Fuzzle System for Appetite Control and Weight Management

This study is testing if a device called Fuzzle can help adults with obesity lose weight. The Fuzzle device is a custom-made, removable mouthguard you wear during the day. All participants will receive guidance on diet and behavior to help with weight loss. Some will also use the Fuzzle device. Researchers will compare weight loss over 16 weeks between those using the device and those only getting lifestyle counseling. You might be able to join if you are an adult between 18 and 65 years old with a Body Mass Index (BMI) of 30 or higher. The study aims to enroll 78 people, but its current status is unclear.

Study design: This is a randomized, controlled study comparing participants who use the Fuzzle device plus lifestyle counseling to those who receive lifestyle counseling alone. The study plans to enroll 78 participants.
What's involved: You will need to attend study visits and procedures, track food intake using a mobile app, and participate in weekly check-ins. The study lasts for 16 weeks.
Compensation: Not stated in the trial record.
Follow-up: The primary goal is to measure weight loss at 16 weeks after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Fuzzle System for Appetite Control and Weight Management

Not Yet Recruiting

NAAges 18–65InterventionalTreatment

Fuzzle Operating Co.

~78 participants

Updated 2026-04-17 on ClinicalTrials.gov

What's tested:Fuzzle Intraoral DeviceLifestyle Management

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Percent Total Body Weight Loss (%TBWL) at 16 Weeks

Measured over From study enrollment to completion at 16 weeks

Conditions

Obesity & Overweight

Where it's being run

1 sites across 1 states

Florida1

Study leadership

Jeremy McConnell, MD · PRINCIPAL_INVESTIGATOR · Dynamed Clinical Research

Who to contact

Jeremy McConnell, MD

[email protected]

941-667-2796

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Percent Total Body Weight Loss (%TBWL) at 16 WeeksFrom 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.

Trialytics