NCT01802723

Brief Summary

Dose Ranging Study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
472

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

22 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

February 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

February 26, 2013

Last Update Submit

March 5, 2015

Conditions

Periumbilical Subcutaneous Adipose Tissue Reduction

Outcome Measures

Primary Outcomes (4)

  • Safety

    physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events

    8 weeks treatment

  • Change in global clinician abdominal perception scale score (baseline and 9 weeks)

    9 weeks

  • Change in global patient abdominal perception scale score (baseline and 9 weeks)

    9 weeks

  • Change in abdominal circumference (baseline and 9 weeks)

    abdominal circumference

    9 weeks

Secondary Outcomes (2)

  • Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)

    9 weeks

  • Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)

    9 weeks

Other Outcomes (1)

  • Change in subcutaneous abdominal adipose tissue thickness (baseline and 9 weeks)

    9 weeks

Study Arms (4)

LIPO-202, Low

EXPERIMENTAL

Drug: salmeterol xinafoate

Drug: Drug: salmeterol xinafoate

LIPO-202, Mid

EXPERIMENTAL

Drug: salmeterol xinafoate

Drug: Drug: salmeterol xinafoate

LIPO-202, High

EXPERIMENTAL

Drug: salmeterol xinafoate

Drug: Drug: salmeterol xinafoate

LIPO-202, Placebo

EXPERIMENTAL

Drug: Placebo

Drug: Drug: Placebo

Interventions

Drug: salmeterol xinafoateDRUG
Also known as: LIPO-202, Salmeterol
LIPO-202, HighLIPO-202, LowLIPO-202, Mid
Drug: PlaceboDRUG
Also known as: Placebo
LIPO-202, Placebo

Eligibility Criteria

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

You may qualify if:

  • \>18 years of age inclusive Subcutaneous fat in the periumbilical area BMI \<30 kg/msq Stable diet and exercise and body weight

You may not qualify if:

  • Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

United States, California

Beverly Hills, California, United States

Location

United States, California

Encinitas, California, United States

Location

United States, California

Los Angeles, California, United States

Location

United States, California

San Diego, California, United States

Location

United States, California

Santa Ana, California, United States

Location

United States, Florida

Aventura, Florida, United States

Location

United States, Florida

Clearwater, Florida, United States

Location

United States, Florida

Lake Worth, Florida, United States

Location

United States, Florida

Miami, Florida, United States

Location

United States, Florida

Tampa, Florida, United States

Location

United States, Illinois

Buffalo Grove, Illinois, United States

Location

United States, Illinois

Chicago, Illinois, United States

Location

United States, New York

New York, New York, United States

Location

United States, New York

Smithtown, New York, United States

Location

United States, North Carolina

Chapel Hill, North Carolina, United States

Location

United States, North Carolina

Raleigh, North Carolina, United States

Location

United States, Tennessee

Nashville, Tennessee, United States

Location

United States, Texas

Austin, Texas, United States

Location

United States, Texas

Dallas, Texas, United States

Location

United States, Texas

Fort Worth, Texas, United States

Location

United States, Texas

Houston, Texas, United States

Location

United States, Texas

Plano, Texas, United States

Location

MeSH Terms

Interventions

Salmeterol Xinafoate

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Murray C Maytom, MBChB, MBA

    Neothetics, Inc

    STUDY DIRECTOR

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

February 26, 2013

First Posted

March 1, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

October 1, 2013

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(22)