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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Zafgen, Inc.

ClinicalTrials.gov Identifier:

NCT01372761

First received: June 8, 2011

Last updated: December 28, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

June 8, 2011

Last Updated Date

December 28, 2011

Start Date ^ICMJE

June 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]

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 ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01372761 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Peak plasma concentration of ZGN-433 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
Elimination half-life of ZGN-433 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Obesity

Intervention ^ICMJE

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 Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT01372761

Other Study ID Numbers ^ICMJE

ZAF-003AUS

Has Data Monitoring Committee

Responsible Party

Zafgen, Inc.

Study Sponsor ^ICMJE

Zafgen, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

J K Marjason, MD

Q-Pharm Clinics, Royal Brisbane and Women's Hospital

Information Provided By

Zafgen, Inc.

Verification Date

December 2011

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

To Top