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

• ClinicalTrials.gov Identifier: NCT03005717
• Recruitment Status: Completed
• First Posted: December 29, 2016
• Last Update Posted: October 20, 2017
• Sponsor: Neothetics, Inc
• Information provided by (Responsible Party): Neothetics, Inc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Submental Fat	Drug: LIPO-202; Drug: Placebo for LIPO-202	Phase 2

Detailed Description:

Potential subjects will present and complete the Screening Visit. All qualifying subjects will be randomized to one of three treatment groups and treated with up to 30 subcutaneous injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon completion of treatment visits, subject will return to the clinic for a follow-up visit and end of study visit, one and four weeks after the last treatment. The number and pattern of injections will be based on the area (cm x cm) of submental fat at baseline. At each visit the subjects will also undergo an examination of the treatment area, collection of vital signs and questioning about possible adverse events (AEs).

The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit and an End of Study Visit.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of LIPO-202 (Salmeterol Xinafoate for Injection) for the Reduction of Submental Subcutaneous Fat
• Actual Study Start Date: December 22, 2016
• Actual Primary Completion Date: June 2, 2017
• Actual Study Completion Date: June 2, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active High; Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.2 mcg SX/mL Total Weekly Dose: up to 3.0 mcg SX	Drug: LIPO-202; Other Name: Salmeterol Xinafoate for Injection
Experimental: Active Low; Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.02 mcg SX/mL Total Weekly Dose: up to 0.3 mcg SX	Drug: LIPO-202; Other Name: Salmeterol Xinafoate for Injection
Placebo Comparator: Placebo; Placebo for LIPO 202 (Salmeterol Xinafoate for Injection)	Drug: Placebo for LIPO-202; Lyophile manufactured to mimic LIPO-202 lyophile.; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Safety as measured by number of subjects with adverse events. [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]
2. Safety as measured by the number of subjects with abnormal post baseline shifts in laboratory results. [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]
3. Change from baseline in the patient reported submental bulging scale. [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]
   The self-rating scale is 5-point scale that the subject evaluates their submental fat.
4. Change from baseline in the clinician reported submental bulging scale [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]
   The clinician scale is 5-point rating scale in which the clinician evaluates the subject's submental fat.
5. Change in submental fat thickness measured with calipers (mm). [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. History of prior treatment to reduce submental bulging;
2. History of derm fillers, chemical peels, or laser or radio frequency procedures in the neck/chin area within 12 months of screening;
3. History of botulinum toxin in the neck/chin area within 6 months of screening;
4. 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;
5. A score of 4 (Extreme Laxity) on the Skin Laxity Assessment Scale at Visit 1 (Screening);
6. Any known hypersensitivity to the study drug and/or any of the components;
7. Prior or current enrollment in any Lithera/Neothetics sponsored LIPO-102/LIPO-202 study;
8. Concurrently enrolled in another investigational drug or device study or used any experimental or investigational drug or device within 30 days of screening;
9. Female subject who is pregnant or lactating;

10. 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:

    1. any bleeding or connective tissue disorders;
    2. any clinically significant kidney or liver disease;
    3. any untreated thyroid disease;
    4. asthma, COPD, diabetes (Type I and II) or cardiovascular disease
    5. history of major surgery within 30 days prior to randomization, or planned surgery during the study period;
11. Used drugs with anticoagulant activity (including aspirin) within 14 days prior to randomization, β adrenergic receptor agonists or blockers, strong CYP3A inhibitors, or nonpotassium sparing diuretics (e.g., loop or thiazide diuretics) within 28 days prior to randomization;
12. Used tricyclic antidepressants or monoamine oxidase inhibitor medications within 14 days prior to randomization;
13. Unlikely or unable to adhere to the study visit schedule or comply with protocol procedures.

Contacts and Locations

Locations

United States, California

Clinical Testing of Beverly Hills

Beverly Hills, California, United States, 90210

Ablon Skin Institute And Research Center

Manhattan Beach, California, United States, 90266

United States, Colorado

AboutSkin Research

Greenwood Village, Colorado, United States, 80113

United States, Florida

Skin Research Institute

Coral Gables, Florida, United States, 33146

United States, Michigan

Grekin Skin Institute

Warren, Michigan, United States, 48088

United States, Minnesota

Minnesota Clinical Study Center

Fridley, Minnesota, United States, 55432

United States, Missouri

Mercy Research

Washington, Missouri, United States, 63090

United States, Nebraska

Skin Specialists, PC

Omaha, Nebraska, United States, 68144

United States, New York

Juva Skin & Laser Center

New York, New York, United States, 10022

United States, Tennessee

Tennessee Clinical Research Center

Nashville, Tennessee, United States, 37215

United States, Texas

Westlake Dermatology Clinical Research Center

Austin, Texas, United States, 78746

Sponsors and Collaborators

Neothetics, Inc

Investigators

• Study Chair: Daniel Piacquadio, MD; Consultant, Therapeutics, Inc.

More Information

• Responsible Party: Neothetics, Inc
• ClinicalTrials.gov Identifier: NCT03005717
• Other Study ID Numbers: LIPO-202-CL-31
• First Posted: December 29, 2016
• Last Update Posted: October 20, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Neothetics, Inc:

submental; Salmeterol Xinafoate; LIPO-202; bulge

Additional relevant MeSH terms:

Salmeterol Xinafoate; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action