NCT05340868Recruiting
Genetics of the Acute Response to Oral Semaglutide
Genetics of the Acute Response to Oral Semaglutide (GAROS)
Source: ClinicalTrials.gov · Last updated 26 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 1 Apr 2022
- Start date
- 1 Sept 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Medical University of Bialystok
- Diseases
- Obesity
- NCT number
- NCT05340868
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 1 Sept 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any medications with clinically-proven significant weight gain or loss effects
Other illness
- 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
- Known or suspected hypersensitivity to the test product
Lab values
- 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
Age
- Women of childbearing age who are not using highly effective methods of contraception
Other
- For women - pregnancy, breastfeeding or planning pregnancy.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Centre, Medical University of Bialystok Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.