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

NCT06845202 · Alnylam Pharmaceuticals
In plain English

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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)
About this study
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 criteria
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
Study design
Enrollment target: 144 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-03-03
Estimated completion: 2027-08-31
Last updated: 2026-04-17
Interventions
Drug: ALN-4324Drug: Placebo
Primary outcomes
  • Part A: Frequency of Adverse Events (AEs) (Up to 9 months)
  • Part B: Frequency of Adverse Events (Up to 12 months)
Sponsor
Alnylam Pharmaceuticals · industry
Contacts & investigators
ContactAlnylam Clinical Trial Information Line · contact · clinicaltrials@alnylam.com · 1-877-ALNYLAM
ContactAlnylam Clinical Trial Information Line · contact · clinicaltrials@alnylam.com · 1-877-256-9526
InvestigatorMedical Director · study_director, Alnylam Pharmaceuticals
All locations (20)
Clinical Trial SiteRecruiting
Montclair, California, United States
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Washington D.C., District of Columbia, United States
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Miami, Florida, United States
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Marlton, New Jersey, United States
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Monroe, North Carolina, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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San Miguel de Tucumán, Argentina
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Concord, Canada
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Mount Royal, Canada
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Vancouver, Canada
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Essen, Germany
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Essen, Germany
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Gdansk, Poland
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Tarnów, Poland
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Warsaw, Poland
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Wroclaw, Poland