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

A Multi-center, Randomized, Double-masked, Placebo-controlled, Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01180465

Enrollment

160

Registered

2010-08-12

Start date

2010-04-30

Completion date

2010-09-30

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

Weight

Keywords

Treatment of abdominal adiposity

Brief summary

LIPO-102 is under evaluation for treatment of abdominal adiposity

Interventions

DRUGLIPO-102

LIPO-102 High dose

DRUGLIPO-102 Low

LIPO-102 Low dose

DRUGLIPO-102, Placebo

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 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	8 weeks treatment and 1 week follow up	physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events
Change in abdominal circumference	8 weeks	abdominal circumference

Secondary

Measure	Time frame	Description
photographic assessment	8 weeks	abdominal circumference and volume reduction assessment
Abdominal subcutaneous adiposity questionnaire	8 weeks	Patient reported outcome
Patient and clinician photo numeric scale	8 weeks	patient and physician reports of change
Patient global assessment of severity scale	8 weeks	patient reports of change in severity

Countries

United States

Outcome results

None listed

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