Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat

NCT03005717 | Completed Phase 2

• 1 other identifier: LIPO-202-CL-31
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 11

Brief Summary

Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on submental bulging due to subcutaneous fat. Approximately 150 participants of either gender who have a "Moderate Bulge" or "Large Bulge" in the submental fat (on Patient-Reported Submental Bulging Scale \[PR-SBS\] and Clinician-Reported Submental Bulging Scale \[CR-SBS\]) will be recruited for this study.

Conditions

Submental Fat

Keywords

submental; Salmeterol Xinafoate; LIPO-202; bulge

Outcome Measures

Primary Outcomes (5)

• Safety as measured by number of subjects with adverse events.

  12 weeks (Baseline through 4 weeks post last dose)

• Safety as measured by the number of subjects with abnormal post baseline shifts in laboratory results.

  12 weeks (Baseline through 4 weeks post last dose)

• Change from baseline in the patient reported submental bulging scale.

  The self-rating scale is 5-point scale that the subject evaluates their submental fat.

  12 weeks (Baseline through 4 weeks post last dose)

• Change from baseline in the clinician reported submental bulging scale

  The clinician scale is 5-point rating scale in which the clinician evaluates the subject's submental fat.

  12 weeks (Baseline through 4 weeks post last dose)

• Change in submental fat thickness measured with calipers (mm).

  12 weeks (Baseline through 4 weeks post last dose)

Study Arms (3)

Active High

EXPERIMENTAL

Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.2 mcg SX/mL Total Weekly Dose: up to 3.0 mcg SX

Drug: LIPO-202

Active Low

EXPERIMENTAL

Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.02 mcg SX/mL Total Weekly Dose: up to 0.3 mcg SX

Drug: LIPO-202

Placebo

PLACEBO COMPARATOR

Placebo for LIPO 202 (Salmeterol Xinafoate for Injection)

Drug: Placebo for LIPO-202

Interventions

LIPO-202 DRUG

Also known as: Salmeterol Xinafoate for Injection

Active High; Active Low

Placebo for LIPO-202 DRUG

Lyophile manufactured to mimic LIPO-202 lyophile.

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or non-pregnant females;
• Capable of providing written, informed consent; and ,
• Have submental bulging that is evaluated by the Investigator as "Moderate" or "Large".

You may not qualify if:

• History of prior treatment to reduce submental bulging;
• History of derm fillers, chemical peels, or laser or radio frequency procedures in the neck/chin area within 12 months of screening;
• History of botulinum toxin in the neck/chin area within 6 months of screening;
• Any skin conditions (including, but not limited to: skin infections, psoriasis, eczema, keloids, tattoos or hypertrophic or tethered scars) or history of trauma in the treatment area that may affect study procedures;
• A score of 4 (Extreme Laxity) on the Skin Laxity Assessment Scale at Visit 1 (Screening);
• Any known hypersensitivity to the study drug and/or any of the components;
• Prior or current enrollment in any Lithera/Neothetics sponsored LIPO-102/LIPO-202 study;
• Concurrently enrolled in another investigational drug or device study or used any experimental or investigational drug or device within 30 days of screening;
• Female subject who is pregnant or lactating;
• Any medical condition that in the opinion of the Investigator might complicate study procedures or assessments or jeopardize the subject's safety, including, but not limited to:
• any bleeding or connective tissue disorders;
• any clinically significant kidney or liver disease;
• any untreated thyroid disease;
• asthma, COPD, diabetes (Type I and II) or cardiovascular disease
• history of major surgery within 30 days prior to randomization, or planned surgery during the study period;

Sponsors & Collaborators

• Neothetics, Inc: lead

Study Sites (11)

Clinical Testing of Beverly Hills

Beverly Hills, California, 90210, United States

Location

Ablon Skin Institute And Research Center

Manhattan Beach, California, 90266, United States

Location

AboutSkin Research

Greenwood Village, Colorado, 80113, United States

Location

Skin Research Institute

Coral Gables, Florida, 33146, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Mercy Research

Washington, Missouri, 63090, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Juva Skin & Laser Center

New York, New York, 10022, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Westlake Dermatology Clinical Research Center

Austin, Texas, 78746, United States

Location

MeSH Terms

Interventions

Salmeterol Xinafoate; Injections

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Daniel Piacquadio, MD

  Consultant, Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 29, 2016
• Study Start: December 22, 2016
• Primary Completion: June 2, 2017
• Study Completion: June 2, 2017
• Last Updated: October 20, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)