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

NCT02129608 | Completed Phase 3 Results

• 1 other identifier: 14-002370
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obese

Keywords

overweight; obese; central adiposity; Laser; lorcaserin; low level laser therapy; belviq

Outcome Measures

Primary Outcomes (2)

• Change in Waist Circumference

  The change in waist circumference from baseline to 3 months

  3 months

• Change in Weight

  The change in weight from baseline to 3 months

  3 months

Study Arms (3)

LLLT

ACTIVE COMPARATOR

Low Level Laser Therapy (LLLT) once a week for 12 weeks

Device: LLLT

Lorcaserin

ACTIVE COMPARATOR

locarserin monotherapy - 10 mg, twice daily for 12 weeks

Drug: Lorcaserin

LLLT and Lorcaserin

ACTIVE COMPARATOR

LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks

Device: LLLT; Drug: Lorcaserin

Interventions

LLLT DEVICE

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.

Also known as: Low Level Laser, Erchonia® Zerona™ 2.0 Laser

LLLT; LLLT and Lorcaserin

Lorcaserin DRUG

10 mg pills twice daily for 12 weeks.

Also known as: Belviq

LLLT and Lorcaserin; Lorcaserin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Croghan IT, Ebbert JO, Schroeder DR, Hurt RT, Hagstrom V, Clark MM. A randomized, open-label pilot of the combination of low-level laser therapy and lorcaserin for weight loss. BMC Obes. 2016 Sep 29;3:42. doi: 10.1186/s40608-016-0122-4. eCollection 2016.

  PMID: 27708788 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Overweight; Obesity; Obesity, Abdominal

Interventions

Low-Level Light Therapy; lorcaserin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Ivana Croghan
• Organization: Mayo Clinic

domcro@mayo.edu

507-266-1944

Study Officials

• Ivana T. Croghan, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 25, 2014
• First Posted: May 2, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 22, 2016
• Results First Posted: November 22, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)