Pharmacogenetics of Response to GLP1R Agonists (NCT05071898) | Clinical Trial Compass
RecruitingPhase 1
Pharmacogenetics of Response to GLP1R Agonists
United States600 participantsStarted 2022-04-11
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* BMI greater than or equal to 27 kg/m2
* Of Amish Descent
Exclusion Criteria:
* Woman of childbearing age who is sexually active
* History of diabetes (HbA1c \> 6.5% or random glucose \>200 mg/dL)
* Known allergy to semaglutide
* Medical issues, which in the judgment of the research physician or PIs might increase the risk associated with participation in the study
* eGFR \< 60 mL/min/1.73 sq. m.
* Hematocrit \< 35%
* TSH \< 0.4 o4 \> 5.5
* AST or ALT in excess of 2X the upper limit of normal
* Unable to discontinue a drug, vitamin, or nutritional supplement, which in the judgment of the research physician or PIs might alter the response to semaglutide
* Personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia, type 2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
First phase insulin secretion
Timeframe: Measured both at baseline and after completing 6 weeks of semaglutide therapy
2
Second phase insulin secretion
Timeframe: Measured both at baseline and after completing 6 weeks of semaglutide therapy
3
Rate of glucose disappearance
Timeframe: Measured both at baseline and after completing 6 weeks of semaglutide therapy