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Active, not recruitingNCT06452771Updated Feb 20, 2026

A First In Human (FIH) Study to Learn if Different Doses of ALN-ANG3 Are Safe and Well Tolerated in Healthy Adults

A Phase 1 interventional study of ALN-ANG3 and Placebo (PB) in Healthy Volunteers With Hyperlipidemia, sponsored by Regeneron Pharmaceuticals. Active, not recruiting at 1 site in New Zealand. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study is researching an experimental drug called ALN-ANG3 (called "study drug"). The study is focused on healthy participants with an elevated level of blood lipids (eg, cholesterol and triglycerides).

The aim of the study is to see how safe and tolerable the study drug is in healthy adult participants.

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
  • Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
Read the detailed description

This is a 2-Part study. Participants in Part A are excluded from participation in Part B

02

Conditions studied

  • Healthy Volunteers With Hyperlipidemia

Keywords

  • Elevated levels of blood lipids and cholesterol
  • Small interfering RNA (siRNA)
  • Angiopoietin-like protein 3 (ANGPTL3)
  • Liver cells protein
03

In context

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  1. Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram's (ECG's) performed at screening and/or prior to administration of initial dose of study drug
  2. Has fasting triglyceride (TG) levels >=100 and \<500 mg/dL (1.13-5.65 mmol/L), defined as hyperlipidemia, and fasting Low-Density Lipoprotein (LDL-C) >=70 and \<=300 mg/dL (1.81-7.76 mmol/L), defined as hyperlipidemia, during screening visit. Testing may be repeated once during the screening period in case the visit 1 levels fall outside of the required range
  3. Has a body mass index between 18 and 35 kg/m\^2, inclusive, at screening visit

Key Exclusion Criteria:

  1. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological or other disease, 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. 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
  4. Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
  5. With the exception of stable (approximately 3 months at same dose level) statin use, any prescription medication for approximately 2 weeks or 5 half-lives, whichever is longer, prior to first administration of the study drug through the End Of Study (EOS). Non-prescription medications and nutritional supplements are permitted after alignment of investigator and sponsor on their use
  6. Using the Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology (CKD-EPI) equation, has an estimated Glomerular Filtration Rate (GFR) of \<60 mL/min/1.73m2 at the screening visit, as defined in the protocol
  7. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) with clinically significant abnormality in the opinion of investigator or ≥1.5× Upper Limit of Normal (ULN) range at screening or day -1 visits
  8. Is positive for Human Immunodeficiency Virus (HIV) or Hepatitis B surface Antigen (HBsAg) at the screening visit. Evidence of prior hepatitis B immunization or prior resolved hepatitis B infection is not an exclusion
  9. Is positive for hepatitis C antibody and positive for qualitative (ie, detected or not detected) Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) test at the screening visit

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Part A: Cohorts

    Drug: ALN-ANG3 · Drug: Placebo (PB)

  • Experimental
    Part B: Cohorts

    Drug: ALN-ANG3 · Drug: Placebo (PB)

Interventions

  • DrugALN-ANG3

    Administered per the protocol

  • DrugPlacebo (PB)

    Administered per the protocol

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs)

    In participants treated with ALN-ANG3 or placebo (PBO)

    Time frame: Up to Approximately 323 Days

  2. Severity of TEAEs

    In participants treated with ALN-ANG3 or PBO

    Time frame: Up to Approximately 323 Days

Secondary outcomes

  1. Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma

    Part A

    Time frame: Within 3 Days Post Dose up to Approximately 323 Days

  2. Concentration of combined ALN-ANG3 and its (N-1)3^1 metabolite in plasma

    Part B

    Time frame: Prior to Each Dose up to Approximately 323 Days

07

Study locations

1 site
  • New Zealand Clinical Research
    Christchurch, Canterbury 8013, New Zealand
08

References and documents

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06452771
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Jun 11, 2024
Start date
Jun 27, 2024
Primary completion
Dec 4, 2026 (estimated)
Completion
Dec 4, 2026 (estimated)
Last update
Feb 20, 2026

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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