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Glucagon-like peptide-1 (GLP-1) receptor agonist

Semaglutide for Prediabetes

Phase 4
Recruiting
Led By Absalon D Gutierrez, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Prediabetes - defined as impaired fasting glucose (100-125 mg/dL), impaired glucose tolerance (2-hour postprandial blood glucose of 140-199 mg/dL after 75-gram oral glucose challenge), and/or hemoglobin A1C ranging from 5.7% to 6.4%
Men and women, ages 18 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will help researchers understand why some people respond better to the diabetes drug GLP-1 than others, which could lead to more personalized treatments for diabetes and related diseases.

Who is the study for?
This trial is for Mexican-Americans with prediabetes, particularly those at high risk of developing diabetes due to obesity or metabolic issues. Participants must be adults with specific blood and kidney function levels, and women who can have children should use birth control during the study. People taking certain diabetes medications or with a history of serious diseases like pancreatitis, thyroid cancer, or active malignancy cannot join.Check my eligibility
What is being tested?
The trial is studying how people respond to Semaglutide—a drug that mimics a hormone important for lowering blood sugar and aiding weight loss—by looking at their genes and gene activity. The goal is to understand why different people react differently to this treatment.See study design
What are the potential side effects?
Semaglutide may cause digestive problems (like nausea or diarrhea), potential allergic reactions, increased heart rate, possible inflammation of the pancreas (pancreatitis), changes in vision if you have diabetic retinopathy, and low blood sugar when used with other diabetes medicines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood sugar levels indicate I have prediabetes.
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I am 18 years old or older.
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I agree to use birth control during the study.
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I am at high risk for diabetes due to obesity or unhealthy metabolism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disposition Index
GLP-1-Induced Potentiation
Gene expression changes for minor variants of eQTLs for CHST3
+14 more
Secondary outcome measures
Change in hemoglobin A1C
Creation of eQTL-based disease prediction models
Mean change in C-peptide Area Under the Curve (AUC)
+3 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: SemaglutideExperimental Treatment1 Intervention
Semaglutide 0.25 mg subcutaneously weekly for 4 weeks, followed by semaglutide 0.5 mg subcutaneously weekly for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,639 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
853 Previous Clinical Trials
670,768 Total Patients Enrolled
Absalon D Gutierrez, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
23 Total Patients Enrolled

Media Library

Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05119179 — Phase 4
Prediabetes Research Study Groups: Semaglutide
Prediabetes Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05119179 — Phase 4
Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05119179 — Phase 4

Frequently Asked Questions

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

Is Semaglutide currently certified by the FDA?

"The safety of semaglutide is rated a 3, as this is a Phase 4 trial demonstrating the treatment's approval."

Answered by AI

How many individuals are enrolling in this trial?

"Affirmative, the clinical trial is presently recruiting patients as per information displayed on clinicaltrials.gov. This research project was advertised on November 22nd 2021 and last updated on March 15th 2022. Its goal is to recruit 300 individuals from 1 site for assessment purposes."

Answered by AI

Has recruitment for this study already begun?

"The clinicaltrials.gov website confirms that this medical trial is currently looking for individuals to join, with the original posting date being November 22nd 2021 and an update on March 15th 2022."

Answered by AI

What are the underlying objectives of this experiment?

"The primary goal of this medical trial is to assess Insulin Sensitivity over a 12 week period. Additionally, the Mean change in insulin Area Under the Curve (AUC), glucose AUC, and C-peptide AUC will be evaluated as Secondary Outcomes based on pre and post drug intervention data."

Answered by AI

What afflictions can be ameliorated through Semaglutide treatment?

"Semaglutide can be a viable treatment option for long-term weight management, dietary restriction of caloric intake, and the promotion of physical activity."

Answered by AI

Is this a pioneering clinical trial?

"At present, the drug Semaglutide is being tested in 58 extant clinical trials across 772 cities and 55 nations. Novo Nordisk A/S began researching this treatment back in 2018 with a Phase 4 study involving 1387 patients; since then, 124 studies have been conducted."

Answered by AI

Has there been additional research conducted on Semaglutide?

"Currently, there are 58 clinical trials for Semaglutide in progress. 27 of these studies are classified as Phase 3 and the majority take place at Loma Linda, California; however, 3907 other medical research centres across the globe have enrolled patients to test this particular drug."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
UTHealth Clinical Research Unit (CRU) at UT Brownsville
What portion of applicants met pre-screening criteria?
Met criteria
~121 spots leftby Nov 2025