Understanding how genetics affect response to GLP1R agonists in obesity and diabetes
Pharmacogenetics of Response to GLP1R Agonists
PHASE1 · University of Maryland, Baltimore · NCT05071898
This study is testing how genetics affect the way overweight or obese people from the Old Order Amish community respond to the diabetes medication semaglutide.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore (other) |
| Locations | 1 site (Lancaster, Pennsylvania) |
| Trial ID | NCT05071898 on ClinicalTrials.gov |
What this trial studies
This study recruits overweight or obese volunteers from the Old Order Amish population in Lancaster County, PA, to investigate the pharmacogenetic responses to the GLP1R agonist semaglutide. Participants will undergo two frequently sampled intravenous glucose tolerance tests (FSIGT) before and after a six-week treatment with semaglutide. The study aims to identify genetic variants that influence insulin secretion and glucose disappearance rates in response to the medication. Genotyping will be performed using a high-density array to comprehensively analyze DNA sequence variants.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese individuals of Amish descent with a BMI of 27 kg/m2 or higher.
Not a fit: Patients with a history of diabetes or those who are pregnant or planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for obesity and type 2 diabetes based on genetic profiles.
How similar studies have performed: While pharmacogenetic approaches have been explored in other contexts, this specific investigation into GLP1R agonists in the Amish population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lancaster, Pennsylvania
- Amish Research Clinic — Lancaster, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Amber L Beitelshees, PharmD — University of Maryland, Baltimore
- Study coordinator: Amber L Beitelshees, PharmD
- Email: abeitels@som.umaryland.edu
- Phone: (410)706-0118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Diabetes Type 2, GLP-1 receptor agonist, Insulin secretion, Insulin sensitivity, Pharmacogenomics, Semaglutide