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NCT Number: NCT07226947

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

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.

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Key information

Conditions

Obesity Body Composition Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old at time of signing informed consent
  • 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

  • Able to provide informed consent

Exclusion criteria

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

Treatment and study plan

Smartwatch activity and body composition monitor

Device

Participants will be provided a smartwatch to monitor their exercise and body composition

General guidance on recommended exercise

Behavioral

Participants will receive general guidance on recommended exercise

Primary outcomes

  1. Lean mass (kg)

    Time frame: 6 months

    Dual-energy X-ray absorptiometry (DXA) body composition measure

Secondary outcomes

  1. Lean mass index (kg/m2)

    Time frame: 6 months

    Dual-energy X-ray absorptiometry (DXA) body composition measure

  2. Appendicular lean mass index (kg/m2)

    Time frame: 6 months

    Dual-energy X-ray absorptiometry (DXA) body composition measure

  3. Fat mass index (kg/m2)

    Time frame: 6 months

    Dual-energy X-ray absorptiometry (DXA) body composition measure

  4. Fat mass (kg)

    Time frame: 6 months

    Dual-energy X-ray absorptiometry (DXA) body composition measure

  5. Visceral adipose tissue (kg)

    Time frame: 6 months

    Dual-energy X-ray absorptiometry (DXA) body composition measure

  6. Lean mass/fat mass ratio

    Time frame: 6 months

    Dual-energy X-ray absorptiometry (DXA) body composition measure

  7. Fat free mass

    Time frame: 6 months

    Bioimpedance analysis body composition measure

  8. Hand grip strength (kg)

    Time frame: 6 months

    Function strength measurement

  9. 1-minute sit-to-stand

    Time frame: 6 months

    Number of sit-to-stand repetitions in one minute

  10. 6-minute walk test

    Time frame: 6 months

    Distance walked in six minutes

  11. Short Physical Performance Battery frailty score (total points)

    Time frame: 6 months

    Physical functioning test consisting of standing balance, gait speed, and repeated chair stands

  12. Physical activity score

    Time frame: 6 months

    International Physical Activity Questionnaire (IPAQ)

Other outcomes

  1. Lumbar spine bone mineral density (g/cm2)

    Time frame: 6 months

    Dual energy Xray absorptiometry

  2. Total hip bone mineral density (g/cm2)

    Time frame: 6 months

    Dual energy Xray absorptiometry

  3. Femoral neck bone mineral density (g/cm2)

    Time frame: 6 months

    Dual energy Xray absorptiometry

  4. Dimensional Anhedonia Scale (DARS)

    Time frame: 6 months

    17 item Self-report scale that measures anhedonia, scores measured from 0-68 with higher scores signifying a better outcome.

  5. Patient Health Questionaire-8 (PHQ-8)

    Time frame: 6 months

    8-item scale that measures depressive symptoms over the past two weeks

  6. Generalized Anxiety Disorder 7 item scale (GAD-7)

    Time frame: 6 months

    7-item scale that measures anxiety symptoms over the past few days. Scores measured from 0-21 with higher scores signifying a worse outcome.

  7. Participant feedback survey

    Time frame: 6 months

    Survey with questions to understand participant experience with the study

Study contacts

Contact information is provided by the study sponsor or research team.

Ben O Brenner, BS

CONTACT

[email protected]

617-726-1729

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Samsung

Registry information

Official study title

BIA Monitoring and Exercise for the Prevention of Muscle Loss With Incretin Therapy (BICEP Study)

Acronym: BICEP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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