Clinical trial

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

Active, not recruiting · Phase 1, Phase 2 · 6 countries · Registry ID NCT06845202

Active, not recruitingPhase 1, Phase 2Interventional

What this study is 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, PK, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years

SexAll

Healthy volunteersAccepted

ConditionObese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)

Full registry 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

Treatments and study arms

ALN-4324

Drug

ALN-4324 will be administered subcutaneously (SC)

Placebo

Drug

Placebo will be administered SC

Primary outcomes

Part A: Frequency of Adverse Events (AEs)Up to 9 months

Part B: Frequency of Adverse EventsUp to 12 months

Study locations

22 locations were listed when this page was built. The first 40 are shown.

Clinical Trial Site🇦🇷 Buenos Aires, Argentina