CompletedPhase 2/3

Trial of Leptin Replacement Therapy in Patients With Lipodystrophy

United States25 participantsStarted 2006-04

Plain-language summary

Lipodystrophies represent a therapeutic challenge with regards to insulin resistance, hypertriglyceridemia and fatty liver which often is coupled with significant adipose tissue loss. The purpose of the study is to examine the safety and efficacy of Leptin on subjects with lipodystrophy.

Who can participate

Age range6 Years – 70 Years

SexALL

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Inclusion criteria

✓. Type 2 Diabetes Mellitus
✓. Fasting serum insulin \>20 uU/mL
✓. Fasting serum triglycerides \> 300 mg/dL
✓. Previous participation in leptin trial (Amgen 991265, GCRC 660) - for Part B of the Study.

What they're measuring

Fasting Serum Triglycerides

Timeframe: 4 months

HbA1c

Timeframe: 4 months

Trial details

NCT IDNCT00896298

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-11

Results submitted2019-01-15

View on ClinicalTrials.gov More Hypoleptinemia trials