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ALN-APOC3

Phase 1

Dyslipidemia | Small molecule | Cardiovascular |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 16, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

ALN-APOC3 · 1 trial · 1 indication

Phase 1 1
NCT06784349ALN-APOC3 in Adult Participants With DyslipidemiaDyslipidemia
COMPLETED32 Analytics
PHASE1COMPLETED
ALN-APOC3 in Adult Participants With Dyslipidemia
DyslipidemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment Emergent Adverse Events (TEAEs)
Through Week 44
Severity of TEAEs
Through Week 44
Percent changes in fasting concentrations of High-Density Lipoprotein Cholesterol (HDL-C)
Baseline to week 24

Part B Only

Secondary Endpoints

Concentration of combined ALN-APOC3 and metabolites in plasma
Through Week 44
Urinary excretion of combined ALN-APOC3 and metabolites
Through 24 Hours, After Treatment
Percent change in fasting concentrations of APOC3
Baseline to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALN-APOC3 Ascending CohortsEXPERIMENTALPart A: Ascending Cohorts Randomized as described in the protocol May include optional cohorts
PlaceboPLACEBO_COMPARATORPart A and Part B: Randomized as described in the protocol
ALN-APOC3 low-doseEXPERIMENTALPart B: Parallel Arm Randomized as described in the protocol
ALN-APOC3 medium-doseEXPERIMENTALPart B: Parallel Arm Randomized as described in the protocol
ALN-APOC3 high-doseEXPERIMENTALPart B: Parallel Arm Randomized as described in the protocol

Interventions

NameTypeDescription
ALN-APOC3DRUGAdministered as per the protocol
Matching PlaceboDRUGAdministered as per the protocol
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: 1. Judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECG's) and laboratory safety testing, as defined in the protocol 2. Participants can enter the study under one of the following options, as def...

Countries:Moldova
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Frequently asked questions about ALN-APOC3

What is ALN-APOC3 used for?

ALN-APOC3 is an investigational small molecule being developed for the treatment of dyslipidemia, a condition characterized by abnormal levels of lipids in the blood. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing ALN-APOC3?

ALN-APOC3 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The drug is in Phase 1 clinical development for dyslipidemia.

What phase is ALN-APOC3 in?

ALN-APOC3 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. One Phase 1 clinical trial has been completed, and the drug is not currently in any active trials.

What clinical trials has ALN-APOC3 been in?

ALN-APOC3 has been studied in one completed Phase 1 clinical trial, identified as NCT06784349. This trial enrolled 32 adult participants with dyslipidemia in Moldova. The study was randomized, double-blind, and placebo-controlled, and it included healthy volunteers.

Is ALN-APOC3 the same as any other drug?

No alternative names for ALN-APOC3 have been reported. It is identified solely by its code name ALN-APOC3 and is being developed by Regeneron Pharmaceuticals for dyslipidemia.