ALN-APOC3 in Adult Participants With Dyslipidemia

Launched by REGENERON PHARMACEUTICALS · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying an experimental drug called ALN-APOC3, which is being tested in adults who have dyslipidemia, a condition that means there are unhealthy levels of fats like cholesterol and triglycerides in the blood. The main goal of the trial is to find out if this study drug is safe and effective. Researchers will also look at any side effects that may occur, how the drug levels change in the blood over time, and how it affects lipid levels.

To join the study, participants must be generally healthy and meet certain criteria, such as having fasting triglyceride levels between 100 and 500 mg/dL, and certain cholesterol levels based on whether they are taking cholesterol-lowering medication called statins. The study is open to adults aged 18 to 80, and both men and women can participate. Those who take part will undergo a thorough health check and will be monitored throughout the study to see how they respond to the drug. It’s important for potential participants to understand the eligibility requirements and any risks involved before deciding to join.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Judged by the investigator to be in 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 defined in the protocol:
• • 1. Currently not taking statin and have not been on statin therapy for the 3 months prior to screening, or
• • 2. On a stable dose of statin, taken continuously for 3 months
• • 3. Fasting triglycerides concentrations ≥100 and \<500 mg/dL (1.13 to 5.65 mmol/L) during screening visit, as defined in the protocol
• • 4. Fasting LDL-C ≥70 (1.81 mmol/L) if on stable statin therapy OR if not on statin treatment, as defined in the protocol
• Key Exclusion Criteria:
• • 1. 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 the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
• • 2. Was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit
• • 3. Is positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) at the screening visit, as defined in the protocol
• • 4. Is positive for hepatitis C antibody and positive for qualitative hepatitis c virus (HCV) ribonucleic acid (RNA) test at the screening visit
• • 5. Any malignancy, except for non-melanoma skin cancer or cervical/anus in-situ, that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit
• • NOTE: Other protocol defined inclusion/exclusion criteria apply