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

December 23, 2025 updated by: Melissa Susan Putman, Massachusetts General Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Diabetes Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Melissa S Putman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Smartwatch activity monitor
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.
Device: Smartwatch activity and body composition monitor
Participants will be provided a smartwatch to monitor their exercise and body composition
Behavioral: General guidance on recommended exercise
Participants will receive general guidance on recommended exercise
Active Comparator: Usual guidance
Participants will receive general guidance on recommended exercise
Behavioral: General guidance on recommended exercise
Participants will receive general guidance on recommended exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lean mass (kg)
Time Frame: 6 months
Dual-energy X-ray absorptiometry (DXA) body composition measure
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lean mass index (kg/m2)
Time Frame: 6 months
Dual-energy X-ray absorptiometry (DXA) body composition measure
6 months
Appendicular lean mass index (kg/m2)
Time Frame: 6 months
Dual-energy X-ray absorptiometry (DXA) body composition measure
6 months
Fat mass index (kg/m2)
Time Frame: 6 months
Dual-energy X-ray absorptiometry (DXA) body composition measure
6 months
Fat mass (kg)
Time Frame: 6 months
Dual-energy X-ray absorptiometry (DXA) body composition measure
6 months
Visceral adipose tissue (kg)
Time Frame: 6 months
Dual-energy X-ray absorptiometry (DXA) body composition measure
6 months
Lean mass/fat mass ratio
Time Frame: 6 months
Dual-energy X-ray absorptiometry (DXA) body composition measure
6 months
Fat free mass
Time Frame: 6 months
Bioimpedance analysis body composition measure
6 months
Hand grip strength (kg)
Time Frame: 6 months
Function strength measurement
6 months
1-minute sit-to-stand
Time Frame: 6 months
Number of sit-to-stand repetitions in one minute
6 months
6-minute walk test
Time Frame: 6 months
Distance walked in six minutes
6 months
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
6 months
Physical activity score
Time Frame: 6 months
International Physical Activity Questionnaire (IPAQ)
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lumbar spine bone mineral density (g/cm2)
Time Frame: 6 months
Dual energy Xray absorptiometry
6 months
Total hip bone mineral density (g/cm2)
Time Frame: 6 months
Dual energy Xray absorptiometry
6 months
Femoral neck bone mineral density (g/cm2)
Time Frame: 6 months
Dual energy Xray absorptiometry
6 months
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.
6 months
Patient Health Questionaire-8 (PHQ-8)
Time Frame: 6 months
8-item scale that measures depressive symptoms over the past two weeks
6 months
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.
6 months
Participant feedback survey
Time Frame: 6 months
Survey with questions to understand participant experience with the study
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Samsung

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melissa Putman, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025P001490

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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