ZGN-440 (Beloranib for Subcutaneous Injection) for Treatment of Obesity
1 other identifier
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 obesity
Started Dec 2011
Shorter than P25 for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 5, 2012
CompletedFirst Posted
Study publicly available on registry
January 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJuly 18, 2012
July 1, 2012
3 months
January 5, 2012
July 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
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
Study Arms (2)
ZGN-440 sterile diluent
PLACEBO COMPARATORZGN-440
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Use of weight loss agents in the past month
- History of eating disorder
- History of type 1 or type 2 diabetes mellitus
- Current smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zafgen, Inc.lead
Study Sites (1)
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
J K Marjason, MD
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2012
First Posted
January 10, 2012
Study Start
December 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
July 18, 2012
Record last verified: 2012-07