NCT01818921

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

March 21, 2013

Last Update Submit

July 14, 2016

Conditions

ObesityOver-weightPrader-Willi Syndrome

Keywords

BeloranibZGN-440ZGN-440 for injectable suspensionZGN-433

Outcome Measures

Primary Outcomes (1)

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

    4 weeks

Secondary Outcomes (2)

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

    4 weeks

  • 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

Study Arms (3)

ZGN-440 sterile diluent

PLACEBO COMPARATOR

Subjects will receive placebo twice weekly subcutaneous injections for up to 6 weeks.

Drug: ZGN-440 sterile diluent

1.2 mg ZGN-440 for injectable suspension

EXPERIMENTAL

Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.

Drug: 1.2 mg ZGN-440 for injectable suspension

1.8 mg ZGN-440 for injectable suspension

EXPERIMENTAL

Subjects will receive ZGN-440 for injectable suspension (beloranib) twice weekly subcutaneous injections for up to 8 weeks.

Drug: 1.8 mg ZGN-440 for injectable suspension

Interventions

ZGN-440 sterile diluentDRUG

ZGN-440 sterile diluent/placebo

Also known as: Placebo
ZGN-440 sterile diluent
1.2 mg ZGN-440 for injectable suspensionDRUG

1.2 mg beloranib

Also known as: ZGN-440 for injectable suspension, ZGN-440, ZGN-433, Beloranib
1.2 mg ZGN-440 for injectable suspension
1.8 mg ZGN-440 for injectable suspensionDRUG

1.8 mg beloranib

Also known as: ZGN-440 for injectable suspension, ZGN-440, ZGN-433, Beloranib
1.8 mg ZGN-440 for injectable suspension

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610-0296, United States

Location

MeSH Terms

Conditions

ObesityPrader-Willi Syndrome

Interventions

CKD732

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornImprinting Disorders

Study Officials

  • Jennifer Miller, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
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

March 21, 2013

First Posted

March 27, 2013

Study Start

June 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

US(1)