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Completed

NCT Number: NCT02063295

An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Hypothalamic Injury

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of beloranib in obese subjects with hypothalamic injury.

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Key information

Conditions

Obesity Body Weight Craniopharyngioma Hypothalamic Injury Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Nutrition Disorders Nutritional and Metabolic Diseases Over-weight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Boden Institute, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Obesity as a consequence of acquired anatomical hypothalamic damage as evidenced by BMI ≥30 and ≤60 kg/m2
  • Greater than 6 months post-treatment, including chemotherapy, surgery or radiation with resulting injury to the hypothalamus and/or the pituitary
  • Stable body weight for at least 3 months
  • Type 2 diabetes mellitus is allowed

Exclusion criteria

  • Males taking gonadotropin replacement therapy (LH/FSH)
  • Subjects who are planning any fertility treatment within 6 months of study participation
  • Use of weight loss agents, including herbal medications, in the past 3 months
  • Current or anticipated chronic use of narcotics or opiates
  • History of severe psychiatric disorders
  • Type 1 diabetes mellitus
  • Metabolic disorders or genetic disorders linked to obesity
  • History of any bariatric surgery
  • Participation in any clinical study with an investigational drug or device within the 3 months prior to enrollment in this study
  • Blood loss or donation >500 mL within the past 3 months
  • Females who are pregnant, nursing, intend to become pregnant during the study or any males who plan to father/conceive a child within 6 months after completion of study participation

Treatment and study plan

ZGN-440 sterile diluent

Drug

ZGN-440 sterile diluent/placebo

Other names: Placebo

ZGN-440 for injectable suspension

Drug

Other names: ZGN-440, Beloranib

Primary outcomes

  1. Change in body weight from baseline to the end of the randomized dosing period.

    Time frame: 4 weeks

Secondary outcomes

  1. Change in lipid profile (cholesterol, LDL, HDL, triglycerides) from baseline to the end of the randomized dosing period

    Time frame: 4 weeks

  2. Change in hs-CRP from baseline to the end of the randomized dosing period.

    Time frame: 4 weeks

  3. Change in hunger from baseline to the end of the randomized dosing period.

    Time frame: 4 weeks

  4. Change in quality of life from baseline to the end of the randomized dosing period.

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Zafgen, Inc.

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo Controlled, Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Obese Subjects With Hypothalamic Injury to Evaluate Weight Reduction and Safety Over 4 Weeks Followed by an Optional 4-Week Open-Label Extension

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Jul 18, 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.

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