NCT01180465

Brief Summary

LIPO-102 is under evaluation for treatment of abdominal adiposity

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2010

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

August 10, 2010

Last Update Submit

March 5, 2015

Conditions

Weight

Keywords

Treatment of abdominal adiposity

Outcome Measures

Primary Outcomes (2)

  • 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

  • Change in abdominal circumference

    abdominal circumference

    8 weeks

Secondary Outcomes (4)

  • photographic assessment

    8 weeks

  • Abdominal subcutaneous adiposity questionnaire

    8 weeks

  • Patient and clinician photo numeric scale

    8 weeks

  • Patient global assessment of severity scale

    8 weeks

Study Arms (3)

LIPO-102 High

EXPERIMENTAL
Drug: LIPO-102

LIPO-102, Low

EXPERIMENTAL
Drug: LIPO-102 Low

LIPO-102; Placebo

PLACEBO COMPARATOR
Drug: LIPO-102, Placebo

Interventions

LIPO-102DRUG

LIPO-102 High dose

LIPO-102 High
LIPO-102 LowDRUG

LIPO-102 Low dose

LIPO-102, Low
LIPO-102, PlaceboDRUG

Placebo

LIPO-102; Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Prior treatment of abdominal subcutaneous adipose tissue
  • Females within 12 months postpardum
  • Known hypersensitivity to the drugs or components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

New York, New York, United States

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2010

First Posted

August 12, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(2)