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An Efficacy, Safety and Pharmacokinetics Study of Beloranib (ZGN-440 for Injectable Suspension) in Obese Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01666691
First Posted: August 16, 2012
Last Update Posted: July 14, 2016
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.
  Purpose
The purpose of this study is to evaluate weight reduction, safety and pharmacokinetics for certain doses of beloranib (ZGN-440 for injectable suspension) administered as twice-weekly subcutaneous injections for 12 weeks.

Condition Intervention Phase
Obesity Drug: Beloranib Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo Controlled, Dose Ranging Phase 2 Trial of Beloranib (ZGN-440 for Injectable Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects to Evaluate Weight Reduction, Safety, and Pharmacokinetics Over 12 Weeks

Resource links provided by NLM:


Further study details as provided by Zafgen, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 weeks [ Time Frame: Up to 26 weeks ]
    Safety and tolerability of beloranib will be assessed by comparing frequency and severity of adverse events as well as changes in physical examinations, ECGs, vital signs and laboratory evaluations. Other safety oriented questionnaires and parameters (e.g. sleep quality, hemodynamic parameters) will be measured and evaluated.

  • Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440 [ Time Frame: Up to 13 weeks ]
    Change from baseline in body weight and body composition (bioimpedance assessments), and scores of hunger/appetite over the dosing period will be evaluated to document beloranib's effect on obesity. Biomarkers of lipid metabolism will be measured to assess possible mechanisms of loss of body fat, as well as endocrinologic or anti-inflammatory markers.


Secondary Outcome Measures:
  • Pharmacodynamics over a dose range of beloranib [ Time Frame: Up to 12 weeks ]
    The plasma PK of beloranib and selected metabolites may be assessed following dose administration to compare systemic exposure and PK parameters over the range of doses. PK parameters include Cmax, Tmax, AUC24hour, AUC∞, volume of distribution, total clearance, terminal elimination constant, and half-life. Mean residence time may also be reported.

  • Compare the plasma pharmacokinetic profile of beloranib administered subcutaneously with the profiles obtained previously using an alternative formulation administered subcutaneously and with ZGN-433 (beloranib hemioxalate) administered intravenously [ Time Frame: Up to 12 weeks ]
  • Apparent bioavailability over a dose range of beloranib [ Time Frame: Up to 12 weeks ]
    Bioavailability will be estimated from the SC PK parameters compared to the profile from comparable doses in earlier IV administration studies.


Enrollment: 160
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
ZGN-440 sterile diluent
Drug: Placebo
Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses.
Other Name: ZGN-440 sterile diluent
Experimental: 0.3 mg Beloranib
0.3 mg ZGN-440 for injectable suspension
Drug: Beloranib
Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.
Other Names:
  • ZGN-440 for injectable suspension
  • ZGN-440
  • ZGN-433
Experimental: 0.6 mg Beloranib
0.6 mg ZGN-440 for injectable suspension
Drug: Beloranib
Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.
Other Names:
  • ZGN-440 for injectable suspension
  • ZGN-440
  • ZGN-433
Experimental: 1.2 mg Beloranib
1.2 mg ZGN-440 for injectable suspension
Drug: Beloranib
Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.
Other Names:
  • ZGN-440 for injectable suspension
  • ZGN-440
  • ZGN-433
Experimental: 2.4 mg Beloranib
2.4 mg ZGN-440 for injectable suspension
Drug: Beloranib
Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.
Other Names:
  • ZGN-440 for injectable suspension
  • ZGN-440
  • ZGN-433
Experimental: 3.2 mg Beloranib
3.2 mg ZGN-440 for injectable suspension
Drug: Beloranib
Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.
Other Names:
  • ZGN-440 for injectable suspension
  • ZGN-440
  • ZGN-433

Detailed Description:
This protocol is designed to test the safety and efficacy of a drug called beloranib (ZGN-440 for injectable suspension). It is to be tested for its ability to reduce weight in obese subjects. The study will provide information on how much ZGN-440 gets into the blood, how long it stays in the body, and how it affects other biological markers.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese volunteers weighing ≥ 50 kg
  • BMI ≥ 30 and ≤ 50 kg/m2
  • Stable body weight during the past 2 months
  • Type 2 diabetes mellitus is allowed

Exclusion Criteria:

  • Use of weight loss agents in the past month
  • Current, clinically significant eating disorder
  • Type 1 diabetes mellitus
  Contacts and Locations
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): NCT01666691


Locations
Australia, Queensland
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Australia, South Australia
CMAX
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Linear Clinical Research Ltd
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
Zafgen, Inc.
Investigators
Principal Investigator: J K Marjason, MD Q-Pharm Clinics, Royal Brisbane and Women's Hospital
  More Information

Responsible Party: Zafgen, Inc.
ClinicalTrials.gov Identifier: NCT01666691     History of Changes
Other Study ID Numbers: ZAF-201
First Submitted: August 8, 2012
First Posted: August 16, 2012
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Zafgen, Inc.:
Obese
Obesity
Overweight
Weight loss
Weight reduction
Beloranib