A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Running, not enrolling · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)
In brief
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
Key facts
- Study ID
- NCT06845202
- Run by
- Alnylam Pharmaceuticals
- People needed
- 105
- Starts
- 2025-03-03
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- 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 — 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
Full record on ClinicalTrials.gov
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