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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2027-08-31

Brief Summary

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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

Detailed Description

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Conditions

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

Keywords

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siRNA RNAi therepeutic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part A: ALN-4324

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

Group Type EXPERIMENTAL

ALN-4324

Intervention Type DRUG

ALN-4324 will be administered subcutaneously (SC)

Part A: Placebo

Participants will be administered a single dose of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered SC

Part B: ALN-4324

Participants will be administered multiple doses of ALN-4324

Group Type EXPERIMENTAL

ALN-4324

Intervention Type DRUG

ALN-4324 will be administered subcutaneously (SC)

Part B: Placebo

Participants will be administered multiple doses of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered SC

Interventions

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ALN-4324

ALN-4324 will be administered subcutaneously (SC)

Intervention Type DRUG

Placebo

Placebo will be administered SC

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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