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Leptin in HAART-Induced Lipodystrophy and Metabolic Syndrome
NCT00140244Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2001
- Primary completion
- Jun 2011
- Countries
- 1
- Sponsor
- Beth Israel Deaconess Medical Center
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- metreleptin
- Conditions
- lipodystrophymetabolic syndrome
01
Overview
Phase 2, randomised trial in lipodystrophy and metabolic syndrome comparing r-MetHuLeptin with Placebo (2 arms). Primary endpoint: Serum Lipid Levels at 2 months. Started Dec 2001; status: completed.
02
Design
2 arms- Study design
- Randomized
r-MetHuLeptin
r-MetHuLeptin SubQ once daily
Placebo
Placebo SubQ once daily
03
Who it enrols
Adults with documented HIV infection, exposed to at least 6 months of HAART, who developed fat depletion, have low leptin levels, and fasting triglycerides > 300 mg/dl (but <= 1000 mg/dl). Excludes patients with active infectious diseases (except HIV), prior diabetes, substance abuse, significant organ dysfunction, cancer, or pregnancy.
04
Endpoints
Primary
Serum Lipid Levels
Secondary
Insulin Resistance
Glycemia
Low Density Lipoprotein Cholesterol Levels
Free Fatty Acid Levels
Blood Pressure
Fibrinogen
Insulin Levels
Lean Body Mass
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