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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666691
• Other study ID #: ZAF-201
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2012
• Last updated: July 13, 2016
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2016
• Source: Zafgen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• Placebo
Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses.

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia
Australia	Q-Pharm Clinics, Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Linear Clinical Research Ltd	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Zafgen, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of beloranib (ZGN-440 for injectable suspension) administered subcutaneously for 12 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.	Up to 26 weeks	Yes
Primary	Weight loss and responses in metabolic biomarkers over a dose range of ZGN-440	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.	Up to 13 weeks	No
Secondary	Pharmacodynamics over a dose range of beloranib	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, AUC8, volume of distribution, total clearance, terminal elimination constant, and half-life. Mean residence time may also be reported.	Up to 12 weeks	No
Secondary	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		Up to 12 weeks	No
Secondary	Apparent bioavailability over a dose range of beloranib	Bioavailability will be estimated from the SC PK parameters compared to the profile from comparable doses in earlier IV administration studies.	Up to 12 weeks	No