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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507077
• Other study ID #: ZAF-101
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2012
• Last updated: July 17, 2012
• Start date: December 2011
• Est. completion date: March 2012

Study information

• Verified date: July 2012
• Source: Zafgen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Australia	Q-Pharm Clinics, Royal Brisbane and Women's Hospital	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Zafgen, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate safe doses of ZGN-440 for reduction of body weight in obese female volunteers.	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.	Approximately 4 weeks	No
Secondary	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.		Approximately 4 weeks	No
Secondary	Peak plasma concentration of ZGN-440 to assess relationship to weight loss.		Approximately 4 weeks	No
Secondary	Elimination half-life of ZGN-440 to assess relationship to weight loss.		Approximately 4 weeks	No