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

This study has been completed.
Information provided by (Responsible Party):
Ivana Croghan, Mayo Clinic Identifier:
First received: April 25, 2014
Last updated: September 30, 2016
Last verified: September 2016
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.

Condition Intervention Phase
Device: LLLT
Drug: Lorcaserin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Pilot Comparing a Non-invasive Low Level Laser Therapy (LLLT) With Lorcaserin to Reduce Central Adiposity in Overweight Individuals.

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in Waist Circumference [ Time Frame: 3 months ]
    The change in waist circumference from baseline to 3 months

  • Change in Weight [ Time Frame: 3 months ]
    The change in weight from baseline to 3 months

Enrollment: 44
Study Start Date: June 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LLLT
Low Level Laser Therapy (LLLT) once a week for 12 weeks
Device: LLLT
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.
Other Names:
  • Low Level Laser
  • Erchonia® Zerona™ 2.0 Laser
Active Comparator: Lorcaserin
locarserin monotherapy - 10 mg, twice daily for 12 weeks
Drug: Lorcaserin
10 mg pills twice daily for 12 weeks.
Other Name: Belviq
Active Comparator: LLLT and Lorcaserin
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
Device: LLLT
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.
Other Names:
  • Low Level Laser
  • Erchonia® Zerona™ 2.0 Laser
Drug: Lorcaserin
10 mg pills twice daily for 12 weeks.
Other Name: Belviq

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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;
  Contacts and Locations
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Please refer to this study by its identifier: NCT02129608

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Ivana T. Croghan, PhD Mayo Clinic
  More Information

Additional Information:
Responsible Party: Ivana Croghan, PhD, Mayo Clinic Identifier: NCT02129608     History of Changes
Other Study ID Numbers: 14-002370
Study First Received: April 25, 2014
Results First Received: September 30, 2016
Last Updated: September 30, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Mayo Clinic:
central adiposity
low level laser therapy

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms processed this record on April 28, 2017