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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: ZGN-440 sterile diluent; Drug: ZGN-440

• Registration Number: NCT01507077
• Lead Sponsor: Zafgen, Inc.

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).

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

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 ≤ 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ZGN-440 sterile diluent	ZGN-440 sterile diluent	-
ZGN-440	ZGN-440	-

Primary Outcome Measures

Name	Time	Method
Demonstrate safe doses of ZGN-440 for reduction of body weight in obese female volunteers.	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

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-440 to assess relationship to weight loss.	Approximately 4 weeks
Elimination half-life of ZGN-440 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