A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
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)
Alnylam Pharmaceuticals
144 participants
Mar 3, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria7
- 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 Criteria4
- 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
Interventions
ALN-4324 will be administered subcutaneously (SC)
Placebo will be administered SC
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06845202