Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Salmeterol
LIPO-202 · 1 trial · 1 indication
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.
1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.
| Arm | Type | Description |
|---|---|---|
| LIPO-202 | EXPERIMENTAL | Experimental arm |
| Placebo | PLACEBO_COMPARATOR | Placebo comparator |
| Name | Type | Description |
|---|---|---|
| LIPO-202 | DRUG | - |
| Placebo | DRUG | - |
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 treatme...