Recruiting

Pharmacogenetics of Response to GLP1R Agonists

ClinicalTrials.gov IDNCT05071898

PhasePHASE1

Enrollment600

SponsorUniversity of Maryland, Baltimore

Age18 Years

SexALL

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Conditions studied

Obesity, Diabetes Type 2

About this study

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.

Interventions

Drug: Semaglutide 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.

Primary outcomes

First phase insulin secretion (Measured both at baseline and after completing 6 weeks of semaglutide therapy)
Second phase insulin secretion (Measured both at baseline and after completing 6 weeks of semaglutide therapy)
Rate of glucose disappearance (Measured both at baseline and after completing 6 weeks of semaglutide therapy)

Eligibility information

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

Study locations

Amish Research Clinic, Lancaster, Pennsylvania 17602 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.