LOWER: Lomitapide Observational Worldwide Evaluation Registry

  • End date
    Sep 1, 2028
  • participants needed
  • sponsor
    Amryt Pharma
Updated on 27 January 2021


This global product exposure registry is a multicentre, long-term, prospective, observational cohort study (exposure registry), designed to evaluate the long term safety and effectiveness of lomitapide.


To evaluate the occurrence of adverse events of special interest, long term effectiveness of lomitapide, and to evaluate whether prescribers of lomitapide are following screening and monitoring recommendations as specified in product labeling.

Condition Homozygous Familial Hypercholesterolemia
Treatment Lomitapide
Clinical Study IdentifierNCT02135705
SponsorAmryt Pharma
Last Modified on27 January 2021


Yes No Not Sure

Inclusion Criteria

Adult patients (age 18 years) who meet one of the following two criteria
Initiating treatment with lomitapide at the time of registry enrolment, or
initiated treatment with lomitapide within 36 months prior to enrolment into
the registry and after lomitapide commercial availability in the country
Patients who have the ability to understand the requirements of the study and provide written informed consent to comply with the study data collection procedures

Exclusion Criteria

Patients who are receiving lomitapide in clinical trials or through compassionate use where patients are followed under a separate protocol
Patients receiving an investigational agent, defined as any drug or biologic agent other than lomitapide that has not received MA in the country of participation
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Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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