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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01666691 | An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects | PHASE2 | COMPLETED | 160 | — | — | Aug 1, 2012 | May 1, 2013 | Jul 14, 2016 | 3 | Australia |
Safety and tolerability of beloranib will be assessed by comparing frequency and severity of adverse events as well as changes in physical examinations, ECGs, vital signs and laboratory evaluations. Other safety oriented questionnaires and parameters (e.g. sleep quality, hemodynamic parameters) will be measured and evaluated.
Change from baseline in body weight and body composition (bioimpedance assessments), and scores of hunger/appetite over the dosing period will be evaluated to document beloranib's effect on obesity. Biomarkers of lipid metabolism will be measured to assess possible mechanisms of loss of body fat, as well as endocrinologic or anti-inflammatory markers.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | ZGN-440 sterile diluent |
| 0.3 mg Beloranib | EXPERIMENTAL | 0.3 mg ZGN-440 for injectable suspension |
| 0.6 mg Beloranib | EXPERIMENTAL | 0.6 mg ZGN-440 for injectable suspension |
| 1.2 mg Beloranib | EXPERIMENTAL | 1.2 mg ZGN-440 for injectable suspension |
| 2.4 mg Beloranib | EXPERIMENTAL | 2.4 mg ZGN-440 for injectable suspension |
| 3.2 mg Beloranib | EXPERIMENTAL | 3.2 mg ZGN-440 for injectable suspension |
| Name | Type | Description |
|---|---|---|
| Beloranib | DRUG | Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated. |
| Placebo | DRUG | Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. |
Inclusion Criteria: * Obese volunteers weighing ≥ 50 kg * BMI ≥ 30 and ≤ 50 kg/m2 * Stable body weight during the past 2 months * Type 2 diabetes mellitus is allowed Exclusion Criteria: * Use of weight loss agents in the past month * Current, clinically significant eating disorder * Type 1 diabet...