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ObesityBICEPNCT07226947

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

A study testing Smartwatch activity and body composition monitor and General guidance on recommended exercise in people with Obesity and Body Composition, run by Massachusetts General Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Obesity, Body Composition
What is being tested?
Smartwatch activity and body composition monitor and General guidance on recommended exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
24 Nov 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • Potential participants switching GLP1-RA therapies due to inadequate response to a prior treatment will be eligible for enrollment
  • Able to provide informed consent

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ben O Brenner, BS contact

617-726-1729

bbrenner1@mgb.org

United States1 site, 1 recruiting

  • Diabetes Research Center

    Boston, Massachusetts, 02114

    Ben O Brenner, BS, 617-726-1729, bbrenner1@mgb.org

    Grace Kuropatkin, BS, 617-726-6537, gkuropatkin@mgh.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Smartwatch activity and body composition monitor, General guidance on recommended exercise
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartwatch activity and body composition monitorDevice

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

  • General guidance on recommended exerciseBehavioural

    Participants will receive general guidance on recommended exercise

Study groups in NCT07226947
Study groupRoleWhat they receive
Smartwatch activity monitorExperimentalParticipants will be provided a smartwatch to monitor activity and body composition monitor. They will also have exercise goals set with reminders on the watch.
Receives: Device: Smartwatch activity and body composition monitor; Behavioral: General guidance on recommended exercise
Usual guidanceActive comparatorParticipants will receive general guidance on recommended exercise
Receives: Behavioral: General guidance on recommended exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lean mass (kg)

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

    Measured: 6 months

Secondary outcomes (12)

  1. Lean mass index (kg/m2)

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

    Measured: 6 months

  2. Appendicular lean mass index (kg/m2)

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

    Measured: 6 months

  3. Fat mass index (kg/m2)

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

    Measured: 6 months

  4. Fat mass (kg)

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

    Measured: 6 months

  5. Visceral adipose tissue (kg)

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

    Measured: 6 months

  6. Lean mass/fat mass ratio

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

    Measured: 6 months

  7. Fat free mass

    Bioimpedance analysis body composition measure

    Measured: 6 months

  8. Hand grip strength (kg)

    Function strength measurement

    Measured: 6 months

  9. 1-minute sit-to-stand

    Number of sit-to-stand repetitions in one minute

    Measured: 6 months

  10. 6-minute walk test

    Distance walked in six minutes

    Measured: 6 months

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

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

    Measured: 6 months

  12. Physical activity score

    International Physical Activity Questionnaire (IPAQ)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2025
  2. Study start24 Nov 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07226947
Sponsor's protocol ID
2025P001490
Acronym
BICEP
Status last verified
Dec 2025
First submitted
6 Nov 2025
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be available to other researchers.

Publications

  • Locatelli JC, Costa JG, Haynes A, Naylor LH, Fegan PG, Yeap BB, Green DJ. Incretin-Based Weight Loss Pharmacotherapy: Can Resistance Exercise Optimize Changes in Body Composition? Diabetes Care. 2024 Oct 1;47(10):1718-1730. doi: 10.2337/dci23-0100.

    PubMed 38687506

  • Cesari M, Leeuwenburgh C, Lauretani F, Onder G, Bandinelli S, Maraldi C, Guralnik JM, Pahor M, Ferrucci L. Frailty syndrome and skeletal muscle: results from the Invecchiare in Chianti study. Am J Clin Nutr. 2006 May;83(5):1142-8. doi: 10.1093/ajcn/83.5.1142.

    PubMed 16685058

  • Srikanthan P, Horwich TB, Tseng CH. Relation of Muscle Mass and Fat Mass to Cardiovascular Disease Mortality. Am J Cardiol. 2016 Apr 15;117(8):1355-60. doi: 10.1016/j.amjcard.2016.01.033. Epub 2016 Feb 2.

    PubMed 26949037

  • Tyrovolas S, Haro JM, Mariolis A, Piscopo S, Valacchi G, Bountziouka V, Anastasiou F, Zeimbekis A, Tyrovola D, Foscolou A, Gotsis E, Metallinos G, Tur JA, Matalas A, Lionis C, Polychronopoulos E, Panagiotakos D. Skeletal muscle mass and body fat in relation to successful ageing of older adults: The multi-national MEDIS study. Arch Gerontol Geriatr. 2016 Sep-Oct;66:95-101. doi: 10.1016/j.archger.2016.04.017. Epub 2016 May 9.

    PubMed 27266673

  • Tempia Valenta S, Nicastri A, Marcolini F, Petroni ML, Perazza F, Beghelli V, et al. The Impact of GLP-1 Receptor Agonists (GLP-1 RAs) on Mental Health: A Systematic Review. Current Treatment Options in Psychiatry. 2024 Sep 18;11(4):310-57.

  • Jastreboff AM, Kaplan LM, Frias JP, Wu Q, Du Y, Gurbuz S, Coskun T, Haupt A, Milicevic Z, Hartman ML; Retatrutide Phase 2 Obesity Trial Investigators. Triple-Hormone-Receptor Agonist Retatrutide for Obesity - A Phase 2 Trial. N Engl J Med. 2023 Aug 10;389(6):514-526. doi: 10.1056/NEJMoa2301972. Epub 2023 Jun 26.

    PubMed 37366315

  • Garvey WT, Frias JP, Jastreboff AM, le Roux CW, Sattar N, Aizenberg D, Mao H, Zhang S, Ahmad NN, Bunck MC, Benabbad I, Zhang XM; SURMOUNT-2 investigators. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023 Aug 19;402(10402):613-626. doi: 10.1016/S0140-6736(23)01200-X. Epub 2023 Jun 26.

    PubMed 37385275

  • Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4.

    PubMed 35658024

  • Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF; STEP 1 Study Group. Once-Weekly Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2021 Mar 18;384(11):989-1002. doi: 10.1056/NEJMoa2032183. Epub 2021 Feb 10.

    PubMed 33567185

Questions about this trial

What is this clinical trial studying?

A study testing Smartwatch activity and body composition monitor and General guidance on recommended exercise in people with Obesity and Body Composition, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ben O Brenner, BS (617-726-1729, bbrenner1@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lean mass (kg) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07226947, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

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