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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01507077 | ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity | PHASE1 | COMPLETED | 25 | — | — | Dec 1, 2011 | Mar 1, 2012 | Jul 18, 2012 | 1 | Australia |
Measures of the safety and tolerability of ZGN-440 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
| Arm | Type | Description |
|---|---|---|
| ZGN-440 sterile diluent | PLACEBO_COMPARATOR | - |
| ZGN-440 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ZGN-440 | DRUG | Subjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated. |
| ZGN-440 sterile diluent | DRUG | Subjects will receive placebo 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 ≤ 45 kg/m2 * Stable body weight during the past 2 months Exclusion Criteria: * Use ...