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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014