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GLP1R Agonist

Semaglutide for Type 2 Diabetes (PORT Trial)

Phase 1
Recruiting
Led By Amber L Beitelshees, PharmD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed after completing 6 weeks of semaglutide therapy
Awards & highlights
No Placebo-Only Group

PORT Trial Summary

This trial is looking for genetic variants associated with the effects of a GLP1R agonist on insulin secretion and glucose metabolism in overweight/obese, otherwise healthy Amish volunteers.

Who is the study for?
This trial is for overweight or obese individuals of Amish descent with a BMI of 27 kg/m2 or higher. It's not open to women who can have children and are sexually active, people with certain blood, liver, thyroid conditions, kidney issues (eGFR < 60 mL/min/1.73 sq. m.), a personal or family history of specific cancers, known allergy to semaglutide, or those on medications that could affect the study.Check my eligibility
What is being tested?
The trial tests how Semaglutide affects insulin secretion and glucose disappearance in the body by comparing before and after use in participants. It involves genetic testing to find any variants linked to these effects using frequent blood sugar tests over six weeks.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of Semaglutide may include nausea, vomiting, diarrhea, abdominal pain and constipation. There might also be risks associated with frequently sampled intravenous glucose tolerance tests.

PORT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed after completing 6 weeks of semaglutide therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed after completing 6 weeks of semaglutide therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Insulin
Rate of glucose disappearance
Second phase insulin secretion
Secondary outcome measures
Weight loss
Other outcome measures
Glucose effectiveness (Sg)
Insulin sensitivity (Si)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

PORT Trial Design

1Treatment groups
Experimental Treatment
Group I: Open label administration of semaglutideExperimental Treatment1 Intervention
Semaglutide: 0.25 mg, sc, q.week for 4 weeks followed by 0.5 mg, sc, q.week for 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide Pen Injector [Ozempic]
2021
Completed Phase 4
~90

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
681 Previous Clinical Trials
370,655 Total Patients Enrolled
4 Trials studying Diabetes
23,990 Patients Enrolled for Diabetes
Amber L Beitelshees, PharmDPrincipal InvestigatorUniversity of Maryland, Baltimore

Media Library

Semaglutide (GLP1R Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05071898 — Phase 1
Diabetes Research Study Groups: Open label administration of semaglutide
Diabetes Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05071898 — Phase 1
Semaglutide (GLP1R Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05071898 — Phase 1
Diabetes Patient Testimony for trial: Trial Name: NCT05071898 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA confirmed Semaglutide Pen Injector [Ozempic] for public use?

"As this trial is in Phase 1, the safety of Semaglutide Pen Injector [Ozempic] was rated as a score of 1 due to limited clinical evidence for efficacy and security."

Answered by AI

Are individuals aged 50 and above eligible to partake in this scientific experiment?

"This clinical trial is open to individuals above the age of majority and below their 89th year."

Answered by AI

What medical issues has Semaglutide Pen Injector [Ozempic] been approved to address?

"The Semaglutide Pen Injector [Ozempic] can be leveraged to tackle the challenges of long-term weight management, low caloric diets, and physical activity."

Answered by AI

What is the aggregate amount of individuals that are engaging in this medical evaluation?

"Affirmative. According to the clinicaltrials.gov registry, this investigation is currently accepting participants and was first listed on April 11th 2022 with an update made July 29th of that same year. 600 individuals are sought from a solitary medical centre for inclusion in the study."

Answered by AI

Is this medical trial a pioneering endeavor?

"Presently, 58 ongoing trials for Semaglutide Pen Injector [Ozempic] are located in 55 countries and 772 cities. Starting with its Phase 4 drug approval study from 2018 sponsored by Novo Nordisk A/S , there have been 123 separate clinical studies conducted involving 1387 patients."

Answered by AI

What findings have been documented from experiments with Semaglutide Pen Injector [Ozempic]?

"Currently, 58 trials are underway concerning Semaglutide Pen Injector [Ozempic], with 27 of them at the final stage. While primarily centered in Loma Linda, California, there is research being conducted across 3907 different locations worldwide."

Answered by AI

Is it possible to join the clinical trial?

"This clinical trial requires 600 Amish participants, aged between 18 and 89 years old, who are also overweight or obese (BMI ≥ 27 kg/m2)."

Answered by AI

Is this research actively recruiting new participants?

"The information posted on clinicaltrials.gov reveals that this medical experiment is currently recruiting participants. It was initially published on April 11th 2022 and the latest update was July 29th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Pennsylvania
Other
New Jersey
How old are they?
18 - 65
What site did they apply to?
Amish Research Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I want to lose weight but can't afford medicine. I have been using this drug out of pocket, because my insurance won’t cover it. I lost 21 pounds but cannot continue to pay out of pocket.
PatientReceived 2+ prior treatments
~360 spots leftby Nov 2026