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Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals
Effectiveness of Combined GLP-1/GIP Dual Agonist Therapy and Structured Exercise on Skeletal Muscle Morphology, Quality, and Physical Function in Overweight and Obese Individuals: a Randomized Controlled Trial Protocol
Lead sponsor
Assets
GLP-1 / incretin class catch-all / Tirzepatide
Listed sites
0
Recruiting sites
—
Enrollment
108
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥27
Primary endpoints
•Muscle thickness•Muscle echo intensity
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
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
2 endpointsBody weight
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Body mass index
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Glycemic / diabetes
1 endpointClinical measures (fasting glucose)
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Cardiometabolic biomarkers
2 endpointsClinical parameters (blood pressure)
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Clinical parameters (lipid profile)
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Patient-reported / QoL
1 endpointQuality of life (Short Form-36)
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Other clinical outcomes
1 endpointSelf-reported physical activity
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Other (unclassified)
13 endpointsChange in muscle thickness
Time frame:Baseline, 12 weeks, 24 weeks
change from baseline, improvement
Muscle echo intensity
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Muscle strength (handheld dynamometer)
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Six-minute walk test
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Physical activity
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Nutritional status (3-day food record)
Time frame:Baseline, 12 weeks, 24 weeks
categorical status, descriptive
Height
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Body fat percentage
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Fat free mass
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Chair stand test
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Grip strength
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Muscle thickness
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
Muscle echo intensity
Time frame:Baseline, 12 weeks, 24 weeks
descriptive
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.