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Recruiting Phase 1/2 NCT06845202

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

Phase 1/2 – combined early trial
Conditions: Obese or Overweight Healthy Volunteers Type 2 Diabetes Mellitus (T2DM)

Sponsor: Alnylam Pharmaceuticals

trial.available_in: БГ
Overview
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
Who can participate
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
Interventions
ALN-4324
DRUG
Placebo
DRUG
Locations 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
Canada (3)
Clinical Trial Site
Concord
Clinical Trial Site
Mount Royal
Clinical Trial Site
Vancouver
NOT_YET_RECRUITING
Germany (2)
Clinical Trial Site
Essen
Clinical Trial Site
Essen
NOT_YET_RECRUITING
Poland (4)
Clinical Trial Site
Gdansk
Clinical Trial Site
Tarnów
NOT_YET_RECRUITING
Clinical Trial Site
Warsaw
Clinical Trial Site
Wroclaw
United States (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
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
03.03.2025
Completion date
31.08.2027
Registry ID
NCT06845202
Source
clinicaltrials.gov
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