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Metreleptin for Lipodystrophy
Study Summary
This trial is testing the safety and effectiveness of metreleptin, a drug that has been shown to improve health in people with partial lipodystrophy. Eligible participants will receive free metreleptin and travel assistance to NIH for regular checkups.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 2 trial • 103 Patients • NCT00025883Trial Design
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Who is running the clinical trial?
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- You are currently abusing alcohol or drugs.I have seen improvements in my health from metreleptin treatment.I can get metreleptin through prescription, compassionate use, or a special program.You have a mental health condition that makes it hard for you to understand or follow the study rules.I have partial lipodystrophy.You are allergic to proteins derived from E. coli.I do not have any health conditions or take medications that would increase my risk.I have HIV or a condition called lipodystrophy related to HIV.You have been treated with metreleptin in certain previous research studies.I am at least 6 months old.
- Group 1: Leptin therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has this intervention been approved by the regulating body?
"Given the Phase 2 status of this treatment, there is limited clinical evidence supporting its safety but no data to back up efficacy. Thus, our team at Power assigned a rating of two out of three."
Is this trial actively seeking out new participants?
"Details found on clinicaltrials.gov reveal that, since the original posting of this study on October 14th 2014 and its most recent update on September 9th 2022, it is no longer recruiting patients. However, presently there are 246 other trials looking for enrollees."
What is the scope of participation in this research project?
"This trial is no longer recruiting patients. It was initially posted on October 14th 2014 and last updated September 9th 2022. However, there are currently 241 studies focusing on lipidemia which are still open to participants, as well as 5 trials offering this particular treatment with positions available."
Is there any precedent for this treatment, as demonstrated by prior research?
"At the present moment, 5 studies are underway for this treatment with 2 of them being in Phase 3. Columbus Ohio is hosting most of these trials while 14 other sites across America offer access to it as well."
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