Investigating ALN-APOC3 for treating dyslipidemia in adults
A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALN-APOC3 in Adult Participants With Dyslipidemia
This study is testing a new drug called ALN-APOC3 to see if it can safely help adults with abnormal blood lipid levels improve their health.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 1 site (Chisinau) |
| Trial ID | NCT06784349 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of an experimental drug called ALN-APOC3 in adults with dyslipidemia, characterized by abnormal lipid levels in the blood. The trial is divided into two parts, with participants in Part A being excluded from Part B. Researchers will monitor side effects, measure drug levels in the blood, and assess changes in lipid levels over time. Participants must meet specific health criteria and lipid level thresholds to qualify for the study.
Who should consider this trial
Good fit: Ideal candidates are adults with dyslipidemia who are either not on statin therapy or are on a stable dose of statins.
Not a fit: Patients with significant cardiovascular or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing dyslipidemia and improving lipid profiles in patients.
How similar studies have performed: Other studies have shown promise with similar lipid-modifying therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chisinau
- Arensia Exploratory Medicine at the Republican Clinical Hospital — Chisinau, Moldova, Republic of (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.