An Evaluation of the Safety and Efficacy of LIPO-102 for... | NCT01096979

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

NCT01096979

Sponsor

Neothetics, Inc

Status

Completed

Last Update Posted

Mar 26, 2015Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Subcutaneous Abdominal Adiposity

Interventions

LIPO-102
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Oct 16, 2009

First Submission Date that Met QC Criteria

Mar 30, 2010

First Posted Date

Mar 31, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 5, 2015

Certification/Extension First Submitted that Passed QC Review

Mar 5, 2015

Certification/Extension First Posted Date

Mar 26, 2015Estimated

Last Update Submitted Date

Mar 5, 2015

Last Update Posted Date

Mar 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
LIPO-102	Drug	subcutaneous injection	LIPO-102, High LIPO-102, Low

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Photographic assessments	Abdominal volume reductions	8 weeks
Skin-fold caliper measurements		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Anaheim	California		United States