Dose Ranging Study | Clinical Trial

Key information

Conditions

Periumbilical Subcutaneous Adipose Tissue Reduction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

United States, California, Beverly Hills, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Drug: salmeterol xinafoate

Drug

Other names: LIPO-202, Salmeterol

Drug: Placebo

Drug

Other names: Placebo

Primary outcomes

Safety

Time frame: 8 weeks treatment

physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
Change in global clinician abdominal perception scale score (baseline and 9 weeks)

Time frame: 9 weeks
Change in global patient abdominal perception scale score (baseline and 9 weeks)

Time frame: 9 weeks
Change in abdominal circumference (baseline and 9 weeks)

Time frame: 9 weeks

abdominal circumference

Secondary outcomes

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

Time frame: 9 weeks
Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)

Time frame: 9 weeks

Other outcomes

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

Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

Neothetics, Inc

Industry

Registry information

Official study title

A Dose Ranging Study of the Safety and Efficacy of LIPO-202 Healthy Patients With Subcutaneous Fat in the Periumbilical Area

Acronym: RESET

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Mar 1, 2013
Registry last updated: Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.