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Completed

NCT Number: NCT01372761

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

The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.

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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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ZGN-433

Drug

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 names: Beloranib

normal saline

Drug

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.

Primary outcomes

  1. Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.

    Time frame: Approximately 4 weeks

    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.

Secondary outcomes

  1. 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

  2. Peak plasma concentration of ZGN-433 to assess relationship to weight loss.

    Time frame: Approximately 4 weeks

  3. Elimination half-life of ZGN-433 to assess relationship to weight loss.

    Time frame: Approximately 4 weeks

Sponsors and collaborators

Lead sponsor

Zafgen, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 14, 2011
Registry last updated
Dec 30, 2011

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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