Back to resultsPharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
Primary Purpose
Obesity
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
ZGN-433
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obese, Obesity, Overweight
Eligibility Criteria
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 ≤ 50 kg/m2
- Stable body weight during the past month
Exclusion Criteria:
- Use of weight loss agents in the past month
- History of eating disorder
- History of gastric bypass surgery
- Current smokers
Sites / Locations
- Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Normal Saline
ZGN-433
Arm Description
Outcomes
Primary Outcome Measures
Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.
Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
Secondary Outcome Measures
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.
Peak plasma concentration of ZGN-433 to assess relationship to weight loss.
Elimination half-life of ZGN-433 to assess relationship to weight loss.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01372761
Brief Title
Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
Official Title
Phase 1b Trial of Beloranib, a Novel Methionine Aminopeptidase 2 (MetAP-2) Inhibitor for Treatment of Extreme Obesity: Randomized, Double-Blind, Placebo-Controlled, Escalating Doses in Female Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zafgen, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.
Detailed Description
This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-433). 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-433 gets into the blood, how long it stays in the body, and how it affects other biological markers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obese, Obesity, Overweight
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Title
ZGN-433
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZGN-433
Other Intervention Name(s)
Beloranib
Intervention Description
Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Primary Outcome Measure Information:
Title
Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.
Description
Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.
Time Frame
Approximately 4 weeks
Secondary Outcome Measure Information:
Title
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.
Time Frame
Approximately 4 weeks
Title
Peak plasma concentration of ZGN-433 to assess relationship to weight loss.
Time Frame
Approximately 4 weeks
Title
Elimination half-life of ZGN-433 to assess relationship to weight loss.
Time Frame
Approximately 4 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 ≤ 50 kg/m2
Stable body weight during the past month
Exclusion Criteria:
Use of weight loss agents in the past month
History of eating disorder
History of gastric bypass surgery
Current smokers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J K Marjason, MD
Organizational Affiliation
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
We'll reach out to this number within 24 hrs