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

Last updated: February 19, 2026
Sponsor: Alnylam Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1/2

Condition

Diabetes Prevention

Obesity

Diabetes Mellitus, Type 2

Treatment

Placebo

ALN-4324

Clinical Study ID

NCT06845202
ALN-4324-001
2024-519005-35-00
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

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-glucosecotransporter 2 inhibitor (SGLT2i)

Exclusion

Exclusion Criteria:

Part A:

  • Has known human immunodeficiency virus (HIV) infection; or known current or chronichepatitis C virus or hepatitis B virus infection

Part B:

  • Receiving therapies for chronic weight management or antidiabetic medications otherthan metformin and SGLT2i

Note: other protocol defined inclusion/exclusion criteria apply

Study Design

Total Participants: 144
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1/2
Study Start date:
March 03, 2025
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Clinical Trial Site

    Mar del Plata 3430863, B B7600
    Argentina

    Site Not Available

  • Clinical Trial Site

    San Miguel de Tucumán 3836873, T T4000IHE
    Argentina

    Site Not Available

  • Clinical Trial Site

    Buenos Aires 3435910, C1061
    Argentina

    Site Not Available

  • Clinical Trial Site

    Vancouver 6173331, British Columbia 5909050 V5Y 3W2
    Canada

    Site Not Available

  • Clinical Trial Site

    Concord 5926526, Ontario 6093943 L4K 4M2
    Canada

    Site Not Available

  • Clinical Trial Site

    Laval, Quebec H7V 4B3
    Canada

    Site Not Available

  • Clinical Trial Site

    Laval 6050610, Quebec 6115047 H7V 4B3
    Canada

    Site Not Available

  • Clinical Trial Site

    Mount Royal 6077315, H3P 3P1
    Canada

    Active - Recruiting

  • Clinical Trial Site

    Santiago 3871336, RM 8320000
    Chile

    Site Not Available

  • Clinical Trial Site

    Essen 2928810, 45355
    Germany

    Site Not Available

  • Clinical Trial Site

    Gdansk 3099434, 80-546
    Poland

    Site Not Available

  • Clinical Trial Site

    Lublin 765876, 20-884
    Poland

    Site Not Available

  • Clinical Trial Site

    Tarnów 757026, 33-100
    Poland

    Site Not Available

  • Clinical Trial Site

    Warsaw 756135, 02-507
    Poland

    Site Not Available

  • Clinical Trial Site

    Montclair 5374232, California 5332921 91763
    United States

    Site Not Available

  • Clinical Trial Site

    Washington D.C. 4140963, District of Columbia 4138106 20009
    United States

    Site Not Available

  • Clinical Trial Site

    Miami 4164138, Florida 4155751 33126
    United States

    Active - Recruiting

  • Clinical Trial Site

    Overland Park 4276873, Kansas 4273857 66212
    United States

    Site Not Available

  • Clinical Trial Site

    Berlin 4500771, New Jersey 5101760 08009
    United States

    Site Not Available

  • Clinical Trial Site

    Monroe 4479946, North Carolina 4482348 28112
    United States

    Site Not Available

  • Clinical Trial Site

    Raleigh 4487042, North Carolina 4482348 27612
    United States

    Site Not Available

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