Central Abdominal Bulging
Conditions
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.
Interventions
DRUGLIPO-202
DRUGPlacebo
Sponsors
Neothetics, Inc
Evofem Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response | Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment) | 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. |
| Percent Change in the Patient Reported Global Abdominal Perception Score | 8 weeks post the start of treatment | 1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome. |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change in Waist Circumference | 8 weeks post the start of treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LIPO-202 Experimental arm
LIPO-202 | 398 |
| Placebo Placebo comparator
Placebo | 395 |
| Total | 793 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Lost to Follow-up | 5 | 0 |
| Overall Study | Non-compliance | 4 | 4 |
| Overall Study | Pregnancy | 1 | 0 |
| Overall Study | Protocol Violation | 6 | 10 |
| Overall Study | Sponsor Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 16 |
Baseline characteristics
| Characteristic | LIPO-202 | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 11.7 | 40 years STANDARD_DEVIATION 11.9 | 41 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 83 Participants | 161 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 315 Participants | 632 Participants | 317 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants | 41 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants | 73 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants | 30 Participants | 13 Participants |
| Race (NIH/OMB) White | 316 Participants | 641 Participants | 325 Participants |
| Region of Enrollment United States | 398 participants | 793 participants | 395 participants |
| Sex: Female, Male Female | 327 Participants | 661 Participants | 334 Participants |
| Sex: Female, Male Male | 71 Participants | 132 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 398 | 0 / 395 |
| other Total, other adverse events | 138 / 398 | 150 / 395 |
| serious Total, serious adverse events | 1 / 398 | 1 / 395 |
Outcome results
Primary
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.
Time frame: Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment)
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LIPO-202 | Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response | 37 Participants |
| Placebo | Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response | 48 Participants |
p-value: 0.397Cochran-Mantel-Haenszel
Primary
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.
Time frame: 8 weeks post the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LIPO-202 | Percent Change in the Patient Reported Global Abdominal Perception Score | 202 percent change | Standard Deviation 51 |
| Placebo | Percent Change in the Patient Reported Global Abdominal Perception Score | 175 percent change | Standard Deviation 44 |
p-value: 0.379Cochran-Mantel-Haenszel
Secondary
Percent Change in Waist Circumference
Time frame: 8 weeks post the start of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LIPO-202 | Percent Change in Waist Circumference | 24.1 percent change | Standard Deviation 2.65 |
| Placebo | Percent Change in Waist Circumference | 24.2 percent change | Standard Deviation 2.66 |