Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
Phase 1b Trial of Beloranib, a Novel Methionine Aminopeptidase 2 (MetAP-2) Inhibitor for Treatment of Extreme Obesity: Randomized, Double-Blind, Placebo-Controlled, Escalating Doses in Female Volunteers
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to assess whether multiple doses of ZGN-433 are safe and effective.
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 Jun 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 8, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedDecember 30, 2011
December 1, 2011
5 months
June 8, 2011
December 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.
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 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-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
Study Arms (2)
Normal Saline
PLACEBO COMPARATORZGN-433
EXPERIMENTALInterventions
Subjects will receive placebo or ZGN-433 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 or ZGN-433 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 ≤ 50 kg/m2
- Stable body weight during the past month
You may not qualify if:
- Use of weight loss agents in the past month
- History of eating disorder
- History of gastric bypass surgery
- 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
June 8, 2011
First Posted
June 14, 2011
Study Start
June 1, 2011
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
December 30, 2011
Record last verified: 2011-12