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Clinical Trials in Poland / NCT05340868
Recruiting Not applicable

Genetics of the Acute Response to Oral Semaglutide

NCT05340868 · tracked via the Priya Life Science Poland tracker
Sponsor
Medical University of Bialystok
Phase
Not applicable
Started
2022-09-01
Last updated
2025-03-26

Condition(s) studied

PreDiabetesPrediabetic StateObesity

Investigational drug(s) / intervention(s)

Semaglutide Pill →

Semaglutide Pill: Oral semaglutide treatment

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Glycemic measures - change in HbA1c (%) — 1 and 3 months
    Investigators will measure the change in HbA1c concentration between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.
  • Body composition - change in body weight (kg) — 1 and 3 months
    Investigators will measure the change in body weight measures between Visit 2, Visit 3 and Visit 4 as an index of Semaglutide response, and compare them by genotype at selected loci.

Trial sites (1)

FacilityCityRegionStatus
Clinical Research Centre, Medical University of Bialystok Bialystok Podlaskie Voivodeship Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05340868 on ClinicalTrials.gov ↗ ← All trials in Poland