Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome

NCT02179151 | Terminated Phase 3 DMC

• 1 other identifier: ZAF-311
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to evaluate efficacy and safety of ZGN-440 (beloranib) in obese adolescent and adult subjects with Prader-Willi Syndrome.

Conditions

Prader-Willi Syndrome; Obesity

Keywords

Prader-Willi Syndrome; Obesity; Hyperphagia

Outcome Measures

Primary Outcomes (2)

• Change in total body weight

  Baseline to Week 29

• Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire

  Baseline to Week 29

Secondary Outcomes (5)

• Change in LDL cholesterol

  Baseline to Week 29

• Change in HDL cholesterol

  Baseline to Week 29

• Change in total body mass as measured by DXA

  Baseline to Week 29

• Change in total body fat mass as measured by DXA

  Baseline to Week 29

• Change in triglyceride

  Baseline to Week 29

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Intervention: ZGN-440 Placebo for Injectable Suspension

Drug: ZGN-440 Placebo for Injectable Suspension

ZGN-440 Injectable Suspension (1.8 mg)

EXPERIMENTAL

Intervention: ZGN-440 for Injectable Suspension

Drug: ZGN-440 for Injectable Suspension

ZGN-440 Injectable Suspension (2.4 mg)

EXPERIMENTAL

Intervention: ZGN-440 for Injectable Suspension

Drug: ZGN-440 for Injectable Suspension

Interventions

ZGN-440 for Injectable Suspension DRUG

Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.

Also known as: ZGN-440, Beloranib

ZGN-440 Injectable Suspension (1.8 mg); ZGN-440 Injectable Suspension (2.4 mg)

ZGN-440 Placebo for Injectable Suspension DRUG

Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed genetic diagnosis of Prader-Willi Syndrome
• Age 12-65
• Obesity
• Age 12-17: BMI ≥ 95th percentile for age and gender
• Age 18-65: BMI ≥27 to ≤60 kg/m2

You may not qualify if:

• Subjects living in a group home ≥ 50% of the time
• Recent use (within 3 months) of weight loss agents including herbal medication
• Poorly controlled severe psychiatric disorders

Sponsors & Collaborators

• Zafgen, Inc.: lead

Study Sites (15)

University of California, Davis

Sacramento, California, 95817, United States

Location

UCSD: Rady Children's Hospital

San Diego, California, 92123, United States

Location

Children's Hospital of Colorado

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

National Institute of Child Health

Bethesda, Maryland, 20892, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Children's Hospital and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Winthrop University

Mineola, New York, 11501, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Seattle Children's Research Institute

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• McCandless SE, Yanovski JA, Miller J, Fu C, Bird LM, Salehi P, Chan CL, Stafford D, Abuzzahab MJ, Viskochil D, Barlow SE, Angulo M, Myers SE, Whitman BY, Styne D, Roof E, Dykens EM, Scheimann AO, Malloy J, Zhuang D, Taylor K, Hughes TE, Kim DD, Butler MG. Effects of MetAP2 inhibition on hyperphagia and body weight in Prader-Willi syndrome: A randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2017 Dec;19(12):1751-1761. doi: 10.1111/dom.13021. Epub 2017 Jul 13.

  PMID: 28556449 DERIVED

MeSH Terms

Conditions

Prader-Willi Syndrome; Obesity; Hyperphagia

Interventions

CKD732

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Dennis Kim, MD

  Zafgen, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: July 1, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: October 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)