NCT07527559Not yet recruiting
Fuzzle System for Appetite Control and Weight Management
A Randomized Controlled Study Evaluating the Safety and Effectiveness of the Fuzzle Intraoral Device for Weight Management
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 78 (estimated)
- First submitted
- 7 Apr 2026
- Start date
- May 2026
- Primary completion date
- Sept 2026
- Lead sponsor
- Fuzzle Operating Co.
- Diseases
- Obesity
- NCT number
- NCT07527559
What you commit to
- Study type: Interventional
- Planned participants: 78
- From May 2026 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of prescription or over-the-counter weight-loss medications
Other illness
- History of eating disorders or uncontrolled psychiatric illness
- Oral or dental conditions preventing safe device use
- Unstable diabetes medication regimen (glycemic subset exclusion only)
- Any medical condition that, in the investigator's judgment, would interfere with safe participation
Other
- Participation in another weight-loss clinical study within 90 days
- Pregnancy, breastfeeding, or intent to become pregnant during the study period
- A1C \>8.0% at screening (glycemic subset exclusion only)
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| DM Clinical Research Coordinator of this site? Confirm its status | Bradenton | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.