ALN-APOC3 in Adult Participants With Dyslipidemia (NCT06784349) | Clinical Trial Compass
CompletedPhase 1
ALN-APOC3 in Adult Participants With Dyslipidemia
Moldova32 participantsStarted 2025-01-27
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. Participants can enter the study under one of the following options, as defined in the protocol:
. Currently not taking statin and have not been on statin therapy for the 3 months 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 statin treatment, as defined in the protocol
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Through Week 44
2
Severity of TEAEs
Timeframe: Through Week 44
3
Percent changes in fasting concentrations of High-Density Lipoprotein Cholesterol (HDL-C)
. 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
. Was hospitalized (ie, \>24 hours) for any reason within 30 days of the screening visit
. 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, that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit