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

Weight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180465
• Other study ID #: LIPO-102-CL-09
• Secondary ID: LIPO-102-CL-09
• Status: Completed
• Phase: Phase 2
• First received: August 10, 2010
• Last updated: March 5, 2015
• Start date: April 2010
• Est. completion date: September 2010

Study information

• Verified date: March 2015
• Source: Neothetics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

LIPO-102 is under evaluation for treatment of abdominal adiposity

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Weight

Intervention

Drug:
• LIPO-102
LIPO-102 High dose
• LIPO-102 Low
LIPO-102 Low dose
• LIPO-102, Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neothetics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events	8 weeks treatment and 1 week follow up	No
Primary	Change in abdominal circumference	abdominal circumference	8 weeks	No
Secondary	photographic assessment	abdominal circumference and volume reduction assessment	8 weeks	No
Secondary	Abdominal subcutaneous adiposity questionnaire	Patient reported outcome	8 weeks	No
Secondary	Patient and clinician photo numeric scale	patient and physician reports of change	8 weeks	No
Secondary	Patient global assessment of severity scale	patient reports of change in severity	8 weeks	No