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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02063295 | An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury | PHASE2 | COMPLETED | 14 | — | — | Apr 1, 2014 | Nov 1, 2014 | Jul 18, 2016 | 4 | United States, Australia |
| NCT01818921 | An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome | PHASE2 | COMPLETED | 17 | — | — | Jun 1, 2013 | Nov 1, 2013 | Jul 18, 2016 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| ZGN-440 sterile diluent | PLACEBO_COMPARATOR | Subjects will receive placebo twice weekly subcutaneous injections for 4 weeks. |
| ZGN-440 for injectable suspension | EXPERIMENTAL | Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. |
| 1.2 mg ZGN-440 for injectable suspension | EXPERIMENTAL | Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. |
| 1.8 mg ZGN-440 for injectable suspension | EXPERIMENTAL | Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks. |
| Name | Type | Description |
|---|---|---|
| ZGN-440 sterile diluent | DRUG | ZGN-440 sterile diluent/placebo |
| ZGN-440 for injectable suspension | DRUG | - |
| 1.2 mg ZGN-440 for injectable suspension | DRUG | 1.2 mg beloranib |
| 1.8 mg ZGN-440 for injectable suspension | DRUG | 1.8 mg beloranib |
Inclusion Criteria: * Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2 * Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary * Stable body weight fo...