Actively Recruiting

Phase 1
Age: 18Years - 89Years
All Genders
Healthy Volunteers
NCT05071898

Pharmacogenetics of Response to GLP1R Agonists

Led by University of Maryland, Baltimore · Updated on 2025-07-01

600

Participants Needed

1

Research Sites

298 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Pharmacogenetics of Response to GLP1R Agonists

Who Can Participate

Age: 18Years - 89Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI greater than or equal to 27 kg/m2
  • Of Amish descent
Not Eligible

You will not qualify if you...

  • 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 increasing risk as judged by research physician or PIs
  • eGFR less than 60 mL/min/1.73 sq. m.
  • Hematocrit less than 35%
  • TSH less than 0.4 or greater than 5.5
  • AST or ALT greater than 2 times the upper limit of normal
  • Unable to discontinue drugs, vitamins, or supplements that might alter semaglutide response
  • Personal or family history of medullary carcinoma of the thyroid or multiple endocrine neoplasia, type 2

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amish Research Clinic

Lancaster, Pennsylvania, United States, 17602

Actively Recruiting

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Research Team

A

Amber L Beitelshees, PharmD

CONTACT

S

Simeon I Taylor, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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