Body Composition and Exercise to Prevent Muscle Loss With GLP1 Agonist Treatment (BICEP)

Mass General Brigham

Status: Enrolling

Conditions: Obesity; Body Composition

Treatments: Device: Smartwatch activity and body composition monitor; Behavioral: General guidance on recommended exercise

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07226947

2025P001490

Details and patient eligibility

About

The goal of this study is to learn if a smartwatch that measures activity level and body composition, combined with exercise reminders, can safely improve strength and muscle mass in people who recently started or are planning to start treatment with incretin therapy (liraglutide, semaglutide, tirzepatide or retatrutide), also known as glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age ≥ 18 years old at time of signing informed consent

2. Started treatment with incretin therapy (liraglutide, semaglutide, tirzepatide, or retatrutide) within the past 2 months or planning to start this treatment

   a. Potential participants switching GLP1-RA therapies due to inadequate response to a prior treatment will be eligible for enrollment

3. Able to provide informed consent

Exclusion Criteria

1. Current pregnancy (positive urine hCG) or plans to become pregnant in the next 6 months
2. BMI <25 kg/m2 at the time of screening
3. Unable to participate in a regular physical exercise program
4. Implanted pacemaker
5. Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Smartwatch activity monitor

Experimental group

Description:

Participants will be provided a smartwatch to monitor activity and body composition monitor. They will also have exercise goals set with reminders on the watch.

Treatment:

Behavioral: General guidance on recommended exercise

Device: Smartwatch activity and body composition monitor

Usual guidance

Active Comparator group

Description:

Participants will receive general guidance on recommended exercise

Treatment:

Behavioral: General guidance on recommended exercise