NCT07527559

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Fuzzle Operating Co. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Fuzzle Intraoral 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.
BEHAVIORAL	Lifestyle Management	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2026-04-14
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study