Recruiting
Phase 1

Semaglutide

Sponsor:

University of Maryland, Baltimore

Code:

NCT05071898

Conditions

Obesity

Diabetes Type 2

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Semaglutide Pen Injector [Ozempic]

Study Details

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:

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

Obesity

Diabetes Type 2

Study ID

NCT05071898

Start date

Apr 11, 2022

Status verified date

Jul, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Amber L Beitelshees, PharmD

(410)706-0118abeitels@som.umaryland.edu

Simeon I Taylor, MD, PhD

(410)706-6439staylor2@som.umaryland.edu

Locations

Amish Research Clinic

Recruiting

Lancaster, Pennsylvania, United States, 17602

Contacts

Susan Shaub, RN

(717)392-4948sshaub@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • GLP-1 receptor agonist
  • Insulin secretion
  • Insulin sensitivity
  • Pharmacogenomics
  • Semaglutide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-27.