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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02129608
Recruitment Status : Completed
First Posted : May 2, 2014
Results First Posted : November 22, 2016
Last Update Posted : November 22, 2016
Information provided by (Responsible Party):
Ivana Croghan, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Overweight Obese Device: LLLT Drug: Lorcaserin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Lorcaserin

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02129608

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Ivana T. Croghan, PhD Mayo Clinic
Additional Information:
Publications of Results:
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Responsible Party: Ivana Croghan, PhD, Mayo Clinic Identifier: NCT02129608    
Other Study ID Numbers: 14-002370
First Posted: May 2, 2014    Key Record Dates
Results First Posted: November 22, 2016
Last Update Posted: November 22, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ivana Croghan, Mayo Clinic:
central adiposity
low level laser therapy
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms