Dose Ranging and Dose Frequency of LIPO-102 | NCT00918814

Studies
Dose Ranging and Dose Frequency of LIPO-102

NCT00918814

Sponsor

Neothetics, Inc

Status

Completed

Last Update Posted

Mar 6, 2015Estimated

Enrollment

54Actual

Phase

Phase 2

Conditions

Subcutaneous Adipose Tissue Reduction

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

Feb 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

Jun 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jun 10, 2009

First Submission Date that Met QC Criteria

Jun 10, 2009

First Posted Date

Jun 11, 2009Estimated

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

Feb 17, 2015

Certification/Extension First Submitted that Passed QC Review

Feb 17, 2015

Certification/Extension First Posted Date

Mar 6, 2015Estimated

Last Update Submitted Date

Feb 17, 2015

Last Update Posted Date

Mar 6, 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

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

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LIPO-102	Experimental	LIPO-102	Drug: LIPO-102
Placebo	Experimental	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LIPO-102	Drug	Subcutaneous Injection	LIPO-102
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: physical examinations, laboratory tests, AE assessment		4 weeks treatment and 4 weeks follow up

Secondary Outcomes

Measure	Description	Time Frame
Efficacy: change in subcutaneous abdominal adipose tissue thickness		4 weeks treatment and 4 weeks follow up

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

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
		San Diego	California		United States