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

NCT01818921 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-07-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ZGN-440 sterile diluent

ZGN-440 sterile diluent/placebo

DRUG

1.2 mg ZGN-440 for injectable suspension

1.2 mg beloranib

DRUG

1.8 mg ZGN-440 for injectable suspension

1.8 mg beloranib

Sponsors & Collaborators

  • Zafgen, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Miller, MD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818921 on ClinicalTrials.gov