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Completed

NCT Number: NCT01028261

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

The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well tolerated in obese female subjects. The study will also provide information on how much ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

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About this study

This protocol is designed to test the safety and preliminary efficacy of a drug called ZGN-433. It is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Obese, otherwise healthy females
  • Post menopausal or infertile
  • Weight ≥ 50 kg
  • BMI ≥ 32 and ≤ 45 kg/m2

Exclusion criteria

  • Use of weight loss agents in the past month
  • History of eating disorder
  • History of diabetes or other endocrine disorder
  • History of gastric bypass
  • Current smokers
  • Unstable body weight during the past 3 months

Treatment and study plan

ZGN-433

Drug

Subjects will receive placebo or ZGN-433 twice weekly over 6 weeks treatment period for a total of 12 doses. A range of doses will be evaluated.

Other names: Beloranib hemioxalate

Primary outcomes

  1. 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.

    Time frame: Approximately 2 months

Secondary outcomes

  1. Weight

    Time frame: Approximately 2 months

Sponsors and collaborators

Lead sponsor

Zafgen, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZGN-433 in Obese Volunteers

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2009
Registry last updated
Jan 11, 2012

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.

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