Investigating how genetics affect response to oral semaglutide in prediabetes and obesity
Genetics of the Acute Response to Oral Semaglutide (GAROS)
This study is testing how genetics affect how well people with prediabetes and obesity respond to a three-month treatment with oral semaglutide.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of Bialystok Academic / other |
| Locations | 1 site (Bialystok, Podlaskie Voivodeship) |
| Trial ID | NCT05340868 on ClinicalTrials.gov |
What this trial studies
This study explores the genetic factors influencing the response to a three-month treatment with oral semaglutide in individuals with prediabetes and obesity. Participants will undergo various assessments, including blood tests, glucose tolerance tests, and body composition analysis, to evaluate metabolic changes and hormonal responses. Additionally, genome-wide genotyping will be performed, and a subset of participants will have muscle and fat biopsies, along with MRI assessments of fat content in the liver, muscle, and pancreas. The goal is to understand how genetic variations impact treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a BMI over 30 or over 27 with prediabetes.
Not a fit: Patients with serious chronic diseases or those who have undergone bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for prediabetes and obesity based on genetic profiles.
How similar studies have performed: While pharmacogenetic studies are common, this specific approach to semaglutide response in prediabetes is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bialystok, Podlaskie Voivodeship
- Clinical Research Centre, Medical University of Bialystok — Bialystok, Podlaskie Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Lukasz Szczerbinski, MD, PhD — Clinical Research Centre, Medical University of Bialystok
- Study coordinator: Lukasz Szczerbinski, MD, PhD
- Email: lukasz.szczerbinski@umb.edu.pl
- Phone: +48858318150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.