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RECRUITING
NCT06845202
PHASE1/PHASE2

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

Sponsor: Alnylam Pharmaceuticals

View on ClinicalTrials.gov

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

DRUG

ALN-4324

ALN-4324 will be administered subcutaneously (SC)

DRUG

Placebo

Placebo will be administered SC

Locations (2)

Clinical Trial Site

Miami, Florida, United States

Clinical Trial Site

Mount Royal, Canada