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Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01372761
First Posted: June 14, 2011
Last Update Posted: December 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zafgen, Inc.
June 8, 2011
June 14, 2011
December 30, 2011
June 2011
November 2011   (Final data collection date for primary outcome measure)
Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers. [ Time Frame: Approximately 4 weeks ]
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.
Same as current
Complete list of historical versions of study NCT01372761 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Peak plasma concentration of ZGN-433 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ]
  • Elimination half-life of ZGN-433 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
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
The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Drug: ZGN-433
    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.
    Other Name: Beloranib
  • Drug: Normal Saline
    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.
  • Placebo Comparator: Normal Saline
    Intervention: Drug: Normal Saline
  • Experimental: ZGN-433
    Intervention: Drug: ZGN-433
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01372761
ZAF-003AUS
No
Not Provided
Not Provided
Zafgen, Inc.
Zafgen, Inc.
Not Provided
Principal Investigator: J K Marjason, MD Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Zafgen, Inc.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP