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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: Normal Saline; Drug: ZGN-433

• Registration Number: NCT01372761
• Lead Sponsor: Zafgen, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-10
• Study First Posted: 2011-06-14
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-28
• Last Update Posted: 2011-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	-
ZGN-433	ZGN-433	-

Primary Outcome Measures

Name	Time	Method
Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.	Approximately 4 weeks	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

Name	Time	Method
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
Peak plasma concentration of ZGN-433 to assess relationship to weight loss.	Approximately 4 weeks
Elimination half-life of ZGN-433 to assess relationship to weight loss.	Approximately 4 weeks

Trial Locations

Locations (1)

Q-Pharm Clinics, Royal Brisbane and Women's Hospital; 🇦🇺 Brisbane, Queensland, Australia