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Safety, Tolerability and Pharmacokinetics of Multiple Doses of ZGN-433 in Obese Female Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zafgen, Inc.
ClinicalTrials.gov Identifier:
NCT01028261
First received: December 7, 2009
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
 Drug: ZGN-433
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZGN-433 in Obese Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Zafgen, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: December 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZGN-433 Drug: ZGN-433
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.
Other Name: Beloranib hemioxalate
Placebo Comparator: Normal Saline Drug: ZGN-433
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.
Other Name: Beloranib hemioxalate

Detailed Description:

This protocol is designed to test the safety and preliminary efficacy of a drug called ZGN-433. It is to be tested for its ability to reduce weight in severely obese female subjects who are post menopausal or infertile.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028261

Locations
Australia, Queensland
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4006
Australia, Victoria
Nucleus Network
Heidelberg, Victoria, Australia, 3084
Sponsors and Collaborators
Zafgen, Inc.
Investigators
Study Director: James E Vath, PhD Zafgen, Inc.
  More Information

No publications provided

Responsible Party: Zafgen, Inc.
ClinicalTrials.gov Identifier: NCT01028261     History of Changes
Other Study ID Numbers: ZAF-001
Study First Received: December 7, 2009
Last Updated: January 9, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Keywords provided by Zafgen, Inc.:
Obese
Obesity
Overweight

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013