Fuzzle System for Obesity

JM
BE
Overseen ByBrandon Essink, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

JM

Jeremy McConnell, MD

Principal Investigator

Dynamed Clinical Research

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing to comply with study visits and procedures
I am willing to take part in lifestyle counseling sessions.
Body mass index (BMI) ≥30 kg/m² at screening
See 2 more

Exclusion Criteria

Participation in another weight-loss clinical study within 90 days
Oral or dental conditions preventing safe device use
Pregnancy, breastfeeding, or intent to become pregnant during the study period
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Fuzzle intraoral device and/or standardized lifestyle counseling for weight management

16 weeks
Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fuzzle System

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Investigational group to receive Fuzzle intraoral deviceExperimental Treatment2 Interventions
Group II: Control group not to receive Fuzzle intraoral device.Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fuzzle Operating Co.

Lead Sponsor

Dynamed Clinical Research

Collaborator

Advarra

Industry Sponsor

Trials
5
Recruited
680+