Phase 3
N=793
Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
Central Abdominal Bulging
Bottom Line
View on ClinicalTrials.gov: NCT02398188 ↗Enrolled (actual)
793
Serious AEs
0.3%
Results posted
Jan 2019
Primary outcome: Primary: Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response — 37; 48 Participants — p=0.397
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LIPO-202 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Evofem Inc.
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response |
37; 48 | 0.397 |
| PRIMARY Percent Change in the Patient Reported Global Abdominal Perception Score |
202; 175 | 0.379 |
| SECONDARY Percent Change in Waist Circumference |
24.1; 24.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02398188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.