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

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ClinicalTrials.gov Identifier: NCT01372761
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : December 30, 2011
Sponsor:
Information provided by (Responsible Party):
Zafgen, Inc.

Study Description
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Brief Summary:
The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.

Condition or disease Intervention/treatment Phase
Obesity Drug: ZGN-433 Drug: Normal Saline Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2011
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Normal Saline 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.
Experimental: ZGN-433 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Peak plasma concentration of ZGN-433 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ]
  3. Elimination half-life of ZGN-433 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372761


Locations
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Australia, Queensland
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Sponsors and Collaborators
Zafgen, Inc.
Investigators
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Principal Investigator: J K Marjason, MD Q-Pharm Clinics, Royal Brisbane and Women's Hospital
More Information
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Responsible Party: Zafgen, Inc.
ClinicalTrials.gov Identifier: NCT01372761    
Other Study ID Numbers: ZAF-003AUS
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011
Keywords provided by Zafgen, Inc.:
Obese
Obesity
Overweight
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
CKD732
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents