Obesity
Conditions
Keywords
Obese, Obesity, Overweight
Brief summary
The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).
Detailed description
This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-440). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. 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
DRUGZGN-440
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.
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.
Sponsors
Zafgen, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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 of weight loss agents in the past month * History of eating disorder * History of type 1 or type 2 diabetes mellitus * Current smokers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate safe doses of ZGN-440 for reduction of body weight in obese female volunteers. | Approximately 4 weeks | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability. | Approximately 4 weeks |
| Peak plasma concentration of ZGN-440 to assess relationship to weight loss. | Approximately 4 weeks |
| Elimination half-life of ZGN-440 to assess relationship to weight loss. | Approximately 4 weeks |
Countries
Australia
Outcome results
None listed