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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

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

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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