Enrolling by invitation

Changes in Body Composition Following Pharmacological Treatment for Obesity.

Assessment of Body Composition and Prevalence of Sarcopenia Following Intentional Weight Loss With Medications (Semaglutide or Tirzepatide) in People With Obesity

Lead sponsor

Hospital San Carlos, Madrid

Assets

Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Estimated enrollment

116

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoints

•Sarcopenia•Percentage of total weight loss (TWL)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07908940

Org study ID24/830-O_M_SP

Timeline

Milestones

Study start2025-09-01actual

Primary completion2026-09-30actual

Study first posted2026-11-02actual

Last update posted2026-11-02actual

Study completion2027-12-31estimated

Assets

Investigational agents

Semaglutide Tirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Participants who meet the inclusion criteria will be recruited from Endocrinology and Nutrition clinics at various hospitals and centers specializing in obesity in Spain.

Inclusion criteria

•Subjects of both sexes, aged 18-80 years, with BMI ≥ 30 kg/m2, who are starting pharmacological treatment for the first time (or who have been without treatment with GLP1 analogues for at least 6 months).

•Individuals with a BMI ≥ 30 kg/m² and weight regain of ≥ 15% following the nadir weight achieved after bariatric-metabolic surgery.

•Pharmacological treatment: patients with the capacity to undertake a long-term (minimum 6 months), self-funded treatment regimen with semaglutide or tirzepatide.

•Signing of an informed consent form.

Exclusion criteria

•Type 1 diabetes

•Type 2 diabetes

•Pregnancy and breastfeeding

•Inability to follow an exercise regimen (e.g., due to disabling arthropathy, advanced COPD, skeletal or muscular impairments, or the aftereffects of a stroke, etc.) that prevents effective physical exercise (whether aerobic and/or strength-based).

•Presence of disabling cardiovascular disease (unstable coronary artery disease, NYHA Class IV heart failure).

•Advanced renal impairment (eGFR < 15 ml/min).

•Advanced liver disease (Child-Pugh class B or higher).

•Major psychiatric illness (depression, eating disorders, psychosis, obsessive-compulsive disorder, personality disorders, etc.).

•Individuals who do not reach the maximum tolerable dose of treatment (defined as the highest dose that does not cause side effects), provided that the dose is at least 1 mg of semaglutide or 5 mg of tirzepatide per week.

•Individuals who use the medication intermittently.

•Individuals who switch between different anti-obesity medications during the observation period.

•Allergy to any of the components of the selected medication.

•History of acute pancreatitis or gastroparesis.

•History of MEN-2A (Multiple Endocrine Neoplasia type 2A) or medullary thyroid carcinoma.

Endpoints (2)

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

Other (unclassified)

Weight & body composition

1 endpoint

Primary/protocol endpoint

Percentage of total weight loss (TWL)

Time frame:From enrollment to the end of treatment at 6 and 12 months

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Sarcopenia

Time frame:From enrollment to the end of treatment at 6 and 12 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.