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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAlnylam Pharmaceuticals

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

Sponsors and collaborators