Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management
Condition: Overweight; Obese
MeSH terms: Overweight
Intervention: LLLT; Lorcaserin
Intervention description: 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.; 10 mg pills twice daily for 12 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: overweight; obese; central adiposity; Laser; lorcaserin; low level laser therapy; belviq

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.
    

Eligibility 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;