NCT01096979

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

October 16, 2009

Last Update Submit

March 5, 2015

Conditions

Subcutaneous Abdominal Adiposity

Keywords

Subcutaneous Adipose Tissue Reduction

Outcome Measures

Primary Outcomes (3)

  • Safety

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

    8 weeks

  • Reduction in abdominal adiposity

    8 weeks

  • Waist circumference

    8 weeks

Secondary Outcomes (5)

  • Photographic assessments

    8 weeks

  • Skin-fold caliper measurements

    8 weeks

  • Patient and clinician Global Impression of severity survey

    8 weeks

  • Patient and clinician global impression of change questions

    8 weeks

  • Abdominal appearance questionnaire

    8 weeks

Study Arms (3)

LIPO-102, High

EXPERIMENTAL

LIPO-102, High

Drug: LIPO-102

LIPO-102, Low

EXPERIMENTAL

LIPO-102, Low

Drug: LIPO-102

Placebo

EXPERIMENTAL

Pbo

Drug: Placebo

Interventions

LIPO-102DRUG

subcutaneous injection

LIPO-102, HighLIPO-102, Low
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Known hypersensitivity to study drugs
  • Treatment with an investigational agent within 30 days of first dose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Anaheim, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

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

October 16, 2009

First Posted

March 31, 2010

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(2)