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.