MEASuRE: Metreleptin Effectiveness And Safety Registry for Lipodystrophy
This study, called MEASuRE, is looking at the long-term safety of metreleptin when used by patients with Generalised Lipodystrophy or Partial Lipodystrophy in their daily lives. It's an observational study, meaning researchers will collect information from people already taking metreleptin, rather than giving them a new treatment. The main goal is to track how often certain safety events, like pancreatitis or infections, occur over at least 10 years. You might be able to join if you are already being treated with metreleptin commercially, or if you are coming off a metreleptin clinical study and continuing the treatment. The study is currently unclear on its recruitment status, but plans to enroll about 100 participants.
- Study design
- This is an observational study, not a clinical trial where a treatment is tested. It will follow about 100 participants who are already taking metreleptin.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety events will be collected from the first dose to the last visit, for a minimum of 10 years. For those already taking metreleptin, serious adverse events will be collected from 6 months before joining the study to the last visit, for a minimum of 10 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
MEASuRE: Metreleptin Effectiveness And Safety Registry
At a glance
Conditions
Where it's being run
28 sites across 25 statesStudy leadership
- Lori Hartnett · STUDY_DIRECTOR · Amryt Pharmaceuticals DAC
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- The severity and incidence of the following safety events in patients prescribed Metreleptin in routine clinical practiceAdverse events will be collected from first dose to last visit - min. 10 years. For Prevalent Users: Serious adverse events will be collected from 6 months prior to enrolment to last visit - min. 10 years.
Estimation of the incidence rates of the following events of special interest in patients treated with metreleptin as part of current clinical practice: acute pancreatitis associated with discontinuation of metreleptin including fatal or necrotizing pancreatitis, hepatic adverse events, severe hypoglycemia, serious hypersensitivity reactions, serious and severe infections resulting in hospitalization or death, loss of efficacy, new diagnoses of autoimmune disorders, autoimmune disease exacerbation, all cancers, exposed pregnancies and pregnancy outcomes, all-cause deaths, medication errors.