RecruitingPhase 1Phase 2NCT06845202

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)


Sponsor

Alnylam Pharmaceuticals

Enrollment

144 participants

Start Date

Mar 3, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called ALN-4324 in adults who are overweight or obese — either healthy individuals or those with Type 2 diabetes — to evaluate its safety and how well it may help with weight or blood sugar control. **You may be eligible if...** - You are overweight (BMI of 27 or above) but otherwise healthy (Part A), OR - You have Type 2 diabetes with a BMI of 25 or above, taking metformin (with or without an SGLT2 inhibitor), and your HbA1c is between 7% and 10.5% (Part B) **You may NOT be eligible if...** - You have HIV, hepatitis B, or hepatitis C - You are taking other diabetes or weight-loss drugs not specified in the study - You have significant liver disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALN-4324

ALN-4324 will be administered subcutaneously (SC)

DRUGPlacebo

Placebo will be administered SC


Locations(20)

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

Essen, Germany

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

View Full Details on ClinicalTrials.gov

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NCT06845202


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