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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zafgen, Inc.
ClinicalTrials.gov Identifier:
NCT01372761
First received: June 8, 2011
Last updated: December 28, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.


Condition Intervention Phase
Obesity
 Drug: ZGN-433
Drug: Normal Saline
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1b Trial of Beloranib, a Novel Methionine Aminopeptidase 2 (MetAP-2) Inhibitor for Treatment of Extreme Obesity: Randomized, Double-Blind, Placebo-Controlled, Escalating Doses in Female 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:
  • Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, ECGs, vital signs and/or laboratory evaluations as a measure of safety and tolerability. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
  • Peak plasma concentration of ZGN-433 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
  • Elimination half-life of ZGN-433 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal Saline Drug: Normal Saline
Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Experimental: ZGN-433 Drug: ZGN-433
Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Other Name: Beloranib

Detailed Description:

This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-433). It is to be tested for its ability to reduce weight in obese female subjects who are of non-childbearing potential. The study will provide information on how much ZGN-433 gets into the blood, how long it stays in the body, and how it affects other biological markers.

  Eligibility

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

Inclusion Criteria:

  • Obese but otherwise healthy females
  • Non-childbearing potential (surgically sterile, post-menopausal, or receiving implanted or injectable contraceptive for at least 3 months)
  • BMI ≥ 30 and ≤ 50 kg/m2
  • Stable body weight during the past month

Exclusion Criteria:

  • Use of weight loss agents in the past month
  • History of eating disorder
  • History of gastric bypass surgery
  • Current smokers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372761

Locations
Australia, Queensland
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Sponsors and Collaborators
Zafgen, Inc.
Investigators
Principal Investigator: J K Marjason, MD Q-Pharm Clinics, Royal Brisbane and Women's Hospital
  More Information

No publications provided

Responsible Party: Zafgen, Inc.
ClinicalTrials.gov Identifier: NCT01372761     History of Changes
Other Study ID Numbers: ZAF-003AUS
Study First Received: June 8, 2011
Last Updated: December 28, 2011
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 16, 2013