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Completed

NCT Number: NCT06784349

ALN-APOC3 in Adult Participants With Dyslipidemia

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Arensia Exploratory Medicine at the Republican Clinical Hospital

Chisinau, 2025, Moldova

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key 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

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 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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Treatment and study plan

ALN-APOC3

Drug

Administered as per the protocol

Matching Placebo

Drug

Administered as per the protocol

Primary outcomes

  1. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Through Week 44

  2. Severity of TEAEs

    Time frame: Through Week 44

  3. Percent changes in fasting concentrations of High-Density Lipoprotein Cholesterol (HDL-C)

    Time frame: Baseline to week 24

    Part B Only

Secondary outcomes

  1. Concentration of combined ALN-APOC3 and metabolites in plasma

    Time frame: Through Week 44

  2. Urinary excretion of combined ALN-APOC3 and metabolites

    Time frame: Through 24 Hours, After Treatment

    Part A Only

  3. Percent change in fasting concentrations of APOC3

    Time frame: Baseline to Week 12

  4. Absolute change in fasting concentrations of APOC3

    Time frame: Baseline to Week 12

  5. Percent change in fasting concentrations of APOC3

    Time frame: Baseline to Week 24

    Part B Only

  6. Absolute change in fasting concentrations of APOC3

    Time frame: Baseline to Week 24

    Part B Only

  7. Percent change in fasting concentrations of HDL-C

    Time frame: Baseline to Week 12

  8. Absolute change in fasting concentrations of HDL-C

    Time frame: Baseline to Week 12

  9. Absolute change in fasting concentrations of HDL-C

    Time frame: Baseline to Week 24

    Part B Only

  10. Percent change in fasting concentrations of Low-Density Lipoprotein Cholesterol (LDL-C)

    Time frame: Baseline to Week 12

  11. Absolute change in fasting concentrations of LDL-C

    Time frame: Baseline to Week 12

  12. Percent change in fasting concentrations of LDL-C

    Time frame: Baseline to Week 24

    Part B Only

  13. Absolute change in fasting concentrations of LDL-C

    Time frame: Baseline to Week 24

    Part B Only

  14. Percent change in fasting concentrations of Triglycerides (TG)

    Time frame: Baseline to Week 12

  15. Absolute change in fasting concentrations of TG

    Time frame: Baseline to Week 12

  16. Percent change in fasting concentrations of TG

    Time frame: Baseline to Week 24

    Part B Only

  17. Absolute change in fasting concentrations of TG

    Time frame: Baseline to Week 24

    Part B Only

  18. Percent change in fasting concentrations of non-HDL-C

    Time frame: Baseline to Week 12

  19. Absolute change in fasting concentrations of non-HDL-C

    Time frame: Baseline to Week 12

  20. Percent change in fasting concentrations of non-HDL-C

    Time frame: Baseline to Week 24

    Part B Only

  21. Absolute change in fasting concentrations of non-HDL-C

    Time frame: Baseline to Week 24

    Part B Only

  22. Percent change in fasting concentrations of Apolipoprotein-B (APOB)

    Time frame: Baseline to Week 12

  23. Absolute change in fasting concentrations of APOB

    Time frame: Baseline to Week 12

  24. Percent change in fasting concentrations of APOB

    Time frame: Baseline to Week 24

    Part B Only

  25. Absolute change in fasting concentrations of APOB

    Time frame: Baseline to Week 24

    Part B Only

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALN-APOC3 in Adult Participants With Dyslipidemia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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