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BICEP

RecruitingPhase NA

Body 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)

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

NCT IDNCT07226947
Org study ID2025P001490

Timeline

Milestones

Study first posted2025-11-12actual
Study start2025-11-24actual
Last update posted2025-12-30actual
Primary completion2027-06estimated (month precision)
Study completion2027-06estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted

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
Other clinical outcomes
6
Patient-reported / QoL
5
Heart failure
1

Weight & body composition

8 endpoints
Primary/protocol endpoint

Lean mass (kg)

Time frame:6 months

Lean mass

descriptive, improvement

Secondary/protocol endpoint

Lean mass index (kg/m2)

Time frame:6 months

Lean mass

descriptive, improvement

Secondary/protocol endpoint

Appendicular lean mass index (kg/m2)

Time frame:6 months

descriptive

Secondary/protocol endpoint

Fat mass index (kg/m2)

Time frame:6 months

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Fat mass (kg)

Time frame:6 months

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Visceral adipose tissue (kg)

Time frame:6 months

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Lean mass/fat mass ratio

Time frame:6 months

ratio, improvement

Secondary/protocol endpoint

Fat free mass

Time frame:6 months

Lean mass

change from baseline, improvement

Heart failure

1 endpoint
Secondary/protocol endpoint

6-minute walk test

Time frame:6 months

6-minute walk distance

change from baseline, improvement

Patient-reported / QoL

5 endpoints
Secondary/protocol endpoint

Physical activity score

Time frame:6 months

change from baseline, improvement

Other/protocol endpoint

Dimensional Anhedonia Scale (DARS)

Time frame:6 months

descriptive, improvement

Other/protocol endpoint

Patient Health Questionaire-8 (PHQ-8)

Time frame:6 months

change from baseline, improvement

Other/protocol endpoint

Generalized Anxiety Disorder 7 item scale (GAD-7)

Time frame:6 months

change from baseline, improvement

Other/protocol endpoint

Participant feedback survey

Time frame:6 months

descriptive

Other clinical outcomes

6 endpoints
Secondary/protocol endpoint

Hand grip strength (kg)

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

1-minute sit-to-stand

Time frame:6 months

descriptive, improvement

Secondary/protocol endpoint

Short Physical Performance Battery frailty score (total points)

Time frame:6 months

change from baseline, improvement

Other/protocol endpoint/low confidence

Lumbar spine bone mineral density (g/cm2)

Time frame:6 months

change from baseline, descriptive

Other/protocol endpoint/low confidence

Total hip bone mineral density (g/cm2)

Time frame:6 months

descriptive

Other/protocol endpoint/low confidence

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.