A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Фаза 1/2 – комбинирано ранно изпитване
Заболявания:
Obese or Overweight Healthy Volunteers
Type 2 Diabetes Mellitus (T2DM)
Спонсор: Alnylam Pharmaceuticals
Налично на:
БГ
Обобщение
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
Кой може да участва
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