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ALN-4324

Phase 2

Type 2 Diabetes Mellitus (T2DM) | Small molecule | Metabolic |Alnylam Pharmaceuticals, Inc.|Last Updated: Aug 14, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

ALN-4324 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT07465224A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)
RECRUITING24 Analytics
PHASE2RECRUITING
A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change from Baseline in M-value
Baseline up to Month 3

M-value is measured as the glucose infusion rate at steady state

Part A: Frequency of Adverse Events (AEs)
Up to 9 months
Part B: Frequency of Adverse Events
Up to 12 months

Secondary Endpoints

Frequency of Adverse Events (AEs)
Up to Month 9
Change from Baseline in M/I
Baseline up to Month 6
Change from Baseline in M-value
Baseline up to Month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALN-4324EXPERIMENTALParticipants will be administered a single dose of ALN-4324.
PlaceboPLACEBO_COMPARATORParticipants will be administered a single dose of placebo.
Part A: ALN-4324EXPERIMENTALParticipants will be administered a single dose of ALN-4324.
Part A: PlaceboPLACEBO_COMPARATORParticipants will be administered a single dose of placebo.
Part B: ALN-4324EXPERIMENTALParticipants will be administered multiple doses of ALN-4324
Part B: PlaceboPLACEBO_COMPARATORParticipants will be administered multiple doses of placebo

Interventions

NameTypeDescription
ALN-4324DRUGALN-4324 will be administered subcutaneously (SC).
PlaceboDRUGPlacebo will be administered SC.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Is an adult patient with a confirmed diagnosis of T2DM * Has a body mass index (BMI) of ≥23 kg/m\^2 to ≤39.9 kg/m\^2 * Has a hemoglobin A1c (HbA1c) ≥6.5% to \<10.5% * Is on a stable dose of metformin, sodium-glucose cotransporter 2 inhibitor (SGLT2i), or dipeptidyl peptidase-4...

Countries:United StatesArgentinaCanadaChileGermanyPoland
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT06845202lastUpdatePostDate: changed
LOWAug 14, 2026NCT06845202lastUpdatePostDate: changed
LOWAug 12, 2026NCT07465224lastUpdatePostDate: changed
LOWAug 12, 2026NCT07465224lastUpdatePostDate: changed
HIGHJul 24, 2026NCT07465224Enrollment: 40 → 24
HIGHJul 24, 2026NCT06845202Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJul 24, 2026NCT07465224Enrollment: 40 → 24
HIGHJul 24, 2026NCT06845202Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 12, 2026NCT07465224lastUpdatePostDate: changed
LOWJun 12, 2026NCT06845202lastUpdatePostDate: changed
LOWJun 12, 2026NCT07465224lastUpdatePostDate: changed
LOWJun 12, 2026NCT06845202lastUpdatePostDate: changed

Frequently asked questions about ALN-4324

What is ALN-4324 used for?

ALN-4324 is an investigational drug being developed for Type 2 Diabetes Mellitus (T2DM) and is also studied in obese or overweight healthy volunteers. It is in Phase 1 clinical development for these metabolic conditions.

Who makes ALN-4324?

ALN-4324 is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol ALNY.

What phase is ALN-4324 in?

ALN-4324 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials.

What clinical trials is ALN-4324 in?

ALN-4324 is being evaluated in a Phase 1 trial with the identifier NCT06845202. This study is active but not recruiting and enrolls overweight to obese healthy volunteers and patients with Type 2 Diabetes Mellitus.

Is ALN-4324 being studied in patients with Type 2 Diabetes Mellitus?

Yes, ALN-4324 is being studied in patients with Type 2 Diabetes Mellitus (T2DM). The Phase 1 trial NCT06845202 includes overweight to obese patients with T2DM, and the study is being conducted in multiple countries.

What is the design of the ALN-4324 Phase 1 trial?

The ALN-4324 Phase 1 trial, NCT06845202, is a randomized, double-blind, placebo-controlled study. It enrolls 105 participants who are overweight to obese healthy volunteers or patients with Type 2 Diabetes Mellitus.