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A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Sponsor: Alnylam Pharmaceuticals
Summary
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
Official title: A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
144
Start Date
2025-03-03
Completion Date
2027-08-31
Last Updated
2026-05-14
Healthy Volunteers
Yes
Interventions
ALN-4324
ALN-4324 will be administered subcutaneously (SC)
Placebo
Placebo will be administered SC
Locations (22)
Clinical Trial Site
Montclair, California, United States
Clinical Trial Site
Washington D.C., District of Columbia, United States
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Marlton, New Jersey, United States
Clinical Trial Site
Monroe, North Carolina, United States
Clinical Trial Site
Dallas, Texas, United States
Clinical Trial Site
Dallas, Texas, United States
Clinical Trial Site
Buenos Aires, Argentina
Clinical Trial Site
Buenos Aires, Argentina
Clinical Trial Site
Buenos Aires, Argentina
Clinical Trial Site
San Miguel de Tucumán, Argentina
Clinical Trial Site
Concord, Canada
Clinical Trial Site
Mount Royal, Canada
Clinical Trial Site
Vancouver, Canada
Clinical Trial Site
Santiago, Chile
Clinical Trial Site
Santiago, Chile
Clinical Trial Site
Santiago, Chile
Clinical Trial Site
Essen, Germany
Clinical Trial Site
Gdansk, Poland
Clinical Trial Site
Tarnów, Poland
Clinical Trial Site
Warsaw, Poland
Clinical Trial Site
Wroclaw, Poland