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DyslipidemiaPhase 1NCT06784349

ALN-APOC3 in Adult Participants With Dyslipidemia

A Phase 1 study testing ALN-APOC3 in people with Dyslipidemia, run by Regeneron Pharmaceuticals at 1 site in Moldova.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Dyslipidemia
What is being tested?
ALN-APOC3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteMoldova
Study dates
27 Jan 2025to 25 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Moldova1 site

  • Arensia Exploratory Medicine at the Republican Clinical Hospital

    Chisinau, 2025

Other trials in Moldova

About this study

Official 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

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
Conditions
Dyslipidemia
Being tested
ALN-APOC3, Matching Placebo
Keywords
Lipids, Triglycerides, Cholesterol
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALN-APOC3Drug

    Administered as per the protocol

  • Matching PlaceboDrug

    Administered as per the protocol

Study groups in NCT06784349
Study groupRoleWhat they receive
ALN-APOC3 Ascending CohortsExperimentalPart A: Ascending Cohorts Randomized as described in the protocol May include optional cohorts
Receives: Drug: ALN-APOC3; Drug: Matching Placebo
PlaceboPlacebo comparatorPart A and Part B: Randomized as described in the protocol
Receives: Drug: Matching Placebo
ALN-APOC3 low-doseExperimentalPart B: Parallel Arm Randomized as described in the protocol
Receives: Drug: ALN-APOC3
ALN-APOC3 medium-doseExperimentalPart B: Parallel Arm Randomized as described in the protocol
Receives: Drug: ALN-APOC3
ALN-APOC3 high-doseExperimentalPart B: Parallel Arm Randomized as described in the protocol
Receives: Drug: ALN-APOC3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Measured: Through Week 44

  2. Severity of TEAEs

    Measured: Through Week 44

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

    Part B Only

    Measured: Baseline to week 24

Secondary outcomes (25)

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

    Measured: Through Week 44

  2. Urinary excretion of combined ALN-APOC3 and metabolites

    Part A Only

    Measured: Through 24 Hours, After Treatment

  3. Percent change in fasting concentrations of APOC3

    Measured: Baseline to Week 12

  4. Absolute change in fasting concentrations of APOC3

    Measured: Baseline to Week 12

  5. Percent change in fasting concentrations of APOC3

    Part B Only

    Measured: Baseline to Week 24

  6. Absolute change in fasting concentrations of APOC3

    Part B Only

    Measured: Baseline to Week 24

  7. Percent change in fasting concentrations of HDL-C

    Measured: Baseline to Week 12

  8. Absolute change in fasting concentrations of HDL-C

    Measured: Baseline to Week 12

  9. Absolute change in fasting concentrations of HDL-C

    Part B Only

    Measured: Baseline to Week 24

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

    Measured: Baseline to Week 12

  11. Absolute change in fasting concentrations of LDL-C

    Measured: Baseline to Week 12

  12. Percent change in fasting concentrations of LDL-C

    Part B Only

    Measured: Baseline to Week 24

  13. Absolute change in fasting concentrations of LDL-C

    Part B Only

    Measured: Baseline to Week 24

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

    Measured: Baseline to Week 12

  15. Absolute change in fasting concentrations of TG

    Measured: Baseline to Week 12

  16. Percent change in fasting concentrations of TG

    Part B Only

    Measured: Baseline to Week 24

  17. Absolute change in fasting concentrations of TG

    Part B Only

    Measured: Baseline to Week 24

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

    Measured: Baseline to Week 12

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

    Measured: Baseline to Week 12

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

    Part B Only

    Measured: Baseline to Week 24

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

    Part B Only

    Measured: Baseline to Week 24

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

    Measured: Baseline to Week 12

  23. Absolute change in fasting concentrations of APOB

    Measured: Baseline to Week 12

  24. Percent change in fasting concentrations of APOB

    Part B Only

    Measured: Baseline to Week 24

  25. Absolute change in fasting concentrations of APOB

    Part B Only

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start27 Jan 2025
  3. Primary completion25 Feb 2026
  4. Study completion25 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Part A: Sequential Part B: Parallel
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06784349
Sponsor's protocol ID
ALN-APOC3-hLP-2447
Status last verified
Mar 2026
First submitted
3 Dec 2024
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALN-APOC3 in people with Dyslipidemia, run by Regeneron Pharmaceuticals at 1 site in Moldova.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Emergent Adverse Events (TEAEs) (time frame: Through Week 44). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06784349.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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