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NCT06784349

ALN-APOC3 in Adult Participants With Dyslipidemia

NCT ID: NCT06784349

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-27

Study Completion Date

2026-02-25

Brief Summary

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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

Detailed Description

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Conditions

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Dyslipidemia

Keywords

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Lipids Triglycerides Cholesterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Part A: Sequential Part B: Parallel

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALN-APOC3 Ascending Cohorts

Part A: Ascending Cohorts Randomized as described in the protocol May include optional cohorts

Group Type EXPERIMENTAL

ALN-APOC3

Intervention Type DRUG

Administered as per the protocol

Matching Placebo

Intervention Type DRUG

Administered as per the protocol

Placebo

Part A and Part B:

Randomized as described in the protocol

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Administered as per the protocol

ALN-APOC3 low-dose

Part B: Parallel Arm Randomized as described in the protocol

Group Type EXPERIMENTAL

ALN-APOC3

Intervention Type DRUG

Administered as per the protocol

ALN-APOC3 medium-dose

Part B: Parallel Arm Randomized as described in the protocol

Group Type EXPERIMENTAL

ALN-APOC3

Intervention Type DRUG

Administered as per the protocol

ALN-APOC3 high-dose

Part B: Parallel Arm Randomized as described in the protocol

Group Type EXPERIMENTAL

ALN-APOC3

Intervention Type DRUG

Administered as per the protocol

Interventions

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ALN-APOC3

Administered as per the protocol

Intervention Type DRUG

Matching Placebo

Administered as per the protocol

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Arensia Exploratory Medicine at the Republican Clinical Hospital

Chisinau, , Moldova

Site Status

Countries

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Moldova

Other Identifiers

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ALN-APOC3-hLP-2447

Identifier Type: -

Identifier Source: org_study_id