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

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818921
• Other study ID #: ZAF-211
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2013
• Last updated: July 14, 2016
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: July 2016
• Source: Zafgen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Over-weight
• Overweight
• Prader-Willi Syndrome
• Syndrome

Intervention

Drug:
• ZGN-440 sterile diluent
ZGN-440 sterile diluent/placebo
• 1.2 mg ZGN-440 for injectable suspension
1.2 mg beloranib
• 1.8 mg ZGN-440 for injectable suspension
1.8 mg beloranib

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zafgen, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in body weight from baseline to the end of the randomized dosing period.		4 weeks	No
Secondary	Change in body weight (kg) from baseline to the end of the randomized dosing period		4 weeks	No
Secondary	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		4 weeks	No