ALN-APOC3 in Adult Participants With Dyslipidemia

Phase

Condition

Dyslipidemia

Treatment

ALN-APOC3

Matching Placebo

Clinical Study ID

NCT06784349

ALN-APOC3-hLP-2447

Ages 18-75
All Genders
Accepts Healthy Volunteers

Study Summary

This study is researching an experimental drug called ALN-APOC3 (called "study drug"). The study is focused on participants who have dyslipidemia (abnormal amounts of fats in the blood, including triglycerides and cholesterol), but who are otherwise healthy.

The aim of the study is to see how safe and effective the study drug is.

The study is looking at several other research questions, including:

What side effects may happen from taking the study drug
How much study drug is in the blood at different times
How the study drug changes lipid levels in the blood

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

Judged by the investigator to be in good health based on medical history, physicalexamination, vital signs, Electrocardiograms (ECG's) and laboratory safety testing,as defined in the protocol
Participants can enter the study under one of the following options, as defined inthe protocol:
Currently not taking statin and have not been on statin therapy for the 3months prior to screening, or
On a stable dose of statin, taken continuously for 3 months
Fasting triglycerides concentrations ≥100 and <500 mg/dL (1.13 to 5.65 mmol/L)during screening visit, as defined in the protocol
Fasting LDL-C ≥70 (1.81 mmol/L) if on stable statin therapy OR if not on statintreatment, as defined in the protocol

Exclusion

Key Exclusion Criteria:

History of clinically significant cardiovascular (other than dyslipidemia),respiratory, hepatic, renal, gastrointestinal, endocrine, hematological,psychiatric, or neurological disease, or any other concern, as assessed by theinvestigator that may confound the results of the study or poses an additional riskto the participant by study participation
Was hospitalized (ie, >24 hours) for any reason within 30 days of the screeningvisit
Is positive for Human Immunodeficiency Virus (HIV) or Hepatitis B surface Antigen (HBsAg) at the screening visit, as defined in the protocol
Is positive for hepatitis C antibody and positive for qualitative Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) test at the screening visit
Any malignancy, except for non-melanoma skin cancer or cervical/anus in-situ, thathave been resected with no evidence of metastatic disease for 3 years prior to thescreening visit

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design