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BICEP
RecruitingPhase NABody Composition and Exercise to Prevent Muscle Loss With GLP1 Agonist Treatment
BIA Monitoring and Exercise for the Prevention of Muscle Loss With Incretin Therapy (BICEP Study)
Lead sponsor
Asset
GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
1
Enrollment
100
estimated
Study population
Obesity / overweight
Key I/E criterion
—
Primary endpoint
•Lean mass
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (20)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
8 endpointsLean mass (kg)
Time frame:6 months
Lean mass
descriptive, improvement
Lean mass index (kg/m2)
Time frame:6 months
Lean mass
descriptive, improvement
Appendicular lean mass index (kg/m2)
Time frame:6 months
descriptive
Fat mass index (kg/m2)
Time frame:6 months
Total fat mass
change from baseline, improvement
Fat mass (kg)
Time frame:6 months
Total fat mass
change from baseline, improvement
Visceral adipose tissue (kg)
Time frame:6 months
Visceral fat, change
change from baseline, improvement
Lean mass/fat mass ratio
Time frame:6 months
ratio, improvement
Fat free mass
Time frame:6 months
Lean mass
change from baseline, improvement
Heart failure
1 endpoint6-minute walk test
Time frame:6 months
6-minute walk distance
change from baseline, improvement
Patient-reported / QoL
5 endpointsPhysical activity score
Time frame:6 months
change from baseline, improvement
Dimensional Anhedonia Scale (DARS)
Time frame:6 months
descriptive, improvement
Patient Health Questionaire-8 (PHQ-8)
Time frame:6 months
change from baseline, improvement
Generalized Anxiety Disorder 7 item scale (GAD-7)
Time frame:6 months
change from baseline, improvement
Participant feedback survey
Time frame:6 months
descriptive
Other clinical outcomes
6 endpointsHand grip strength (kg)
Time frame:6 months
change from baseline, improvement
1-minute sit-to-stand
Time frame:6 months
descriptive, improvement
Short Physical Performance Battery frailty score (total points)
Time frame:6 months
change from baseline, improvement
Lumbar spine bone mineral density (g/cm2)
Time frame:6 months
change from baseline, descriptive
Total hip bone mineral density (g/cm2)
Time frame:6 months
descriptive
Femoral neck bone mineral density (g/cm2)
Time frame:6 months
descriptive
Publications (8)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Lancet (London, England)2023 Aug 19PMID37385275doi:10.1016/S0140-6736(23)01200-Xvia CT.gov background
- The New England journal of medicine2023 Aug 10PMID37366315doi:10.1056/NEJMoa2301972via CT.gov background
- The New England journal of medicine2022 Jul 21PMID35658024doi:10.1056/NEJMoa2206038via CT.gov background
- The New England journal of medicine2021 Mar 18PMID33567185doi:10.1056/NEJMoa2032183via CT.gov background
- The American journal of cardiology2016 Apr 15PMID26949037doi:10.1016/j.amjcard.2016.01.033via CT.gov background
- Archives of gerontology and geriatrics2016 Sep-Oct (year)PMID27266673doi:10.1016/j.archger.2016.04.017via CT.gov background
- The American journal of clinical nutrition2006 May (month)PMID16685058doi:10.1093/ajcn/83.5.1142via CT.gov background
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.