A Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity

Phase 2CompletedNCT01180465

Neothetics, Inc160 enrolled

Overview

LIPO-102 is under evaluation for treatment of abdominal adiposity

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Weight

Interventions

LIPO-102DRUG

LIPO-102 High dose

LIPO-102 LowDRUG

LIPO-102 Low dose

LIPO-102, PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18 - 50 years old inclusive * Localized area of abdominal subcutaneous adiposity of Grade 3 or above on the P-PNS or C-PNS * BMI \< 25kg/m sq * Stable diet and exercise and body weight Exclusion Criteria: * Prior treatment of abdominal subcutaneous adipose tissue * Females within 12 months postpardum * Known hypersensitivity to the drugs or components

Locations (2)

Unnamed facility

San Diego, California, United States

Unnamed facility

New York, New York, United States

Outcomes

Primary Outcomes

Safety

physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events

Time frame: 8 weeks treatment and 1 week follow up

Change in abdominal circumference

abdominal circumference

Time frame: 8 weeks

Secondary Outcomes

photographic assessment

abdominal circumference and volume reduction assessment

Time frame: 8 weeks

Abdominal subcutaneous adiposity questionnaire

Patient reported outcome

Time frame: 8 weeks

Patient and clinician photo numeric scale

patient and physician reports of change

Time frame: 8 weeks

Patient global assessment of severity scale

patient reports of change in severity

Time frame: 8 weeks

Data from ClinicalTrials.gov

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