Genetics of the Acute Response to Oral Semaglutide

What Was Tested

This registered not phased trial tested Semaglutide.

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.

It had 1 arm (groups): Semaglutide (oral) (experimental).

The registry classes the interventions as drug.

More on the Plan

Each patient will also undergo a detailed body composition analysis using bioimpedance and DXA.

In addition, during the visit, each participant will receive a continuous glucose monitoring system (CGM) and an accelerometer to measure physical activity for a period of 10-14 days.

Visit v3 - four weeks after starting the semaglutide treatment.

During the visit, fasting venous blood will be collected to measure basic metabolic parameters.

Who Took Part

The registry lists 1000 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 3 inclusion and 17 exclusion criteria; among the exclusions: patients diagnosed with a serious chronic disease, including:; ischemic heart disease; heart failure (nyha class iii-iv).

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Semaglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-09-01 with completion listed for 2025-12-31.

It ran at 1 site in Poland.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Glycemic measures - change in HbA1c (%) (time frame: 1 and 3 months). Body composition - change in body weight (kg) (time frame: 1 and 3 months).

It also tracked 4 secondary outcomes, for example Glycemic measures - change in 2-hour glucose (in mg/dl), Glycemic measures - change in fasting glucose (in mg/dl), Body composition - change in body fat content (kg) and Body composition - change in lean body mass content (kg).

What This Means in Plain Language

Put simply, this is a not phased trial of Semaglutide in 1000 people.

With 1000 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.