ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zafgen, Inc.
ClinicalTrials.gov Identifier:
NCT01507077
First received: January 5, 2012
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to assess the Pharmacokinetics/Pharmacodynamics (PK/PD), safety, and effectiveness of multiple subcutaneous doses of Beloranib (ZGN-440).


Condition Intervention Phase
Obesity
Drug: ZGN-440
Drug: ZGN-440 sterile diluent
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: ZGN-440 (Beloranib for Subcutaneous Injection), A Novel Methionine Aminopeptidase 2 Inhibitor for Treatment of Obesity: A Randomized Double-Blind Placebo Controlled Dose Escalation Phase 1b Trial to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Initial Weight Loss

Resource links provided by NLM:


Further study details as provided by Zafgen, Inc.:

Primary Outcome Measures:
  • Demonstrate safe doses of ZGN-440 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-440 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-440 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]
  • Elimination half-life of ZGN-440 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: December 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: ZGN-440 sterile diluent Drug: ZGN-440 sterile diluent
Subjects will receive placebo twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Experimental: ZGN-440 Drug: ZGN-440
Subjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
Other Name: Beloranib for subcutaneous injection

Detailed Description:

This protocol is designed to test the safety and efficacy of a drug called Beloranib (ZGN-440). 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-440 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 ≤ 45 kg/m2
  • Stable body weight during the past 2 months

Exclusion Criteria:

  • Use of weight loss agents in the past month
  • History of eating disorder
  • History of type 1 or type 2 diabetes mellitus
  • Current smokers
  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: NCT01507077

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: NCT01507077     History of Changes
Other Study ID Numbers: ZAF-101
Study First Received: January 5, 2012
Last Updated: July 17, 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 August 21, 2014