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

Obesity Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study, to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZGN-433 in Obese Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028261
• Other study ID #: ZAF-001
• Status: Completed
• Phase: Phase 1
• First received: December 7, 2009
• Last updated: January 9, 2012
• Start date: December 2009
• Est. completion date: October 2010

Study information

• Verified date: January 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Zafgen, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Approximately 2 months	No
Secondary	Weight		Approximately 2 months	No