Fuzzle System for Appetite Control and Weight Management
Starting soon · Not applicable
Conditions studied: Obesity & Overweight
In brief
This study is evaluating whether the Fuzzle intraoral device can help adults with obesity lose weight when used alongside standard lifestyle counseling. Participants in this study will receive guidance on diet and behavior to support weight loss. Some participants will also receive the Fuzzle device, a custom-made removable oral appliance worn during the day. The study will compare weight loss outcomes between participants who use the Fuzzle device and those who follow lifestyle counseling alone over a 16-week period. Researchers will also explore whether use of the device increases the number of participants who achieve meaningful weight loss and may evaluate changes in selected metabolic markers in a subset of participants.
Key facts
- Study ID
- NCT07527559
- Run by
- Fuzzle Operating Co.
- People needed
- 78
- Starts
- 2026-05-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-04-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults aged 18-65 years
- Body mass index (BMI) ≥30 kg/m² at screening
- Willing and able to provide informed consent
- Willing to comply with study visits and procedures
- Willing to participate in standardized lifestyle counseling
You may not qualify if…
- Participation in another weight-loss clinical study within 90 days
- Pregnancy, breastfeeding, or intent to become pregnant during the study period
- History of eating disorders or uncontrolled psychiatric illness
- Oral or dental conditions preventing safe device use
- Current use of prescription or over-the-counter weight-loss medications
- A1C >8.0% at screening (glycemic subset exclusion only)
- Unstable diabetes medication regimen (glycemic subset exclusion only)
- Any medical condition that, in the investigator's judgment, would interfere with safe participation
Where it is running
- DM Clinical Research — Bradenton, Florida, United States
Full record on ClinicalTrials.gov
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