|Product||Study type||Status||Study title||clinicaltrials.gov identifier|
|Lomitapide||Phase 3 study||Planned||Phase III, Single-arm, Open-label, International, Multi-centre Study to Evaluate the Efficacy and Safety of Lomitapide in Paediatric Patients with Homozygous Familial Hypercholesterolaemia (HoFH) on Stable Lipid-lowering Therapy|
|Lomitapide||Phase 3 study||Recruiting||Safety of Lomitapide in Paediatric Patients With Homozygous Familial Hypercholesterolaemia (HoFH)||NCT04681170|
|Metreleptin||Phase 3 study||Planned||A 12-Month Randomised, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Patients with Partial Lipodystrophy|
|Metreleptin||Phase 4 study||Recruiting||Immunogenicity of Metreleptin in Patients With Generalised Lipodystrophy||NCT04026178|
|Oleogel-S10||Phase 3 study||Active, not recruiting||Phase 3 Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (EASE)||NCT03068780|
|Lomitapide||Registry||Recruiting||LOWER: Lomitapide Observational Worldwide Evaluation Registry||NCT02135705|
|Metreleptin||Registry||Recruiting||MEASuRE: Metreleptin Effectiveness And Safety Registry||NCT02325674|
The Lomitapide Observational Worldwide Evaluation Registry (LOWER), a post-marketing requirement to study the long-term safety, effectiveness and patterns of use in patients treated with lomitapide globally.
The Registry is currently enrolling in US, Europe, UK, Canada and Argentina. The Registry will enrol at least 300 adult HoFH patients who will be followed for a minimum of 10 years, in the EU and UK patients will be enrolled and followed indefinitely. The inclusion criteria include patients who commenced therapy with lomitapide. The exclusion criteria include those receiving lomitapide in a clinical trial or receiving an investigational agent.
For more information on enrolling in the LOWER Registry, please contact medical information, [email protected]
The global MEASuRE registry has been established to further evaluate the long-term safety and effectiveness of metreleptin in patients with generalised or partial lipodystrophy treated with metreleptin. The registry was initially established following approval of metreleptin in the United States to treat patients with generalised lipodystrophy and has now been expanded following approval in the EU to include metreleptin treated patients with both generalised and partial lipodystrophy.
The Registry will enrol at least 100 patients who will be followed for a minimum of 10 years, in the EU and UK patients will be enrolled and followed indefinitely.
For more information on enrolling in the MEASuRE Registry, please contact medical information, [email protected]
The MACRO Registry is the first ever acromegaly disease state registry in the United States.
For more information on enrolling in the MACRO registry please contact Medical Information at [email protected].
AMYT/ALL/006 August 2021