NCT01028261

Brief Summary

The purpose of this study is to assess whether multiple doses of ZGN-433 is safe and well tolerated in obese female subjects. The study will also provide information on how much ZGN-433 gets into the blood, how long does it stay in the body, and how it affects other biological markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

December 7, 2009

Last Update Submit

January 9, 2012

Conditions

Obesity

Keywords

ObeseObesityOverweight

Outcome Measures

Primary Outcomes (1)

  • Measures of the safety and tolerability of ZGN-433 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, heart rhythm, and laboratory tests.

    Approximately 2 months

Secondary Outcomes (1)

  • Weight

    Approximately 2 months

Study Arms (2)

ZGN-433

EXPERIMENTAL
Drug: ZGN-433

Normal Saline

PLACEBO COMPARATOR
Drug: ZGN-433

Interventions

ZGN-433DRUG

Subjects will receive placebo or ZGN-433 twice weekly over 6 weeks treatment period for a total of 12 doses. A range of doses will be evaluated.

Also known as: Beloranib hemioxalate
Normal SalineZGN-433

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obese, otherwise healthy females
  • Post menopausal or infertile
  • Weight ≥ 50 kg
  • BMI ≥ 32 and ≤ 45 kg/m2

You may not qualify if:

  • Use of weight loss agents in the past month
  • History of eating disorder
  • History of diabetes or other endocrine disorder
  • History of gastric bypass
  • Current smokers
  • Unstable body weight during the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Q-Pharm Clinics, Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4006, Australia

Location

Nucleus Network

Heidelberg, Victoria, 3084, Australia

Location

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James E Vath, PhD

    Zafgen, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
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

December 7, 2009

First Posted

December 9, 2009

Study Start

December 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

AU(2)