Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00140244 | Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome | PHASE2 | COMPLETED | 7 | — | — | Dec 1, 2001 | Jun 1, 2011 | May 11, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| r-MetHuLeptin | ACTIVE_COMPARATOR | r-MetHuLeptin SubQ once daily |
| Placebo | PLACEBO_COMPARATOR | SubQ once daily |
| Name | Type | Description |
|---|---|---|
| r-metHuLeptin | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * At least 18 years old * Documented HIV infection * Exposed to at least 6 months of cumulative highly active antiretroviral medications for HIV * Developed fat depletion after starting HIV medications * Low leptin level in the blood * Fasting triglyceride level \> 300 mg/dl Ex...