Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management

Study Overview
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Brief Summary
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Currently in the United States about 97 million adults are considered obese, accounting for about 33% of the American adult population (compared to 22.9% in 1988). Obesity, defined as a body mass index of 30.0 or higher, is accountable for 44% of the diabetes, 23% of the ischemic heart disease and between 7% and 41% of certain cancers. The Erchonia® Zerona™ 2.0 Laser (which will be used in this study) has been approved by the FDA (K123237) as a non-invasive dermatological aesthetic treatment which can be used by individuals intending to reduce circumference of hips, waist, and thighs. Lorcaserin is a selective serotonin 2C (5-HT(2C)) receptor agonist. The exact mechanism of action is not known, but lorcaserin is believed to promote satiety and decrease food intake by activating 5-HT(2C) receptors on anorexigenic pro-opiomelanocortin neurons in the hypothalamus. Lorcaserin was approved by the FDA on June 2012 for weight management in people with a BMI of > 27 kg/m2 (overweight) when accompanied by a weigh-related condition such as type 2 diabetes or high blood pressure or in people with a BMI > 30 kg/m2 (obese). The purpose of this pilot study is to obtain preliminary data on: 1) effectiveness of the combination of LLLT and lorcaserin for reducing abdominal subcutaneous fat in overweight/obese individuals; 2) impact of LLLT on inflammatory biomarkers, blood sugar, and cholesterol.

Detailed Description
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This study is being done to find out how effective Low Level Laser Therapy (LLLT - Erchonia® Zerona™ 2.0 Laser) is compared to Lorcaserin (Belviq®) in helping overweight people reduce their weight gain - especially in the central body region. Subjects will undergo 2 screening visits in which the investigators will take their medical and weight concern histories; and if found eligible, they will be randomized to one of three groups: 1) 12 weeks of LLLT, 2) 12 weeks of Lorcaserin, and 3) 12 weeks of a combination of both Lorcaserin and LLLT. Full study participation will last approximately 6 months and consists of 10 visits- 9 clinical and 1 phone call. During this study subjects will be provided with weight prevention counseling and be asked to complete 3 additional fasting blood draws. There will be one urine pregnancy test (for females only) at the beginning of the study.

Official Title
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A Feasibility Pilot Comparing a Non-invasive Low Level Laser Therapy (LLLT) With Lorcaserin to Reduce Central Adiposity in Overweight Individuals.

Conditions
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Overweight, Obese

Intervention / Treatment
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* Device: LLLT
* Drug: Lorcaserin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be 18-70 years of age; have a body weight of greater than 50 kg (110 pounds); have a BMI 27-39.9 kg/m2; be weight concerned; be motivated to reduce their central adiposity; be able to participate fully in all aspects of the study; have understood and signed study informed consent. Exclusion Criteria: have used weight loss medications or participated in a weight loss program within the past 30 days; are currently taking supplements known to affect weight, such as garcinia cambrogia. have had weight fluctuations of 20 pounds or more in the past 6 months (self-report); have an implanted device (including pacemaker or lap band) in the targeted area of LLLT; have an active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression); have used an investigational drug within 30 days of study enrollment; have a recent history (past 30 days) of alcohol or drug abuse or dependence; are currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception; have a history of any major cardiovascular events including heart valve disease, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease; have current uncontrolled hypertension (systolic > 165 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions; have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as diabetes) or active cancer or are within 1 year of cancer remission; Prior surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc.; medical, physical, or other contraindications for body sculpting/weight loss; current use of medication(s) known to affect weight levels/cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent; concurrently taking a serotonergic drug (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), triptans, bupropion, dextromethorphan, St. John's Wort). These drugs can be used to treat depression and/or migraines but are contraindicated with lorcaserin; any medical condition known to affect weight levels and/or to cause bloating or swelling; diagnosis of, and/or taking medication for, irritable bowel syndrome; active infection, wound or other external trauma to the areas to be treated with the laser; known photosensitivity disorder; are allergic to lorcaserin; current active cancer or currently receiving treatment for cancer; or have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LLLT<br>Low Level Laser Therapy (LLLT) once a week for 12 weeks | Device: LLLT<br>* The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.<br>* Other names: Erchonia® Zerona™ 2.0 Laser;|
| Active Comparator: Lorcaserin<br>locarserin monotherapy - 10 mg, twice daily for 12 weeks | Drug: Lorcaserin<br>* 10 mg pills twice daily for 12 weeks.<br>* Other names: Belviq;|
| Active Comparator: LLLT and Lorcaserin<br>LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks | Device: LLLT<br>* The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.<br>* Other names: Erchonia® Zerona™ 2.0 Laser;Drug: Lorcaserin<br>* 10 mg pills twice daily for 12 weeks.<br>* Other names: Belviq;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Waist Circumference | The change in waist circumference from baseline to 3 months | 3 months | 
| Change in Weight | The change in weight from baseline to 3 months | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obese, central adiposity, Laser, lorcaserin, low level laser therapy, belviq