Clinical trial NCT02179151: Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome
Official title: Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Prader-Willi Syndrome
Obesity
Keywords: Prader-Willi Syndrome
Obesity
Hyperphagia
Lead sponsor: Zafgen, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-01
Enrollment: 108
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Phase 3, Randomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects with Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 Months

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in total body weight
timeFrame: Baseline to Week 29
measure: Change in hyperphagia-related behavior as measured by total score of a Hyperphagia Questionnaire
timeFrame: Baseline to Week 29
Secondary outcomes:
measure: Change in LDL cholesterol
timeFrame: Baseline to Week 29
measure: Change in HDL cholesterol
timeFrame: Baseline to Week 29
measure: Change in total body mass as measured by DXA
timeFrame: Baseline to Week 29
measure: Change in total body fat mass as measured by DXA
timeFrame: Baseline to Week 29
measure: Change in triglyceride
timeFrame: Baseline to Week 29
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Diego
country: United States
facility: UCSD: Rady Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Bethesda
country: United States
facility: National Institute of Child Health
state: Maryland
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: St. Paul
country: United States
facility: Children's Hospital and Clinics of Minnesota
state: Minnesota
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Mineola
country: United States
facility: Winthrop University
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Research Institute
state: Washington
Study officials:
affiliation: Zafgen, Inc.
name: Dennis Kim, MD
role: STUDY_DIRECTOR
References:
citation: 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.