NCT05071898 Pharmacogenetics of Response to GLP1R Agonists
| NCT ID | NCT05071898 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2022-04-11 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 600 participants in total. It began in 2022-04-11 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Amber L Beitelshees, PharmD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT05071898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05071898 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05071898 currently recruiting?
Yes, NCT05071898 is actively recruiting participants. Contact the research team at abeitels@som.umaryland.edu for enrollment information.
Where is the NCT05071898 trial being conducted?
This trial is being conducted at Lancaster, United States.
Who is sponsoring the NCT05071898 clinical trial?
NCT05071898 is sponsored by University of Maryland, Baltimore. The principal investigator is Amber L Beitelshees, PharmD at University of Maryland, Baltimore. The trial plans to enroll 600 participants.
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