← Trials/Trial dossier/NCT06825793

Not yet recruitingPhase NA

Semaglutide's Weight Loss Effects in Obesity

Clinical Assessment of Semaglutide-Induced Weight Reduction in Obese Populations

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

Enrollment

56

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoints

Body weight, absolute change (kg)Gut microbiota

Identifiers

Registered as

NCT IDNCT06825793
Org study ID2025-Semaglutide-obesity

Timeline

Milestones

Study first posted2025-02-13actual
Last update posted2025-02-13actual
Study start2025-02-20estimated
Primary completion2026-12-31estimated
Study completion2027-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Age 18-60 years
BMI ≥ 30 kg/m²
At least one self-reported unsuccessful attempt at lifestyle weight loss

Exclusion criteria

Weight change (self-reported) > 5% in the past 3 months prior to screening
Use of any medication for obesity indication in the past 3 months prior to screening.
Use of antidiabetic medications in the past 3 months, or HbA1c ≥ 6.5%, or a history of Type 1 or Type 2 diabetes.
Use of immunosuppressants, corticosteroids, antidiarrheal drugs, antibiotics, probiotics, lipid-lowering medications, and/or other gastrointestinal motility drugs in the past 3 months prior to screening.
A history of endocrine-related overweight or obesity diagnoses, such as Cushing's syndrome.
Triglycerides ≥ 500 mg/dL (5.65 mmol/L) at screening.
Known clinically significant gastric emptying abnormalities (e.g., severe diabetic gastroparesis or gastric outlet obstruction), gastrointestinal diseases, or surgical history.
Thyroid dysfunction.
History of mental illness.
History or family history of multiple endocrine neoplasia or medullary thyroid cancer, or calcitonin ≥ 6 pg/mL.
Abnormal liver function at screening, defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3*ULN.
Abnormal kidney function at screening, defined as estimated glomerular filtration rate (eGFR) < 60 mL/min/1.75m².
History of cardiovascular disease.
History of malignancy.
Pregnancy or breastfeeding.
Any other physiological, psychological, or other conditions deemed by the investigator as unsuitable for participation in the trial.

Endpoints (5)

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
Other (unclassified)
2
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Body weight

Time frame:Weight changes will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatment

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

BMI

Time frame:BMI will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatment

BMI, change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

The blood concentration of semaglutide

Time frame:concentration of semaglutide will be measured at weeks 24 after treatment

Plasma concentration (steady state)

concentration, descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Gut microbiota

Time frame:Gut microtioba will be measured at the following time points: before treatment, and at weeks 4, 8, 12, 16, 20, 24, and 28 after treatment

descriptive

Secondary/protocol endpoint/low confidence

Blood biochemical indicators

Time frame:Blood biochemical indicators will be measured at the following time points: before treatment, and at weeks 16 and 28 after treatment

descriptive

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.