RecruitingPhase 1NCT05071898

Pharmacogenetics of Response to GLP1R Agonists

Sponsor

University of Maryland, Baltimore

Enrollment

600 participants

Start Date

Apr 11, 2022

Study Type

INTERVENTIONAL

Conditions

Obesity Diabetes Type 2

Summary

Overweight/obese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA. Lancaster County, PA. Pharmacodynamic responses to GLP1R agonist will be assessed by conducting frequently sampled intravenous glucose tolerance tests (FSIGT) both before and after semaglutide for six weeks. The proposal proposes two specific aims: 1. Specific Aim #1. To identify genetic variants associated with effects of a GLP1R agonist to enhance glucose-stimulated first phase insulin secretion in the two FSIGTs (before and after administration of drug). 2. Specific Aim #2. To identify genetic variants associated with the effect of a GLP1R agonist to accelerate the rate of glucose disappearance as assessed in the two FSIGTs (before and after administration of drug). Genotyping will be conducted using a high-density array with comprehensive coverage of DNA sequence variants. In addition, the analysis will leverage a global imputation panel generated from 1,025 Amish individuals.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a person's genes affect how well they respond to semaglutide (a GLP-1 medication used for weight management and diabetes prevention) in the Amish community. **You may be eligible if...** - You are of Amish descent - Your BMI is 27 or higher (overweight or obese) - You do not have diabetes **You may NOT be eligible if...** - You are a woman of childbearing age who is sexually active - You have a history of diabetes (high blood sugar or HbA1c > 6.5%) - You are allergic to semaglutide - You have poor kidney function (eGFR below 60) - You have thyroid cancer or a family history of a certain type of thyroid cancer (medullary thyroid carcinoma) - You have abnormal thyroid, liver, or blood count results - You take medications that might interfere with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide Pen Injector [Ozempic]

Participants will receive subcutaneously injected semaglutide (0.25 mg/wk) for 4 weeks followed by semaglutide (0.5 mg/wk) for an additional two weeks.