Overview

LOWER: Lomitapide Observational Worldwide Evaluation Registry

Status:
Recruiting
Trial end date:
2028-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aegerion Pharmaceuticals, Inc.
Amryt Pharma
Criteria
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.