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

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

Tracking Information

• First Submitted Date: June 8, 2011
• First Posted Date: June 14, 2011
• Last Update Posted Date: December 30, 2011
• Study Start Date: June 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2011)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 10, 2011)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• 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.

Study Arms

• Placebo Comparator: Normal Saline
  Intervention: Drug: Normal Saline
• Experimental: ZGN-433
  Intervention: Drug: ZGN-433

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 28, 2011): 25
• Original Estimated Enrollment (submitted: June 10, 2011): 18
• Actual Study Completion Date: November 2011
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT01372761
• Other Study ID Numbers: ZAF-003AUS
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Zafgen, Inc.
• Original Responsible Party: James Vath, PhD - Head of Discovery and Development, Zafgen, Inc.
• Current Study Sponsor: Zafgen, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: J K Marjason, MD; Q-Pharm Clinics, Royal Brisbane and Women's Hospital

• PRS Account: Zafgen, Inc.
• Verification Date: December 2011