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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic

Criteria

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;