Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Central Abdominal Bulging

Intervention / Treatment
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* Drug: LIPO-202
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIPO-202<br>Experimental arm | Drug: LIPO-202<br> <br> * Other names: Salmeterol;|
| Placebo Comparator: Placebo<br>Placebo comparator | Drug: Placebo<br> <br> * Other names: Placebo for LIPO-202;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response | The composite P-GAPS1/CPnS2 response was defined as at least a 1 point (grade) improvement in P-GAPS and at least a 2 point (grade) improvement in CPnS from baseline after 8 weeks of treatment. Patient - Global Abdominal Perception Scale (P-GAPS) - a patient views and assesses the contour of their abdomen on a 5-point verbal scale ranging from Flat to Big Bulge. Clinician Photonumeric Scale (CPnS) - a trained clinician rater examines the subject's abdomen and matches the subject's abdominal bulge/profile to the nearest gender-specific abdominal photo on the 6-point scale. | Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment) | 
| Percent Change in the Patient Reported Global Abdominal Perception Score | 1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome. | 8 weeks post the start of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Waist Circumference |  | 8 weeks post the start of treatment |