Dose Ranging Study

Phase 2CompletedNCT01802723

Neothetics, Inc472 enrolled

Overview

Dose Ranging Study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

472

Conditions

Periumbilical Subcutaneous Adipose Tissue Reduction

Interventions

Drug: salmeterol xinafoateDRUG

Drug: PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (22)

United States, California

Beverly Hills, California, United States

United States, California

Outcomes

Primary Outcomes

Safety

physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events

Time frame: 8 weeks treatment

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)

abdominal circumference

Time frame: 9 weeks

Secondary Outcomes

Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)

Time frame: 9 weeks

Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)

Time frame: 9 weeks

Data from ClinicalTrials.gov

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