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

A Double-Masked, Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01096979

Enrollment

Registered

2010-03-31

Start date

2009-10-31

Completion date

2010-03-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subcutaneous Abdominal Adiposity

Keywords

Subcutaneous Adipose Tissue Reduction

Brief summary

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

Interventions

DRUGLIPO-102

subcutaneous injection

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	8 weeks	Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events.
Reduction in abdominal adiposity	8 weeks	—
Waist circumference	8 weeks	—

Secondary

Measure	Time frame	Description
Patient and clinician global impression of change questions	8 weeks	—
Photographic assessments	8 weeks	Abdominal volume reductions
Abdominal appearance questionnaire	8 weeks	—
Skin-fold caliper measurements	8 weeks	—
Patient and clinician Global Impression of severity survey	8 weeks	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026