Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care
Comparison of Oral Semaglutide With Matched Oral Semaglutide Placebo as an Early Treatment for Latino Adults With Type 2 Diabetes Receiving Enhanced Lifestyle Care
Lead sponsor
Asset
Semaglutide
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
12
Study population
Type 2 diabetes
Eligibility highlights
•HbA1c 7.5-10%
Primary endpoint
•HbA1c <7.0% achievement
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Individuals ≥ 18 years of age at enrollment.
2. Self-reported Hispanic/Latino heritage.
3. Established diagnosis of T2D for at least 3 months prior to enrollment date.
4. HbA1c > 7.5% and ≤ 10.0% (58-86 mmol/mol) within the previous 6 months.
5. T2D treated with lifestyle alone or lifestyle + Metformin within the past 6 months prior to screening.
6. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.
7. Based on the research staff's judgment, participant or participant's representative must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion of the study.
Exclusion criteria
1. Type 1 diabetes or a history of diabetic ketoacidosis.
2. T2D treated with oral medicines other than Metformin or any injectable GLP-1 receptor agonist or insulin within the past 6 months prior to screening.
3. Life expectancy < 12 months.
4. Any active clinically significant physical or mental disease or disorder which, in the investigator's opinion, could interfere with the participation in the study.
5. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
6. Untreated pre-proliferative or proliferative retinopathy or maculopathy due to diabetes.
7. Renal impairment, defined as estimated glomerular filtration rate <30 mL/min/1.73 m2.
8. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
9. Language barriers precluding comprehension of study activities and informed consent.
10. Participation in other research studies involving medication or device within 1 month prior to enrollment.
11. Known or suspected abuse of alcohol, narcotics, or illicit drugs.
12. Known or suspected allergy to OS, excipients, or related products.
13. Previous participation in this trial whether screened or randomized.
14. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
15. The receipt of any investigational drug (within 12 months) prior to this trial.
Endpoints (14)
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
Weight & body composition
2 endpointsWeight
Time frame:At 50 weeks
change from baseline, improvement
Waist circumference
Time frame:At 50 weeks
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
7 endpointsHbA1c < 7.0%
Time frame:At 50 weeks
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
HbA1c
Time frame:At 50 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Fasting glucose levels
Time frame:At 50 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Fasting insulin levels
Time frame:At 50 weeks
change from baseline, improvement
Calculation of insulin resistance (HOMA-B and HOMA-IR)
Time frame:At 50 weeks
HOMA-IR (insulin sensitivity)
change from baseline, improvement
CGM Time In Range
Time frame:Weeks 48-49
CGM time-in-range
change from baseline, improvement
Additional glucose-lowering medication (rescue medication)
Time frame:Comparison at 4, 8, 22, 34, and 48 weeks
categorical status, event
MASH / liver
1 endpointLiver Function Test
Time frame:Comparison with baseline (-2 weeks) and at 50 weeks
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsLying and standing blood pressure
Time frame:At 50 weeks
change from baseline, improvement
Lipid Levels
Time frame:Comparison with baseline (-2 weeks) and at 50 weeks
change from baseline, improvement
Safety / tolerability / PK
1 endpointNumber of participants with treatment-related adverse events assessed by research physician classified according to Good Clinical Practice guidelines
Time frame:Data captured at baseline
Treatment-emergent AEs (any)
event count, event
Other (unclassified)
1 endpointNumber of Pill Counts
Time frame:Comparison at 4, 8, 22, 34, and 48 weeks
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 6, 2026 snapshot.