Pharmacogenetics of Response to GLP1R Agonists

What Was Tested

The trial (phase 1) is built around Semaglutide.

Overweight/obese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA.

The proposal proposes two specific aims: 1.

It had 1 arm (groups): Open label administration of semaglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

The first FSIGT will be conducted at baseline prior to administration of drug.

The proposal proposes two specific aims: * Specific Aim #1.

Women of child-bearing potential will undergo a urine pregnancy test.

An FSIVGTT will be conducted as follows: IV (intravenous) access will be established in both arms of the research participant, one for glucose infusion and the other for frequent blood sampling.

Who Took Part

Enrollment: 600 planned participants were the target.

It was open to people of any sex aged from 18 years up to 89 years.

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

Examples of who could join: BMI greater than or equal to 27 kg/m2. Of Amish Descent.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: woman of childbearing age who is sexually active; known allergy to semaglutide; TSH \< 0.4 o4 \> 5.5.

How the Study Was Run

It was run as a single-group and open-label study.

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 2022-04-11 with completion listed for 2027-04-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): First phase insulin secretion (time frame: Measured both at baseline and after completing 6 weeks of semaglutide therapy). Second phase insulin secretion (time frame: Measured both at baseline and after completing 6 weeks of semaglutide therapy). Rate of glucose disappearance (time frame: Measured both at baseline and after completing 6 weeks of semaglutide therapy).

It also tracked 1 secondary outcome, for example Weight loss.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Semaglutide in 600 people.

With 600 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.