Fuzzle System for Appetite Control and Weight Management

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

Other trials for the same condition