Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05340868

Genetics of the Acute Response to Oral Semaglutide

Led by Medical University of Bialystok · Updated on 2025-03-26

1000

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Genetics of the Acute Response to Oral Semaglutide

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided informed consent before any study procedures
  • Aged between 18 and 65 years
  • Body mass index (BMI) over 30 kg/m2, or over 27 kg/m2 if diagnosed with prediabetes according to American Diabetes Association criteria
Not Eligible

You will not qualify if you...

  • Diagnosed with serious chronic diseases 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 within the last five years, chronic obstructive pulmonary disease, or major mental illness
  • Use of medications known to cause significant weight gain or loss
  • History of bariatric or stomach surgery affecting drug absorption
  • History of idiopathic acute pancreatitis
  • Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer
  • Women who are pregnant, breastfeeding, planning pregnancy, or not using highly effective contraception
  • Known or suspected allergy to the study drug

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinical Research Centre, Medical University of Bialystok

Bialystok, Podlaskie Voivodeship, Poland, 15-276

Actively Recruiting

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Research Team

L

Lukasz Szczerbinski, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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