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

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ClinicalTrials.gov Identifier: NCT01507077
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : July 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Drug: ZGN-440 Drug: ZGN-440 sterile diluent Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Demonstrate safe doses of ZGN-440 for reduction of body weight in obese female volunteers. [ Time Frame: Approximately 4 weeks ]
    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 :
  1. 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 ]
  2. Peak plasma concentration of ZGN-440 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ]
  3. Elimination half-life of ZGN-440 to assess relationship to weight loss. [ Time Frame: Approximately 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Zafgen, Inc.
ClinicalTrials.gov Identifier: NCT01507077     History of Changes
Other Study ID Numbers: ZAF-101
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by Zafgen, Inc.:
Obese
Obesity
Overweight

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