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Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
300
estimated
Study population
Prediabetes / glucose intolerance
Key I/E criteria
•BMI ≥30•HbA1c 5.7-6.4%•eGFR ≥60
Primary endpoints
•Beta cell responsivity•HOMA-IR (insulin sensitivity)•Disposition Index
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Men and women, ages 18 years and older
2. Diagnosis of Prediabetes - defined as either impaired fasting glucose (fasting glucose of 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 a hemoglobin A1C ranging from 5.7% to 6.4%
3. High risk for progression to diabetes: defined as having at least one of the two following additional factors: Obesity (BMI ≥ 30 kg/m2) and/or metabolically unhealthy status. "Metabolically unhealthy status" is defined as at least two of the following: elevated blood pressure (SBP ≥ 130 mmHg and/or DBP ≥ 85 mmHg), elevated triglycerides ≥ 150 mg/dL, low HDL cholesterol (males < 40 mg/dL; females < 50 mg/dL), and elevated fasting glucose ≥ 100 mg/dL (Wu S et al., 2017).
4. Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, hormonal contraception, intrauterine contraception, or surgical sterilization) for the duration of the study.
5. Patients must have the following laboratory values: Hematocrit ≥ 34 vol%, estimated glomerular filtration rate ≥ 60 mL/min per 1.73 m2, AST (SGOT) < 2.5 times ULN, ALT (SGPT) < 2.5 times ULN, alkaline phosphatase < 2.5 times ULN
Exclusion criteria
1. History of Type 1 or Type 2 diabetes mellitus
2. Pregnant or breastfeeding women
3. Medications: metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, insulin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, and/or corticosteroids over the last 3 months.
4. Active malignancy
5. History of clinically significant cardiac, hepatic, pancreatic or renal disease.
6. History of any serious hypersensitivity reaction to the study medication (or any other incretin mimetic)
7. Prisoners or subjects who are involuntarily incarcerated
8. Prior history of pancreatitis, medullary thyroid cancer, or multiple endocrine neoplasia type 2 (MEN 2)
9. Family history of medullary thyroid cancer (a rare form of thyroid cancer) or MEN2. However, as many individuals may not be aware of the specific type of thyroid cancer, will also exclude any family history of thyroid cancer or MEN2.
10. Hospitalization for COVID-19 in last 3 months
Endpoints (23)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Glycemic / diabetes
8 endpointsMean change in beta cell responsivity
Time frame:12 weeks
change from baseline, improvement
Insulin Sensitivity
Time frame:12 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Disposition Index
Time frame:12 weeks
change from baseline, improvement
GLP-1-Induced Potentiation
Time frame:12 weeks
descriptive
Mean change in glucose Area Under the Curve (AUC)
Time frame:12 weeks
Postprandial glucose
change from baseline, improvement
Mean change in C-peptide Area Under the Curve (AUC)
Time frame:12 weeks
C-peptide AUC
change from baseline, improvement
Change in hemoglobin A1C
Time frame:12 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Mean change in insulin Area Under the Curve (AUC)
Time frame:12 weeks
change from baseline, improvement
Safety / tolerability / PK
1 endpointMean change in GLP-1 Area Under the Curve (AUC)
Time frame:12 weeks
concentration, descriptive
Other (unclassified)
14 endpointsGene expression changes for minor variants of eQTLs for TCF7L2
Time frame:12 weeks
change from baseline, descriptive
Gene expression changes for minor variants of eQTLs for KCNQ1
Time frame:12 weeks
descriptive
Gene expression changes for minor variants of eQTLs for WFS1
Time frame:12 weeks
descriptive
Gene expression changes for minor variants of eQTLs for THADA
Time frame:12 weeks
change from baseline, descriptive
Gene expression changes for minor variants of eQTLs for CNR1
Time frame:12 weeks
change from baseline, descriptive
Gene expression changes for minor variants of eQTLs for CTRB1
Time frame:12 weeks
change from baseline, descriptive
Gene expression changes for minor variants of eQTLs for CTRB2
Time frame:12 weeks
change from baseline, descriptive
Gene expression changes for minor variants of eQTLs for GLP1R
Time frame:12 weeks
change from baseline, descriptive
Gene expression changes for minor variants of eQTLs for CHST3
Time frame:12 weeks
change from baseline, descriptive
Gene expression changes for minor variants of eQTLs for MTNR1B
Time frame:12 weeks
change from baseline, descriptive
Gene expression changes for minor variants of eQTLs for SORCS1
Time frame:12 weeks
change from baseline, descriptive
Previously unidentified cis-eQTLs associated with change in gene expression due to GLP-1 challenge
Time frame:12 weeks
descriptive
Creation of eQTL-based disease prediction models
Time frame:5 years
descriptive
Polygenic prediction model for GLP-1 therapy-associated outcomes
Time frame:5 years
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.