An interventional study of Fuzzle Intraoral Device and Lifestyle Management in Obesity & Overweight, sponsored by Fuzzle Operating Co.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Fuzzle Operating Co. · Not applicable, Interventional, and Treatment
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.
The purpose of this study is to evaluate the effectiveness of the Fuzzle intraoral device as an adjunct to standardized lifestyle counseling for weight management in adults with obesity (BMI ≥30 kg/m², ages 18-65).
This randomized, controlled study compares participants receiving the Fuzzle device in combination with standardized lifestyle counseling to those receiving lifestyle counseling alone over a 16-week period.
The primary objective is to assess whether use of the Fuzzle device results in greater percent total body weight loss at 16 weeks compared to standardized lifestyle counseling alone.
All participants receive standardized dietary and behavioral counseling, including caloric targets based on estimated energy expenditure and structured adherence support with regular follow-up. This design is intended to isolate the effect of the device as an adjunctive intervention to a controlled behavioral baseline.
The Fuzzle intraoral device is a custom-fabricated, removable oral appliance designed for daytime wear. It is intended to modulate oral sensory input within the stomatognathic system to influence eating-related behaviors, including reductions in snacking frequency and alterations in meal patterns. The device is non-invasive, reversible, and used in a home setting under provider supervision.
A subset of participants will provide blood samples for exploratory metabolic markers, including HbA1c, hsCRP, and ALT.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 78 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with Fuzzle Operating Co. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standardized lifestyle management including dietary guidance, caloric targets based on estimated energy expenditure, and structured behavioral counseling. Participants track food intake using a mobile application with weekly check-ins to reinforce adherence.
Behavioral: Lifestyle Management
Participants receive the Fuzzle intraoral device in addition to standardized lifestyle management as described in the control arm. Participants are instructed to wear the device during waking hours, excluding meals and oral hygiene.
Device: Fuzzle Intraoral Device · Behavioral: Lifestyle Management
The Fuzzle intraoral device is a custom-fabricated, removable oral appliance designed for daytime wear as an adjunct to weight management. The device is created from dental impressions to ensure a patient-specific fit. Participants are instructed to wear the device during waking hours, excluding meals and oral hygiene. The device is intended to modulate oral sensory input within the stomatognathic system, with the goal of influencing eating-related behaviors, including reductions in snacking frequency and alterations in meal patterns. It is non-invasive, reversible, and used in a home setting under provider supervision.
Also known as: Fuzzle, Fuzzle Device
Participants receive standardized lifestyle management including dietary guidance, caloric targets based on estimated energy expenditure, and structured behavioral counseling. Participants track food intake using a mobile application with weekly check-ins to reinforce adherence.
Percent Total Body Weight Loss (%TBWL) at 16 Weeks
Percent total body weight loss (%TBWL) will be compared between study arms at Week 16. %TBWL is calculated as \[(baseline body weight - Week 16 body weight) ÷ baseline body weight\] × 100, where higher values indicate greater weight loss. Body weight will be measured using standardized procedures during in-person clinic visits.
Time frame: From study enrollment to completion at 16 weeks
Change in Body Mass Index (BMI)
Body mass index (BMI, kg/m²) will be calculated as weight in kilograms divided by height in meters squared and compared between study arms based on change from baseline to Week 16.
Time frame: From study enrollment to completion at 16 weeks
Proportion of Participants Achieving ≥5% Total Body Weight Loss
The proportion of participants achieving at least 5% reduction from baseline body weight at Week 16 will be compared between study arms.
Time frame: Baseline to Week 16
Change in Waist Circumference
Waist circumference (cm) will be measured using standardized methods at clinic visits and compared between study arms based on change from baseline to Week 16.
Time frame: Baseline to Week 16
Change in Weight-Related Quality of Life (IWQOL-Lite-CT)
Weight-related quality of life will be assessed using the IWQOL-Lite-CT instrument, with scores compared between study arms based on change from baseline to Week 16. Higher scores indicate improved quality of life.
Time frame: Baseline to Week 16
Device Tolerability Assessed by Oral Comfort Visual Analog Scale (VAS), Adverse Event Incidence, and Device Adherence Metrics
Fuzzle system tolerability will be evaluated using participant-reported comfort, safety monitoring, and adherence to use. Oral comfort will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no discomfort and 10 indicates extreme discomfort, collected at regular intervals throughout the study period. Adverse events will be recorded and categorized by frequency, severity (mild, moderate, severe), and relationship to the Fuzzle system. Device adherence will be measured using system-recorded and/or participant-reported usage, including average daily wear time and percentage of prescribed use over the study period.
Time frame: Baseline to Week 16
Exploratory Change in High-Sensitivity C-Reactive Protein (hsCRP)
In a predefined subset of participants with baseline HbA1c between 5.7% and 7.5%, change from baseline to Week 16 in high-sensitivity C-reactive protein (hsCRP), measured in milligrams per liter (mg/L), will be evaluated. Analyses will be descriptive.
Time frame: Baseline to Week 16
Exploratory Change in Alanine Aminotransferase (ALT)
In a predefined subset of participants with baseline HbA1c between 5.7% and 7.5%, change from baseline to Week 16 in alanine aminotransferase (ALT), measured in units per liter (U/L), will be evaluated. Analyses will be descriptive.
Time frame: Baseline to Week 16
Exploratory Change in Glycated Hemoglobin (HbA1c)
In a predefined subset of participants with baseline HbA1c between 5.7% and 7.5%, change from baseline to Week 16 in glycated hemoglobin (HbA1c), measured as a percentage (%), will be evaluated. Analyses will be descriptive.
Time frame: From study enrollment to completion at 16 weeks
Start is estimated for May 2026; primary completion for Sep 2026, 4 months later.
Of 163 industry-sponsored interventional studies with no phase under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 4 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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