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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
2026-03-31
Healthy Volunteers
Yes
Interventions
ALN-4324
ALN-4324 will be administered subcutaneously (SC)
Placebo
Placebo will be administered SC
Locations (2)
Clinical Trial Site
Miami, Florida, United States
Clinical Trial Site
Mount Royal, Canada