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

NCT07226947 | Recruiting

• 1 other identifier: 2025P001490
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 retatrutide), also known as glucagon-like peptide 1 receptor agonist (GLP-1 RA) medications.

Conditions

Obesity; Body Composition

Outcome Measures

Primary Outcomes (1)

• Lean mass (kg)

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

  6 months

Secondary Outcomes (12)

• Lean mass index (kg/m2)

  6 months

• Appendicular lean mass index (kg/m2)

  6 months

• Fat mass index (kg/m2)

  6 months

• Fat mass (kg)

  6 months

• Visceral adipose tissue (kg)

  6 months

Other Outcomes (7)

• Lumbar spine bone mineral density (g/cm2)

  6 months

• Total hip bone mineral density (g/cm2)

  6 months

• Femoral neck bone mineral density (g/cm2)

  6 months

Study Arms (2)

Smartwatch activity monitor

EXPERIMENTAL

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; Behavioral: General guidance on recommended exercise

Usual guidance

ACTIVE COMPARATOR

Participants will receive general guidance on recommended exercise

Behavioral: General guidance on recommended exercise

Interventions

Smartwatch activity and body composition monitor DEVICE

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

Smartwatch activity monitor

General guidance on recommended exercise BEHAVIORAL

Participants will receive general guidance on recommended exercise

Smartwatch activity monitor; Usual guidance

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Samsung: collaborator

Study Sites (1)

Diabetes Research Center

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 38687506 BACKGROUND

• 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.

  PMID: 16685058 BACKGROUND

• 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.

  PMID: 26949037 BACKGROUND

• 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.

  PMID: 27266673 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 37366315 BACKGROUND

• 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.

  PMID: 37385275 BACKGROUND

• 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.

  PMID: 35658024 BACKGROUND

• 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.

  PMID: 33567185 BACKGROUND

Related Links

• Recruitment website for this study

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Melissa Putman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ben O Brenner, BS

CONTACT

617-726-1729; bbrenner1@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 12, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)