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Completed

NCT Number: NCT01507077

ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity

The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).

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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-440). 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-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 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 ≤ 45 kg/m2
  • Stable body weight during the past 2 months

Exclusion criteria

  • Use of weight loss agents in the past month
  • History of eating disorder
  • History of type 1 or type 2 diabetes mellitus
  • Current smokers

Treatment and study plan

ZGN-440

Drug

Subjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.

Other names: Beloranib for subcutaneous injection

ZGN-440 sterile diluent

Drug

Subjects will receive placebo 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-440 for reduction of body weight in obese female volunteers.

    Time frame: Approximately 4 weeks

    Measures of the safety and tolerability of ZGN-440 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-440 to assess relationship to weight loss.

    Time frame: Approximately 4 weeks

  3. Elimination half-life of ZGN-440 to assess relationship to weight loss.

    Time frame: Approximately 4 weeks

Sponsors and collaborators

Lead sponsor

Zafgen, Inc.

Industry

Registry information

Official study title

ZGN-440 (Beloranib for Subcutaneous Injection), A Novel Methionine Aminopeptidase 2 Inhibitor for Treatment of Obesity: A Randomized Double-Blind Placebo Controlled Dose Escalation Phase 1b Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Initial Weight Loss

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 10, 2012
Registry last updated
Jul 18, 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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