Dose Ranging Study (RESET)

Neothetics

Status and phase: Completed; Phase 2

Conditions: Periumbilical Subcutaneous Adipose Tissue Reduction

Treatments: Drug: Drug: Placebo; Drug: Drug: salmeterol xinafoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01802723

LIPO-202-CL-16

Details and patient eligibility

About

Dose Ranging Study

Enrollment: 472 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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472 participants in 4 patient groups

LIPO-202, Low

Experimental group

Description:

Drug: salmeterol xinafoate

Treatment:

Drug: Drug: salmeterol xinafoate

LIPO-202, Mid

Experimental group

Description:

Drug: salmeterol xinafoate

Treatment:

Drug: Drug: salmeterol xinafoate

LIPO-202, High

Experimental group

Description:

Drug: salmeterol xinafoate

Treatment:

Drug: Drug: salmeterol xinafoate

LIPO-202, Placebo

Experimental group

Description:

Drug: Placebo

Treatment:

Drug: Drug: Placebo