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

Alnylam Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Drug: ALN-4324; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06845202

2024-519005-35-00 (EU Trial (CTIS) Number)

ALN-4324-001

Details and patient eligibility

About

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

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 4 patient groups, including a placebo group

Part A: ALN-4324

Experimental group

Description:

Participants will be administered a single dose of ALN-4324.

Treatment:

Drug: ALN-4324

Part A: Placebo

Placebo Comparator group

Description:

Participants will be administered a single dose of placebo.

Treatment:

Drug: Placebo

Part B: ALN-4324

Experimental group

Description:

Participants will be administered multiple doses of ALN-4324

Treatment:

Drug: ALN-4324

Part B: Placebo

Placebo Comparator group

Description:

Participants will be administered multiple doses of placebo

Treatment:

Drug: Placebo