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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01372761 | Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers | PHASE1 | COMPLETED | 25 | — | — | Jun 1, 2011 | Nov 1, 2011 | Dec 30, 2011 | 1 | Australia |
| NCT01028261 | Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers | PHASE1 | COMPLETED | 31 | — | — | Dec 1, 2009 | Oct 1, 2010 | Jan 11, 2012 | 2 | Australia |
Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
| Arm | Type | Description |
|---|---|---|
| Normal Saline | PLACEBO_COMPARATOR | - |
| ZGN-433 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ZGN-433 | DRUG | Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated. |
| Normal Saline | DRUG | Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated. |
Inclusion Criteria: * Obese but otherwise healthy females * Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months) * BMI ≥ 30 and ≤ 50 kg/m2 * Stable body weight during the past month Exclusion Criteria: * Use of ...