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
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
No
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 |
|---|---|---|
| Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests. | 8 weeks | Physical examination, adverse events, vital signs, and laboratory tests. |
| Change in the clinician reported photonumeric score | 8 weeks post the start of treatment | — |
| Change in the patient reported global abdominal perception score | 8 weeks post the start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in waist circumference | 8 weeks post the start of treatment |
Countries
United States
Outcome results
None listed