CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Form… (NCT02654977) | Clinical Trial Compass
CompletedPhase 2
CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
United States11 participantsStarted 2015-09-29
Plain-language summary
The study investigators' aim is to determine the long term safety and efficacy of Metreleptin (Myalept,) in promoting amelioration of metabolic abnormalities in patients with all forms of partial lipodystrophy. Patients will be offered this protocol under the following condition: Subjects have completed University of Michigan research protocol MB002-014 and have shown improved clinical benefit as judged by clinical criteria set forth in this protocol.
Who can participate
Age range5 Years
SexALL
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Inclusion Criteria:
* Previously completed study protocol:
o CLINICAL PROTOCOL to investigate the efficacy of recombinant human leptin (METRELEPTIN) in nonalcoholic steatohepatitis (NASH) or nonalcoholic fatty liver disease (NAFLD) associated with lipodystrophy, MB002-014 (IRMBED: HUM00058708)
* Demonstrates clinical benefit as defined by meeting at least one of the following criteria upon completion of the above stated protocols:
* Reduction of HbA1c ≥ 1.0% or,
* Reduction of triglycerides ≥ 30% of baseline or,
* Decrease in insulin requirements ≥ 40% or,
* Reduction in total NASH score by ≥ 2 points,
* Significant worsening of metabolic parameters after discontinuation of Metreleptin if discontinuation has been undertaken.
* A health condition that appears to have significantly improved by metreleptin for which two independent health care providers make a request to prevent drug discontinuation. In addition, the PI has to document absence of contraindications for drug continuation (such as bone marrow suppression).
* Is male or female ≥ 5 years old at baseline.
* Is male, female not of childbearing potential, or meets all the following criteria if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):
* Not breastfeeding
* Negative pregnancy test result (human chorionic gonadotropin, beta subunit) at baseline (not applicable to hysterectomized females).
* Must practice and be willing to cont…
What they're measuring
1
Percent Change in Fasting Triglyceride Levels
Timeframe: 5 years on metreleptin or last observation carried forward