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The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.
This protocol is designed to test the safety and efficacy of a drug called beloranib (ZGN-440 for injectable suspension). It is to be tested for its ability to reduce weight in obese subjects. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks | 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. | Up to 26 weeks |
| Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440 | 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. | Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics over a dose range of beloranib | The plasma PK of beloranib and selected metabolites may be assessed following dose administration to compare systemic exposure and PK parameters over the range of doses. PK parameters include Cmax, Tmax, AUC24hour, AUC∞, volume of distribution, total clearance, terminal elimination constant, and half-life. Mean residence time may also be reported. | Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J K Marjason, MD | Q-Pharm Clinics, Royal Brisbane and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Clinics, Royal Brisbane and Women's Hospital | Brisbane | Queensland | Australia | |||
| CMAX |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C487952 | CKD732 |
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|
| Placebo | Drug | Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. |
|
|
| Compare the plasma pharmacokinetic profile of beloranib administered subcutaneously with the profiles obtained previously using an alternative formulation administered subcutaneously and with ZGN-433 (beloranib hemioxalate) administered intravenously | Up to 12 weeks |
| Apparent bioavailability over a dose range of beloranib | Bioavailability will be estimated from the SC PK parameters compared to the profile from comparable doses in earlier IV administration studies. | Up to 12 weeks |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Linear Clinical Research Ltd | Perth | Western Australia | 6009 | Australia |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |