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COMPLETED Phase 3

Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

NCT03156621 · View on ClinicalTrials.gov ↗

Study Summary

The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment. The secondary objectives of the study are: * To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein \[Apo\] A-1 and B, non-high-density lipoprotein cholesterol \[non-HDL-C\], total-cholesterol \[TC\], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C, triglycerides \[TG\]) in participants with HoFH * To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH * To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH * To assess the potential development of anti-drug (alirocumab) antibodies

Interventions

  • DRUG Placebo
  • DRUG Alirocumab

Study Locations (20)

Other

  • Regeneron Research Site — Prague
  • Regeneron Research Site — Marseille
  • Regeneron Research Site — Paris
  • Regeneron Research Site — Berlin
  • Regeneron Research Site — Athens
  • Regeneron Research Site — Ioannina
  • Regeneron Research Site — Naples
  • Regeneron Research Site — Roma

Quebec

  • Regeneron Research Site — Chicoutimi
  • Regeneron Research Site — Québec

Florida

  • Regeneron Research Site — Boca Raton

New York

  • Regeneron Research Site — New York

Ohio

  • Regeneron Research Site — Cincinnati

Texas

  • Regeneron Study Site — Dallas

Tyrol

  • Regeneron Research Site — Innsbruck

Hyōgo

  • Regeneron Research Site — Nishinomiya

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2017-10-03
Est. Completion 2020-02-13
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

290 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03156621

The ClinicalTrials.gov registry entry for NCT03156621 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Homozygous Familial Hypercholesterolemia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03156621 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Quebec, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03156621 about?

NCT03156621 is a clinical study titled "Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)". The primary objective of the study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to placebo after 12 weeks of treatment. The secondary objectives of the study are: * To evaluate the effect of aliro...

What is the current status of trial NCT03156621?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2017-10-03. Estimated completion is 2020-02-13.

What conditions does trial NCT03156621 study?

This clinical trial studies the following conditions: Homozygous Familial Hypercholesterolemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03156621?

The interventions under investigation include: Placebo (DRUG), Alirocumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03156621?

This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03156621 being conducted?

This trial has 20 study locations across Florida, New York, Ohio, Texas, Tyrol. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial