Dose Ranging and Dose Frequency of LIPO-102
A Dose-Ranging and Dose Frequency Study Evaluating the Safety and Efficacy of LIPO-102 for the Reduction of Abdominal Subcutaneous Adipose Tissue
1 other identifier
interventional
54
1 country
2
Brief Summary
Dose Ranging and Dose Frequency of LIPO-102
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2009
Shorter than P25 for phase_2
2 active sites
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, 2009
CompletedFirst Submitted
Initial submission to the registry
June 10, 2009
CompletedFirst Posted
Study publicly available on registry
June 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMarch 6, 2015
February 1, 2015
8 months
June 10, 2009
February 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety: physical examinations, laboratory tests, AE assessment
4 weeks treatment and 4 weeks follow up
Secondary Outcomes (1)
Efficacy: change in subcutaneous abdominal adipose tissue thickness
4 weeks treatment and 4 weeks follow up
Study Arms (2)
LIPO-102
EXPERIMENTALLIPO-102
Placebo
EXPERIMENTALPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or non pregnant female
- Good general health
- Sufficient abdominal fat for injections
- Signed informed consent
You may not qualify if:
- Known hypersensitivity to study drugs
- Treatment with an investigational agent within 30 days of first dose
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neothetics, Inclead
Study Sites (2)
Unknown Facility
San Diego, California, United States
Unknown Facility
Baltimore, Maryland, United States
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2009
First Posted
June 11, 2009
Study Start
June 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
March 6, 2015
Record last verified: 2015-02