Dyslipidemia
Conditions
Keywords
Lipids, Triglycerides, Cholesterol
Brief 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
Interventions
DRUGALN-APOC3
Administered as per the protocol
DRUGMatching Placebo
Administered as per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Part A: Sequential Part B: Parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Part A Only |
| Percent change in fasting concentrations of APOC3 | Baseline to Week 12 | — |
| Absolute change in fasting concentrations of APOC3 | Baseline to Week 12 | — |
| Percent change in fasting concentrations of HDL-C | Baseline to Week 12 | — |
| Absolute change in fasting concentrations of HDL-C | Baseline to Week 12 | — |
| Percent change in fasting concentrations of Low-Density Lipoprotein Cholesterol (LDL-C) | Baseline to Week 12 | — |
| Absolute change in fasting concentrations of LDL-C | Baseline to Week 12 | — |
| Percent change in fasting concentrations of LDL-C | Baseline to Week 24 | Part B Only |
| Percent change in fasting concentrations of Triglycerides (TG) | Baseline to Week 12 | — |
| Absolute change in fasting concentrations of TG | Baseline to Week 12 | — |
| Percent change in fasting concentrations of TG | Baseline to Week 24 | Part B Only |
| Percent change in fasting concentrations of non-HDL-C | Baseline to Week 12 | — |
| Absolute change in fasting concentrations of non-HDL-C | Baseline to Week 12 | — |
| Percent change in fasting concentrations of Apolipoprotein-B (APOB) | Baseline to Week 12 | — |
| Absolute change in fasting concentrations of APOB | Baseline to Week 12 | — |
| Percent change in fasting concentrations of APOB | Baseline to Week 24 | Part B Only |
Countries
Moldova
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed