Fuzzle System for Appetite Control and Weight Management

NCT07527559 | Not Yet Recruiting FDA Device

• 1 other identifier: FUZ-CT-001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight

Keywords

Obesity; Overweight; Weight; Weight Management; Fuzzle; Fuzzle Device

Outcome Measures

Primary Outcomes (1)

• 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.

  From study enrollment to completion at 16 weeks

Secondary Outcomes (7)

• Change in Body Mass Index (BMI)

  From study enrollment to completion at 16 weeks

• Proportion of Participants Achieving ≥5% Total Body Weight Loss

  Baseline to Week 16

• Change in Waist Circumference

  Baseline to Week 16

• Change in Weight-Related Quality of Life (IWQOL-Lite-CT)

  Baseline to Week 16

• Device Tolerability Assessed by Oral Comfort Visual Analog Scale (VAS), Adverse Event Incidence, and Device Adherence Metrics

  Baseline to Week 16

Other Outcomes (1)

• Exploratory Change in Glycated Hemoglobin (HbA1c)

  From study enrollment to completion at 16 weeks

Study Arms (2)

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.

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.

Device: Fuzzle Intraoral Device; Behavioral: Lifestyle Management

Interventions

Fuzzle Intraoral Device 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.

Also known as: Fuzzle, Fuzzle Device

Investigational group to receive Fuzzle intraoral device

Lifestyle Management BEHAVIORAL

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.

Control group not to receive Fuzzle intraoral device.; Investigational group to receive Fuzzle intraoral device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any medical condition that, in the investigator's judgment, would interfere with safe participation

Sponsors & Collaborators

• Fuzzle Operating Co.: lead
• Advarra: collaborator
• Dynamed Clinical Research: collaborator

Study Sites (1)

DM Clinical Research

Bradenton, Florida, 34209, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeremy McConnell, MD

  Dynamed Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy McConnell, MD

CONTACT

941-667-2796; jeremy.mcconnell@dmclinical.com

Brandon Essink, MD

CONTACT

941-667-2796; brandon.essink@dmclinical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)