|

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
Locations7 sites

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)

Interventions1

Locations7 sites

Clinical Trial Site
Montclair, California, 91763
Clinical Trial Site
Washington D.C., District of Columbia, 20009
Clinical Trial Site
Miami, Florida, 33126
Clinical Trial Site
Marlton, New Jersey, 08053
Clinical Trial Site
Monroe, North Carolina, 28112

Find trials near these locations

Related trials

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.