NCT02397499
Completed
Phase 3
A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat in Non-Obese Subjects
Overview
- Phase
- Phase 3
- Intervention
- LIPO-202
- Conditions
- Central Abdominal Bulging
- Sponsor
- Neothetics, Inc
- Enrollment
- 800
- Locations
- 31
- Primary Endpoint
- Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or non-pregnant female subjects
- •Capable of providing written consent.
- •BMI \< 30 kg/m2
- •Stable diet and exercise routine
- •Central abdominal bulging that is evaluated by the clinician at least slight bulge, not flat
Exclusion Criteria
- •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
Arms & Interventions
LIPO-202
Experimental arm
Intervention: LIPO-202
Placebo
Placebo comparator
Intervention: Placebo
Outcomes
Primary Outcomes
Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests.
Time Frame: 8 weeks
Physical examination, adverse events, vital signs, and laboratory tests.
Change in the clinician reported photonumeric score
Time Frame: 8 weeks post the start of treatment
Change in the patient reported global abdominal perception score
Time Frame: 8 weeks post the start of treatment
Secondary Outcomes
- Change in waist circumference(8 weeks post the start of treatment)
Study Sites (31)
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