GLP-1 Peptide Atlas, by Delfa

Active not recruiting

Semaglutide Effectiveness in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease in the Real World Practice

Real-World Clinical Practice Study on the Effectiveness of Semaglutide Over 154 Weeks in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease

Lead sponsor

Center of target therapy

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

MASH / NAFLD / liver fibrosis, Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoints

•Evaluate the impact of semaglutide therapy on liver morphological changes•Evaluate the impact of semaglutide therapy on the degree of steatosis change•Liver fat content, change

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 IDNCT06983171

Org study IDCTT-003

Timeline

Milestones

Study start2025-04-02actual

Study first posted2025-05-21actual

Last update posted2025-12-22actual

Primary completion2028-09-12estimated

Study completion2028-09-12estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

MASH / NAFLD / liver fibrosisObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

This study will enroll adults aged 18-70 years with obesity (BMI \>30 kg/m²) and hepatic steatosis (CAP \>238 dB/m) confirmed within 3 months. Eligible participants must have metabolic dysfunction-associated fatty liver disease (MAFLD) without other chronic liver conditions (e.g., viral hepatitis, cirrhosis complications like ascites, or MELD score \>12).

Inclusion criteria

•Informed consent obtained before performing any research-related action. Research-related procedures include any procedures conducted within the framework of this study, including activities to assess eligibility criteria for participation in the study.

•Body Mass Index (BMI) > 30 kg/m².

•CAP test result > 238 dB/m based on steatometry performed no later than 3 months before the patient is included in the study.

•Age 18-70 years at the time of signing the informed consent.

Exclusion criteria

•Any contraindication to the appointment of semaglutide.

•Documented reasons for chronic liver disease other than non-alcoholic fatty liver disease (NAFLD).

•Positive test result for HBsAg, HIV antibodies, or positive test result for HCV-RNA.

•Presence of ascites, bleeding from esophageal varices, hepatic encephalopathy, spontaneous bacterial peritonitis, or liver transplantation at the time of screening or a history of these conditions.

•ALT activity > 5 times the upper limit of normal (ULN).

•AST activity > 5 times the ULN.

•Alkaline phosphatase activity > 2 times the ULN at screening.

•International Normalized Ratio (INR) of prothrombin time ≥ 1.35 at screening.

•MELD score > 12 points at screening.

•Platelet count less than 150,000 per microliter of blood, unless it reflects the patient's usual platelet level, and the patient does not have a diagnosis of portal hypertension in the investigator's opinion.

•Treatment with GLP-1 receptor agonists within 90 days prior to the screening visit.

•Treatment with hypolipidemic drugs or weight loss medications, whose dosage has not been stable, in the investigator's opinion, for 90 days prior to the screening visit.

•Previous or planned (during the study period) treatment of obesity with surgical intervention or the installation of a special device for weight loss. However, the following procedures are allowed:

1. Liposuction and/or abdominoplasty, if performed more than 1 year before screening.

2. Laparoscopic gastric banding, if the band was removed more than 1 year before baseline liver biopsy and screening.

3. Intragastric balloon placement, if the balloon was removed more than 1 year before baseline liver biopsy and screening.

4. Duodenojejunal sleeve bypass, if the sleeve was removed more than 1 year before baseline liver biopsy and screening.

•Presence of malignant neoplasms currently or in history within the last 5 years prior to screening. Exceptions include only basal cell or squamous cell skin cancer and any carcinoma in situ.

•History of acute pancreatitis within 180 days prior to inclusion in the study.

•Presence of chronic pancreatitis currently or in history.

•Any of the following: myocardial infarction, stroke, heart failure of NYHA class IV, hospitalization for unstable angina, or transient ischemic attack within the last 90 days before the screening day.

•Any health disorder that, in the investigator's opinion, could jeopardize patient safety or affect compliance with the protocol requirements.

Endpoints (9)

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

MASH / liver

Cardiometabolic biomarkers

Cardiovascular outcomes

Weight & body composition

Cardiovascular outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

Evaluate the time to the first cardiovascular event during semaglutide therapy

Time frame:154 weeks

Expanded / custom MACE composite

time to event, event

componentsExpanded / custom MACE composite

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Evaluate the impact of semaglutide therapy on patients' body weight

Time frame:154 weeks

Body weight, % change

percent change from baseline, improvement

MASH / liver

5 endpoints

Primary/protocol endpoint

Evaluate the impact of semaglutide therapy on liver morphological changes based on liver histology using the NAFLD Activity Score (NAS).

Time frame:154 weeks