NCT01802723CompletedPhase 2
A Dose Ranging Study of the Safety and Efficacy of LIPO-202 Healthy Patients With Subcutaneous Fat in the Periumbilical Area
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Neothetics, Inc
- Enrollment
- 472
- Locations
- 22
- Primary Endpoint
- Safety
Study Overview
Brief Summary
Dose Ranging Study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
LIPO-202, High
Experimental
Drug: salmeterol xinafoate
Intervention: Drug: salmeterol xinafoate (Drug)
LIPO-202, Placebo
Experimental
Drug: Placebo
Intervention: Drug: Placebo (Drug)
LIPO-202, Mid
Experimental
Drug: salmeterol xinafoate
Intervention: Drug: salmeterol xinafoate (Drug)
LIPO-202, Low
Experimental
Drug: salmeterol xinafoate
Intervention: Drug: salmeterol xinafoate (Drug)
Outcomes
Primary Outcomes
Safety
Time Frame: 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)
Time Frame: 9 weeks
Change in global patient abdominal perception scale score (baseline and 9 weeks)
Time Frame: 9 weeks
Change in abdominal circumference (baseline and 9 weeks)
Time Frame: 9 weeks
abdominal circumference
Secondary Outcomes
- Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)(9 weeks)
- Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)(9 weeks)
Investigators
Study Sites (22)
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