GLUCOSE-MGH: Genetic Links Understood Through Challenge With Oral Semaglutide Exposure at MGH

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

The food (mixed meal breakfast) the researchers will be studying is specially prepared to contain a set amount of protein, carbohydrates, and fat.

It had 1 arm (groups): GLUCOSE-MGH Study (other).

The registry classes the interventions as drug and other.

More on the Plan

On day 1 (Visit 1), the research subject will present to the Translational and Clinical Research Center (TCRC) after an overnight fast.

The researchers will obtain informed consent, check vital signs, take anthropometric measurements, and draw fasting blood work through an intravenous catheter.

The subject will then be provided a standard mixed meal to be consumed within 30 minutes.

Additional blood will be drawn at the time of meal completion (0 minutes), as well as 5, 15, 30, 60, 90, and 120 minutes following the meal.

Who Took Part

Enrollment: 125 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: Males or non-pregnant females. Ages 18-65 (inclusive). Able/willing to give consent.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: currently taking medications or intending to take medications that affect glycemic parameters, such as glucocorticoids, growth hormone, or fluoroquinolones; personal history of intestinal malabsorption, bariatric surgery, celiac disease, gallbladder disease, or pancreatitis; personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.

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 2024-03-12 with completion listed for 2027-05-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Insulin response to oral semaglutide treatment (time frame: 15 days).

It also tracked 3 secondary outcomes, for example Fasting glucose response to oral semaglutide treatment, Cumulative glucose response to oral semaglutide treatment and Baseline incretin level.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Semaglutide in 125 people.

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.