Pharmacogenomics of GLP1 Receptor Agonists

Stopped early · Phase 1

Conditions studied: Type 2 Diabetes

In brief

Healthy volunteers were recruited from the Old Order Amish population in Lancaster County, Pennsylvania. After providing informed consent, research participants were screened for eligibility. The clinical trial was designed as a randomized crossover study in which participants underwent two frequently sampled intravenous glucose tolerance tests - one after receiving a subcutaneous injection of saline and one after receiving a subcutaneous injection of rapid-acting exenatide (BYETTA). The study sought to determine whether genetic variants are associated with the magnitude of the effect of exenatide. However, because the study fell far short of its recruitment targets, it was under-powered to evaluate genetic association. Thus, the data analysis focused on testing the hypothesis that the order of testing (whether the placebo FSIGT was conducted before the exenatide-stimulated FSIGT or whether the FSIGTs were conducted in the reverse order) does not alter the magnitude impact of exenatide on responses to a frequently sampled iv glucose tolerance test.

Key facts

Study ID

NCT05762744

Run by

University of Maryland, Baltimore

People needed

63

Starts

2016-06-01

Expected to finish

2022-10-31

Last updated by the study team

2025-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Member of the Old Order Amish community in Lancaster County, Pennsylvania
• BMI: 18-40 kg/sq.m.

You may not qualify if…

• Known allergy to exenatide
• History of diabetes, random glucose >200 mg/dL, or HbA1c > 6.5%
• Significant debilitating chronic cardiac, hepatic, pulmonary, or renal disease or other diseases that the investigator judges will make interpretation of the results difficult or increase the risk of participation
• Seizure disorder
• Pregnant by self-report or known pregnancy within 3 months of the start of study
• Currently breast feeding or breast feeding within 3 months of the start of the study
• Estimated glomerular filtration rate <60 mL/min/1.73m2
• Hematocrit <35%
• Liver function tests greater than 2 times the upper limit of normal
• Abnormal thyroid stimulating hormone
• History of pancreatitis or pancreatic cancer. Personal or family history of medullary carcinoma of the thyroid.

Where it is running

• Amish Research Clinic — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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