Obesity
Conditions
Keywords
Obese, Obesity, Overweight, Weight loss, Weight reduction, Beloranib
Brief summary
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.
Detailed description
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.
Interventions
DRUGBeloranib
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.
DRUGPlacebo
Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses.
Sponsors
Zafgen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks | Up to 26 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. |
| Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440 | Up to 13 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics over a dose range of beloranib | Up to 12 weeks | 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. |
| 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 | Up to 12 weeks | Bioavailability will be estimated from the SC PK parameters compared to the profile from comparable doses in earlier IV administration studies. |
Countries
Australia
Outcome results
None listed