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

NCT06845202

Active Not RecruitingPhase 1, Phase 2

Sponsor: Alnylam Pharmaceuticals

Conditions: Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)

Interventions: ALN-4324, Placebo

Countries: United States, Argentina, Canada, Chile, Germany, Poland

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (22)
  • Montclair, California, United States
  • Washington D.C., District of Columbia, United States
  • Miami, Florida, United States
  • Marlton, New Jersey, United States
  • Monroe, North Carolina, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • San Miguel de Tucumán, Argentina
  • Concord, Canada
  • Mount Royal, Canada
  • Vancouver, Canada
  • Santiago, Chile
  • Santiago, Chile
  • Santiago, Chile
  • Essen, Germany
  • Gdansk, Poland
  • Tarnów, Poland
  • Warsaw, Poland
  • Wroclaw, Poland