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Completed

NCT Number: NCT01818921

An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi Syndrome

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics for certain doses of beloranib in obese subjects with Prader-Willi Syndrome.

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Key information

Conditions

Obesity Abnormalities, Multiple Body Weight Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Imprinting Disorders Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Over-weight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prader-Willi Syndrome Signs and Symptoms

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida

Gainesville, Florida, 32610-0296, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of Prader-Willi Syndrome due to chromosome 15 micro-deletion, maternal uniparental disomy, or imprinting defect
  • BMI ≥25 kg/m2
  • Type 2 diabetes mellitus is allowed
  • Subject must agree to stay at the group home or under supervision of the group home or site staff (i.e. no home visits) for the duration of the study
  • Stable body weight during the past 3 months, except for during home visits

Exclusion criteria

  • Use of weight loss agents in the past 3 months
  • Type 1 diabetes mellitus
  • Current or anticipated chronic use of narcotics or opiates

Treatment and study plan

ZGN-440 sterile diluent

Drug

ZGN-440 sterile diluent/placebo

Other names: Placebo

1.2 mg ZGN-440 for injectable suspension

Drug

1.2 mg beloranib

Other names: ZGN-440 for injectable suspension, ZGN-440, ZGN-433, Beloranib

1.8 mg ZGN-440 for injectable suspension

Drug

1.8 mg beloranib

Other names: ZGN-440 for injectable suspension, ZGN-440, ZGN-433, Beloranib

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

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

    Time frame: 4 weeks

  2. Change in hyperphagia behavior, drive, and severity score (total score) from baseline to the end of the randomized dosing period using the PWS Hyperphagia Questionnaire

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Zafgen, Inc.

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label Extension

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 27, 2013
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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