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Clinical Trials in Canada / NCT06845202
Active, not recruiting Phase 1/2

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

NCT06845202 · tracked via the Priya Life Science Canada tracker
Sponsor
Alnylam Pharmaceuticals
Phase
Phase 1/2
Started
2025-03-03
Last updated
2026-09-16

Condition(s) studied

Obese or Overweight Healthy VolunteersType 2 Diabetes Mellitus (T2DM)

Investigational drug(s) / intervention(s)

ALN-4324 →Placebo

ALN-4324: ALN-4324 will be administered subcutaneously (SC)

Placebo: Placebo will be administered SC

Study 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, PK, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: 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 Criteria: 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 Note: other protocol defined inclusion/exclusion criteria apply

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Clinical Trial Site Montclair California
Clinical Trial Site Washington D.C. District of Columbia
Clinical Trial Site Miami Florida
Clinical Trial Site Marlton New Jersey
Clinical Trial Site Monroe North Carolina
Clinical Trial Site Dallas Texas
Clinical Trial Site Dallas Texas
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

More Alnylam Pharmaceuticals trials in Canada

TRITON-CM: A Study to Evaluate Nucresiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy Recruiting
BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1) Active, not recruiting
A Study to Evaluate ALN-2232 in Participants With Obesity Recruiting
HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy Active, not recruiting
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT) Active, not recruiting

Other trials for the same condition

Goal-Directed Therapy to Reduce Kidney and Cardiovascular Risk in Diabetic Kidney Disease (GOLD-STANDARD) Recruiting
A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus Active, not recruiting
A Phase 1b Study of QX1206 in T2DM Patients With NAFLD Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06845202 on ClinicalTrials.gov ↗ ← All trials in Canada