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

Phase 2Active Not RecruitingNCT06845202

Alnylam Pharmaceuticals105 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

105

Conditions

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

Interventions

ALN-4324DRUG

ALN-4324 will be administered subcutaneously (SC)

PlaceboDRUG

Placebo will be administered SC

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Clinical Trial Site

Montclair, California, United States

Clinical Trial Site

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Part A: Frequency of Adverse Events (AEs)

Time frame: Up to 9 months

Part B: Frequency of Adverse Events

Time frame: Up to 12 months

Secondary Outcomes

Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma

Time frame: Predose and up to 3 days postdose

Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma

Time frame: Predose and up to 3 days postdose

Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma

Time frame: Predose and up to 3 days postdose

Part A: Fraction of ALN-4324 excreted in urine

Time frame: Predose and up to 24 hours postdose (fe)

Part B: Change from Baseline in HbA1c

Time frame: Baseline up to 6 months

Part B: Response to Glucose Tolerance Test

Time frame: Predose and up to 2 hours postdose

Part B: Concentrations of ALN-4324 in Plasma

Time frame: Predose and up to 4 hours postdose

Data from ClinicalTrials.gov

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