Obesity & OverweightNCT07527559
Fuzzle System for Appetite Control and Weight Management
A study testing Fuzzle Intraoral Device and Lifestyle Management in people with Obesity & Overweight, run by Fuzzle Operating Co. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Fuzzle Intraoral Device and Lifestyle Management
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Study Evaluating the Safety and Effectiveness of the Fuzzle Intraoral Device for Weight Management
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Obesity & Overweight
- Being tested
- Fuzzle Intraoral Device, Lifestyle Management
- Keywords
- Obesity, Overweight, Weight, Weight Management, Fuzzle, Fuzzle Device
- Medical subject headings
- Obesity, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzzle Intraoral DeviceDevice
Also called Fuzzle, Fuzzle Device
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.
Lifestyle ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group not to receive Fuzzle intraoral device. | Active comparator | 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. Receives: Behavioral: Lifestyle Management |
| Investigational group to receive Fuzzle intraoral device | Experimental | 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. Receives: Device: Fuzzle Intraoral Device; Behavioral: Lifestyle Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From study enrollment to completion at 16 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzzle Operating Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dynamed Clinical Research, Advarra
- Responsible party
- Sponsor
- Investigators
- Jeremy McConnell, MD, Principal investigator, Dynamed Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527559
- Sponsor's protocol ID
- FUZ-CT-001
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Evaluating the Safety and Effectiveness of the Fuzzle Intraoral Device for Weight Management
- ClinicalTrials.gov ID
- NCT07527559
- Acronym / sponsor ID
- FUZ-CT-001
- Conditions
- Obesity & Overweight
- Keywords
- Obesity, Overweight, Weight, Weight Management, Fuzzle, Fuzzle Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Fuzzle Operating Co.Industry (pharma, biotech, devices)
- Collaborators
- Dynamed Clinical Research, Advarra
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group not to receive Fuzzle intraoral device. | Active comparator | Behavioral: Lifestyle ManagementParticipants 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. |
| Investigational group to receive Fuzzle intraoral device | Experimental | Device: Fuzzle Intraoral Device, Behavioral: Lifestyle ManagementParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fuzzle Intraoral DeviceAlso: Fuzzle, Fuzzle DeviceThe 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. | Device | Investigational group to receive Fuzzle intraoral device |
| Lifestyle ManagementParticipants 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. | Behavioural | Control group not to receive Fuzzle intraoral device., Investigational group to receive Fuzzle intraoral device |
Primary outcome
Percent Total Body Weight Loss (%TBWL) at 16 Weeks
Time frame: From study enrollment to completion 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.
7 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: From study enrollment to completion at 16 weeks
Proportion of Participants Achieving ≥5% Total Body Weight Loss
Time frame: Baseline to Week 16
Change in Waist Circumference
Time frame: Baseline to Week 16
Change in Weight-Related Quality of Life (IWQOL-Lite-CT)
Time frame: Baseline to Week 16
Device Tolerability Assessed by Oral Comfort Visual Analog Scale (VAS), Adverse Event Incidence, and Device Adherence Metrics
Time frame: Baseline to Week 16
Exploratory Change in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline to Week 16
Exploratory Change in Alanine Aminotransferase (ALT)
Time frame: Baseline to Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeremy McConnell, MD principal investigator
Dynamed Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fuzzle Intraoral Device and Lifestyle Management in people with Obesity & Overweight, run by Fuzzle Operating Co. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeremy McConnell, MD (941-667-2796, jeremy.mcconnell@dmclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Total Body Weight Loss (%TBWL) at 16 Weeks (time frame: From study enrollment to completion at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.