Skip to main content
OpenTrials
Completed

NCT Number: NCT01666691

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beloranib

Drug

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

Placebo

Drug

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

Other names: ZGN-440 sterile diluent

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Zafgen, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2012
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.