Pharmacogenetics of Response to GLP1R Agonists

Part of paid clinical trials in Lancaster, Pennsylvania.

Sponsor
University of Maryland, Baltimore
Study ID
NCT05071898
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Apr 11, 2022
Status verified
Jun 2025
Primary completion
Nov 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Open label administration of semaglutide
    Semaglutide: 0.25 mg, sc, q.week for 4 weeks followed by 0.5 mg, sc, q.week for 2 weeks

Primary Outcome Measure

First phase insulin secretion [ Time Frame: Measured both at baseline and after completing 6 weeks of semaglutide therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Amish Research ClinicLancasterPennsylvania17602
Susan Shaub, RN
[email protected]
(717)392-4948

Find similar trials in Lancaster, PA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Amish Research Clinic· Lancaster, PA

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