Clinical trial

Pharmacogenetics of Response to GLP1R Agonists

Recruiting now · Phase 1 · 1 countries · Registry ID NCT05071898

Recruiting nowPhase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 89 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Diabetes Type 2

Full registry 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

Treatments and study arms

Semaglutide Pen Injector [Ozempic]

Drug

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 secretionMeasured both at baseline and after completing 6 weeks of semaglutide therapy

Area under the curve for plasma insulin levels measured at times between 0-10 min after administration of intravenous glucose (0.3 g/kg)

Second phase insulin secretionMeasured both at baseline and after completing 6 weeks of semaglutide therapy

Area under the curve for plasma insulin levels measured at times between 10-50 min after administration of intravenous glucose (0.3 g/kg)

Rate of glucose disappearanceMeasured both at baseline and after completing 6 weeks of semaglutide therapy

Slope of the plot of log(glucose concentration) as a function of time. This will be calculated based on a linear regression using data points between 25-50 minutes after administration of intravenous glucose (0.3 g/kg)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Amish Research Clinic🇺🇸 Lancaster, Pennsylvania, United States

Open map

Susan Shaub, RNContact

Email · Call (717)392-4948