A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)
2 other identifiers
interventional
144
5 countries
20
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2025
Typical duration for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2025
CompletedFirst Posted
Study publicly available on registry
February 25, 2025
CompletedStudy Start
First participant enrolled
March 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
April 17, 2026
April 1, 2026
2.5 years
February 20, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part A: Frequency of Adverse Events (AEs)
Up to 9 months
Part B: Frequency of Adverse Events
Up to 12 months
Secondary Outcomes (7)
Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma
Predose and up to 3 days postdose
Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma
Predose and up to 3 days postdose
Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma
Predose and up to 3 days postdose
Part A: Fraction of ALN-4324 excreted in urine
Predose and up to 24 hours postdose (fe)
Part B: Change from Baseline in HbA1c
Baseline up to 6 months
- +2 more secondary outcomes
Study Arms (4)
Part A: ALN-4324
EXPERIMENTALParticipants will be administered a single dose of ALN-4324.
Part A: Placebo
PLACEBO COMPARATORParticipants will be administered a single dose of placebo.
Part B: ALN-4324
EXPERIMENTALParticipants will be administered multiple doses of ALN-4324
Part B: Placebo
PLACEBO COMPARATORParticipants will be administered multiple doses of placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Clinical Trial Site
Montclair, California, 91763, United States
Clinical Trial Site
Washington D.C., District of Columbia, 20009, United States
Clinical Trial Site
Miami, Florida, 33126, United States
Clinical Trial Site
Marlton, New Jersey, 08053, United States
Clinical Trial Site
Monroe, North Carolina, 28112, United States
Clinical Trial Site
Dallas, Texas, 75230, United States
Clinical Trial Site
Dallas, Texas, 75246, United States
Clinical Trial Site
Buenos Aires, C1060, Argentina
Clinical Trial Site
Buenos Aires, C1061AAE, Argentina
Clinical Trial Site
Buenos Aires, C1061, Argentina
Clinical Trial Site
San Miguel de Tucumán, T4000IHE, Argentina
Clinical Trial Site
Concord, L4K 4M2, Canada
Clinical Trial Site
Mount Royal, H3P 3P1, Canada
Clinical Trial Site
Vancouver, V5Y 3W2, Canada
Clinical Trial Site
Essen, 45355, Germany
Clinical Trial Site
Essen, 45355, Germany
Clinical Trial Site
Gdansk, 80-546, Poland
Clinical Trial Site
Tarnów, 33-100, Poland
Clinical Trial Site
Warsaw, 02-507, Poland
Clinical Trial Site
Wroclaw, 51-162, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Alnylam Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2025
First Posted
February 25, 2025
Study Start
March 3, 2025
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU. Access to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more. Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.