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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01372761 |
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Date of registration:
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08/06/2011 |
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Primary sponsor: |
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Public title:
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Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
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Scientific title:
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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 |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01372761 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Australia
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Contacts
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Name:
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J K Marjason, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Q-Pharm Clinics, Royal Brisbane and Women's Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Drug: Normal Saline
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Drug: ZGN-433
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Primary Outcome(s)
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Demonstrate safe doses of ZGN-433 for reduction of body weight in obese female volunteers.
[Time Frame: Approximately 4 weeks]
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Secondary Outcome(s)
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Elimination half-life of ZGN-433 to assess relationship to weight loss.
[Time Frame: Approximately 4 weeks]
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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.
[Time Frame: Approximately 4 weeks]
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Peak plasma concentration of ZGN-433 to assess relationship to weight loss.
[Time Frame: Approximately 4 weeks]
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Secondary ID(s)
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ZAF-003AUS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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