Periumbilical Subcutaneous Adipose Tissue Reduction
Conditions
Brief summary
Dose Ranging Study
Interventions
DRUGDrug: salmeterol xinafoate
DRUGDrug: Placebo
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
Yes
Inclusion criteria
\>18 years of age inclusive Subcutaneous fat in the periumbilical area BMI \<30 kg/msq Stable diet and exercise and body weight
Exclusion criteria
Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 8 weeks treatment | physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events |
| Change in global clinician abdominal perception scale score (baseline and 9 weeks) | 9 weeks | — |
| Change in global patient abdominal perception scale score (baseline and 9 weeks) | 9 weeks | — |
| Change in abdominal circumference (baseline and 9 weeks) | 9 weeks | abdominal circumference |
Secondary
| Measure | Time frame |
|---|---|
| Change in Photonumeric abdominal perception scale score (baseline and 9 weeks) | 9 weeks |
| Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks) | 9 weeks |
Other
| Measure | Time frame |
|---|---|
| Change in subcutaneous abdominal adipose tissue thickness (baseline and 9 weeks) | 9 weeks |
Countries
United States
Outcome results
None listed