Clinical Trial Radar

Name: Pharmacogenetics of Response to GLP1R Agonists
Creator: University of Maryland, Baltimore
Published: 2021-10-08
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT05071898 (PORT) for Obesity, Diabetes Type 2 is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Pharmacogenetics of Response to GLP1R Agonists (PORT) Phase 1 600

Recruiting

Clinical Trial NCT05071898 (PORT) is designed to study Basic Science for Obesity, Diabetes Type 2. It is a Phase 1 interventional study that is recruiting, having started on April 11, 2022, with plans to enroll 600 participants. Led by University of Maryland, Baltimore, it is expected to complete by December 31, 2027. The latest data from ClinicalTrials.gov was last updated on July 1, 2025.

Brief Summary

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:

Specific Aim #1. To identify genetic varia...

Detailed Description

Overweight/obese otherwise healthy volunteers will be recruited from the Old Order Amish population in Lancaster County, PA. In order to assess pharmacodynamic responses, research participants will undergo two frequently sampled intravenous glucose tolerance tests (FSIGT). The first FSIGT will be conducted at baseline prior to administration of drug. The second FSIGT will be conducted after six weeks of treatment wit...Show More

Official Title

Pharmacogenetics of Response to GLP1R Agonists

Conditions

ObesityDiabetes Type 2

Publications

Taylor SI, Montasser ME, Yuen AH, Fan H, Yazdi ZS, Whitlatch HB, Mitchell BD, Shuldiner AR, Muniyappa R, Streeten EA, Beitelshees AL. Acute pharmacodynamic responses to exenatide: Drug-induced increases in insulin secretion and glucose effectiveness. Diabetes Obes Metab. 2023 Sep;25(9):2586-25...

Other Study IDs

PORT
HP00097563

NCT ID Number

NCT05071898

Start Date (Actual)

2022-04-11

Last Update Posted

2025-07-01

Completion Date (Estimated)

2027-12-31

Enrollment (Estimated)

600

Study Type

Interventional

PHASE

Phase 1

Status

Recruiting

Keywords

GLP-1 receptor agonist
Insulin secretion
Insulin sensitivity
Pharmacogenomics
Semaglutide

Primary Purpose

Basic Science

Design Allocation

N/A

Interventional Model

Single Group

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ExperimentalOpen 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First phase insulin secretion	Area under the curve for plasma insulin levels measured at times between 0-10 min after administration of intravenous glucose (0.3 g/kg)	Measured both at baseline and after completing 6 weeks of semaglutide therapy
Second phase insulin secretion	Area under the curve for plasma insulin levels measured at times between 10-50 min after administration of intravenous glucose (0.3 g/kg)	Measured both at baseline and after completing 6 weeks of semaglutide therapy
Rate of glucose disappearance	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)	Measured both at baseline and after completing 6 weeks of semaglutide therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	This will be measured as the baseline weight in kg minus the weight after completing 6 weeks of semaglutide therapy.	Assessed after completing 6 weeks of semaglutide therapy

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

Accepts Healthy Volunteers

Yes

BMI greater than or equal to 27 kg/m2
Of Amish Descent

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

University of Maryland, Baltimore

Study Responsible Party

Amber Beitelshees, Principal Investigator, Associate Professor of Medicine, University of Maryland, Baltimore

Study Central Contact

Contact: Amber L Beitelshees, PharmD, (410)706-0118, [email protected]

Contact: Simeon I Taylor, MD, PhD, (410)706-6439, [email protected]

1 Study Locations in 1 Countries

United States

Pennsylvania

Amish Research Clinic, Lancaster, Pennsylvania, 17602, United States

Susan Shaub, RN, Contact, (717)392-4948, [email protected]

Recruiting

Pharmacogenetics of Response to GLP1R Agonists (PORT) Phase 1 600

Inclusion Criteria

Exclusion Criteria