An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity

Neothetics, Inc60 enrolled

Overview

This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Subcutaneous Abdominal Adiposity

Interventions

LIPO-102DRUG

subcutaneous injection

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or non pregnant female * Good general health * Sufficient abdominal fat for injections * Signed informed consent * BMI greater than or equal to 18 and less than 28 kg/m2 * History of stable weight in past 3 months Exclusion Criteria: * Known hypersensitivity to study drugs * Treatment with an investigational agent within 30 days of first dose

Locations (2)

Unnamed facility

Anaheim, California, United States

Unnamed facility

San Diego, California, United States

Outcomes

Primary Outcomes

Safety

Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events.

Time frame: 8 weeks

Reduction in abdominal adiposity

Time frame: 8 weeks

Waist circumference

Time frame: 8 weeks

Secondary Outcomes

Photographic assessments

Abdominal volume reductions

Time frame: 8 weeks

Skin-fold caliper measurements

Time frame: 8 weeks

Patient and clinician Global Impression of severity survey

Time frame: 8 weeks

Patient and clinician global impression of change questions

Time frame: 8 weeks

Abdominal appearance questionnaire

Time frame: 8 weeks

Data from ClinicalTrials.gov

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