Fuzzle System for Appetite Control and Weight Management (NCT07527559) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fuzzle System for Appetite Control and Weight Management
United States78 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Total Body Weight Loss (%TBWL) at 16 Weeks
Timeframe: From study enrollment to completion at 16 weeks