Clinical Trials

Inclusion Criteria: 

• 18 years of age or older.
• BMI of 25–39.9 kg/m^2.
• Able to participate fully in all aspects of the study.
• Understood and signed study informed consent.

Exclusion Criteria: 

• Used weight loss medications or participated in a weight loss program within the past 30 days.
• Currently taking medications or supplements known to affect weight, such as prednisone or garcinia cambrogia.
• Weight fluctuations of 5 pounds or more in the past month.
• Have an implanted device (including pacemaker or lap band) in the targeted area of LLLT.
• Have a known active eating disorder.
• Have a known, active, untreated clinically significant psychiatric condition (alcohol or substance abuse, psychosis, bipolar disorder, or depression).
• Have used an investigational drug within 30 days of study enrollment.
• Reports being currently pregnant, lactating, or are of child-bearing potential or are likely to become pregnant during the LLLT treatment phase and are unwilling to use a reliable form of contraception.  Acceptable forms include:
  • Hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants;
  • Barrier methods (such as a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm);
  • Intrauterine device (IUD);
  • Total hysterectomy or tubal ligation;
  • Abstinence (no sex).
• Htory of any major cardiovascular events including heart valve disease, ongoing angina, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease.
• Current uncontrolled hypertension (systolic > 160 mm Hg or diastolic > 95 mm Hg) documented on 2 separate occasions.
• 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.
• Surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc. within 12 months prior to enrollment.
• Medical, physical, or other contraindications for body sculpting/weight loss.
• 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.
• Current active cancer or currently receiving treatment for cancer.
• Have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.

Eligibility last updated 12/14/21. Questions regarding updates should be directed to the study team contact.