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

Eligibility criteria

Qualifiers

Has a body mass index (BMI) of ≥27 kg/m² and <40 kg/m²

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/m² and <45 kg/m²

Disqualifiers

Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection

Receiving therapies for chronic weight management or antidiabetic medications other than metformin and SGLT2i

Trial design

Treatments tested in this trial

  • ALN-4324
  • Placebo

Treatment groups

144 Participants
are divided into 4 treatment groups

Locations

22
Argentina
Clinical Trial SiteC1060, Buenos Aires Argentina
Clinical Trial SiteC1061AAE, Buenos Aires Argentina
Clinical Trial SiteC1061, Buenos Aires Argentina
Clinical Trial SiteT4000IHE, San Miguel de Tucumán Argentina

Sponsors and collaborators

Alnylam Pharmaceuticals

Lead sponsor