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Genetics of the Acute Response to Oral Semaglutide

RecruitingNAAges 18 Years - 65 YearsAllMedical University of Bialystok
NCT05340868 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study aims to investigate the genetic basis of the response to short-term (3 months) orally administered semaglutide treatment, in terms of improving metabolic parameters, including the hormonal response to a standardized meal, and changes in body composition and liver steatosis. In the study, parameters such as fasting and 2-hour glucose during OGTT, HbA1c, body fat mass, body weight, total cholesterol, HDL and LDL, triglycerides, HOMA-IR, Matsuda Index and liver steatosis will be assessed. All the patients will undergo genome-wide genotyping. Moreover, in a subset of participants, muscle and fat biopsies will be performed, before and after the treatment, and liver, muscle and pancreas fat content will be assessed using MRI.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Informed consent was given before any study-related action on the subject. * Age: 18-65 years old * Body mass index (BMI) \>30 kg/m2 or \>27 kg/m2 when accompanied by prediabetes, diagnosed according to the criteria of the American Diabetes Association Exclusion Criteria: * Patients diagnosed with a serious chronic disease, including: * Ischemic heart disease * Heart failure (NYHA class III-IV) * Severe renal insufficiency (eGFR \<30 ml/min) * Severe liver diseases * Inflammatory bowel disease * Diabetic gastroparesis * Cancer - currently or in the last five years prior to screening * Chronic obstructive pulmonary disease * History of mental illness, major depression or other severe mental disorders * Use of any medications with clinically-proven significant weight gain or loss effects * History of undergoing bariatric surgery or other surgery involving the stomach that could affect the absorption of the study drug (according to the investigator's opinion) * History of idiopathic acute pancreatitis * A family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer * For women - pregnancy, breastfeeding or planning pregnancy. * Women of childbearing age who are not using highly effective methods of contraception * Known or suspected hypersensitivity to the test product
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What it tests

  • Semaglutide Pill
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Where

1 site
Clinical Research Centre, Medical University of Bialystok
Bialystok, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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