuticals

About this trial

Last updated 4 days ago

Study ID

ALN-4324-001

Status

Recruiting

Type

Interventional

Phase

Phase 1/Phase 2

Placebo

Yes

Accepting

18-75 Years
18 to 75 Years
All
All

Trial Timing

Started a year ago

What is this trial about?

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

What are the participation requirements?

Yes

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)

No

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

Locations

Location

Status

Recruiting
Recruiting

For more information, view the full study details:

NCT06845202