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NCT02129608 · ClinicalTrials.gov registry record · Phase 3
Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 44
- Enrollment target
NCT02129608: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT02129608 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02129608, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 44 participants
- Enrollment target
Study 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.
Interventions
- DRUG Lorcaserin
- DEVICE LLLT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02129608
The ClinicalTrials.gov registry entry for NCT02129608 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lorcaserin is the first listed.
NCT02129608 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02129608 about?
NCT02129608 is a clinical study titled "Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management". 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 b...
What is the current status of trial NCT02129608?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 44 participants. The study started on 2014-06. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02129608?
The interventions under investigation include: Lorcaserin (DRUG), LLLT (DEVICE).
Who is sponsoring clinical trial NCT02129608?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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