Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): LLLT; Lorcaserin
Intervention type(s): Device; Drug
Intervention description(s): 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.
Other intervention name(s): Low Level Laser; Erchonia® Zerona™ 2.0 Laser; Belviq
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight; obese; central adiposity; Laser; lorcaserin; low level laser therapy; belviq