Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat
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ClinicalTrials.gov Identifier: NCT03005717 |
Recruitment Status :
Completed
First Posted : December 29, 2016
Last Update Posted : October 20, 2017
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Condition or disease | Intervention/treatment | Phase |
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Submental Fat | Drug: LIPO-202 Drug: Placebo for LIPO-202 | Phase 2 |
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 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 |

Arm | Intervention/treatment |
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Experimental: Active High
Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.2 mcg SX/mL Total Weekly Dose: up to 3.0 mcg SX
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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
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Drug: LIPO-202
Other Name: Salmeterol Xinafoate for Injection |
Placebo Comparator: Placebo
Placebo for LIPO 202 (Salmeterol Xinafoate for Injection)
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Drug: Placebo for LIPO-202
Lyophile manufactured to mimic LIPO-202 lyophile.
Other Name: Placebo |
- Safety as measured by number of subjects with adverse events. [ Time Frame: 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. [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]
- 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.
- 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.
- Change in submental fat thickness measured with calipers (mm). [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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".
Exclusion Criteria:
- 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;
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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;
- 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;
- Used tricyclic antidepressants or monoamine oxidase inhibitor medications within 14 days prior to randomization;
- Unlikely or unable to adhere to the study visit schedule or comply with protocol procedures.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005717
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 |
Study Chair: | Daniel Piacquadio, MD | Consultant, Therapeutics, Inc. |
Responsible Party: | Neothetics, Inc |
ClinicalTrials.gov Identifier: | NCT03005717 |
Other Study ID Numbers: |
LIPO-202-CL-31 |
First Posted: | December 29, 2016 Key Record Dates |
Last Update Posted: | October 20, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
submental Salmeterol Xinafoate LIPO-202 bulge |
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 |