|
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
RECRUITINGPhase 1/2Sponsored by Alnylam Pharmaceuticals
Actively Recruiting
PhasePhase 1/2
SponsorAlnylam Pharmaceuticals
Started2025-03-03
Est. completion2027-08-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06845202
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
Age: 18 Years – 75 YearsHealthy 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
Conditions3
DiabetesObese or Overweight Healthy VolunteersType 2 Diabetes Mellitus (T2DM)
Locations1 site
Clinical Trial Site
Miami, Florida, 33126
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
Actively Recruiting
PhasePhase 1/2
SponsorAlnylam Pharmaceuticals
Started2025-03-03
Est. completion2027-08-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06845202