An Open-Label Study to Evaluate Retreatment With LIPO-202 | NCT02397525

Studies
An Open-Label Study to Evaluate Retreatment With LIPO-202

NCT02397525

Sponsor

Neothetics, Inc

Status

Unknown status

Last Update Posted

Aug 13, 2015Estimated

Enrollment

150Estimated

Phase

Phase 2

Conditions

Central Abdominal Bulging

Interventions

LIPO-202

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

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Not provided

First Submitted Date

Mar 19, 2015

First Submission Date that Met QC Criteria

Mar 19, 2015

First Posted Date

Mar 25, 2015Estimated

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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2015

Last Update Posted Date

Aug 13, 2015Estimated

Description Module

Brief Summary

Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.

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

150Estimated

Label	Type	Description	Intervention Names
LIPO-202	Experimental		Drug: LIPO-202

Name	Type	Description	Arm Group Labels	Other Names
LIPO-202	Drug		LIPO-202

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: vital signs, physical exams, laboratory tests		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provided consent
Healthy male or non-pregnant female subjects
BMI < 30 kg/m2
Stable diet and exercise routine
Central abdominal bulging that is at least "Slight Bulge, Not Flat"

Exclusion Criteria:

Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen
Plan on starting a weight loss or exercise program during the study.
Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control.
Known hypersensitivity to study drugs
Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maria Feldman	Neothetics, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AboutSkin Dermatology		Englewood	Colorado	80113	United States
Dermatology Research Institute, LLC