Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects
A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging in a Defined Special Population - Obese Subjects (BMI > or Equal to 30 kg/m2)
1 other identifier
interventional
120
1 country
6
Brief Summary
This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
6 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
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 2, 2015
CompletedFirst Posted
Study publicly available on registry
October 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedDecember 24, 2015
October 1, 2015
3 months
October 2, 2015
December 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety as measured by physical examination, adverse events, vital signs, and laboratory tests.
Physical examination, adverse events, vital signs, and laboratory tests.
9 weeks
Secondary Outcomes (1)
Change in waist circumference.
9 weeks
Study Arms (2)
LIPO-202
EXPERIMENTALExperimental arm
Placebo
PLACEBO COMPARATORPlacebo comparator
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male or non-pregnant female subjects
- Capable of providing written consent
- BMI \> 30 kg/m2 but \< 40 kg/m2
- Stable diet and exercise routine
- At least "Slightly Dissatisfied" with their abdominal bulging on the Abdominal Contour Questionnaire (ACQ)
You may not qualify if:
- BMI \> 40 kg/m2
- Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
- Plan on starting a weight loss or exercise program during the study
- Known hypersensitivity to study drugs
- Have any medical condition that might complicate study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neothetics, Inclead
Study Sites (6)
Diagnamics, Inc.
Encinitas, California, 92024, United States
Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266, United States
The Center for Clinical & Cosmetic Research
Aventura, Florida, 33180, United States
Skin Research Institute
Coral Gables, Florida, 33146, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Charlottesville Medical Research Center
Charlottesville, Virginia, 22911, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maria Feldman
Neothetics, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
October 2, 2015
First Posted
October 5, 2015
Study Start
September 1, 2015
Primary Completion
December 1, 2015
Last Updated
December 24, 2015
Record last verified: 2015-10