Genetics of the Acute Response to Oral Semaglutide

Launched by MEDICAL UNIVERSITY OF BIALYSTOK · Apr 16, 2022

Keywords

ClinConnect Summary

This clinical trial, titled "Genetics of the Acute Response to Oral Semaglutide," is studying how our genes may affect how well people respond to a medication called semaglutide, taken by mouth. This medication is intended for individuals with prediabetes or obesity and aims to improve health markers such as blood sugar levels, body weight, and fat in the liver. Over three months, participants will have various tests to measure changes in their body, including blood tests and imaging scans to look at fat in the liver and muscles. Some participants will also provide small samples of fat and muscle tissue to help researchers understand the treatment's effects better.

To be eligible for this study, participants must be between 18 and 65 years old and have a body mass index (BMI) over 30, or over 27 if they also have prediabetes. However, people with certain serious health conditions, like severe heart or liver diseases, or those who have had specific surgeries, cannot participate. During the study, participants will receive regular check-ins and tests to monitor their health and any changes that occur due to the medication. This trial is currently recruiting participants, and it offers a chance to contribute to important research that could help improve treatments for conditions related to obesity and diabetes.

Gender

ALL

Eligibility 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