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Набира участници Фаза 1/2 NCT06845202

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
Интервенции
ALN-4324
DRUG
Placebo
DRUG
Места на провеждане 20
Argentina (4)
Clinical Trial Site
Buenos Aires
Clinical Trial Site
Buenos Aires
NOT_YET_RECRUITING
Clinical Trial Site
Buenos Aires
Clinical Trial Site
San Miguel de Tucumán
Канада (3)
Clinical Trial Site
Concord
Clinical Trial Site
Mount Royal
Clinical Trial Site
Vancouver
NOT_YET_RECRUITING
Германия (2)
Clinical Trial Site
Essen
Clinical Trial Site
Essen
NOT_YET_RECRUITING
Полша (4)
Clinical Trial Site
Gdansk
Clinical Trial Site
Tarnów
NOT_YET_RECRUITING
Clinical Trial Site
Warsaw
Clinical Trial Site
Wroclaw
САЩ (7)
Clinical Trial Site
Dallas , Texas
Clinical Trial Site
Dallas , Texas
NOT_YET_RECRUITING
Clinical Trial Site
Marlton , New Jersey
Clinical Trial Site
Miami , Florida
Clinical Trial Site
Monroe , North Carolina
Clinical Trial Site
Montclair , California
Clinical Trial Site
Washington D.C. , District of Columbia
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
03.03.2025
Крайна дата
31.08.2027
Регистрационен номер
NCT06845202
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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