Pharmacokinetics, Safety, Tolerability and Efficacy of Intravenous Doses of ZGN-433 in Obese Female Volunteers
NCT ID: NCT01372761
Last Updated: 2011-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2011-06-30
2011-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Normal Saline
Normal Saline
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.
ZGN-433
ZGN-433
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ZGN-433
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.
Normal Saline
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* History of eating disorder
* History of gastric bypass surgery
* Current smokers
18 Years
60 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zafgen, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
J K Marjason, MD
Role: PRINCIPAL_INVESTIGATOR
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Q-Pharm Clinics, Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZAF-003AUS
Identifier Type: -
Identifier Source: org_study_id