← Trials/Trial dossier/NCT07139548
A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes
A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Patients With Type 2 Diabetes
Lead sponsor
Assets
RAY1225 / Semaglutide
Listed sites
1
Recruiting sites
—
Enrollment
600
estimated
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≥20•HbA1c 7-11.5%
Primary endpoint
•HbA1c, change
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. Have been diagnosed with type 2 diabetes mellitus (T2DM)
2. Have HbA1c between ≥7.0% and ≤11.5%
3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
4. Be of stable weight (±5%) for at least 12 weeks before screening
Exclusion criteria
1. Have type 1 diabetes mellitus
2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;
3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose <3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;
5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);
7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).
Endpoints (6)
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
1 endpointProportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline
Time frame:Baseline,36 Week
≥5% weight-loss responders
threshold achievement, improvement
Glycemic / diabetes
5 endpointsChange From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg)
Time frame:Baseline,36 Week
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Percentage of Participants Achieving an HbA1c Target Value of <7%
Time frame:Baseline,36 Week
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Percentage of Participants With HbA1c Target Value of <6.5%
Time frame:Baseline,36 Week
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Percentage of Participants With HbA1c Target Value of <5.7%
Time frame:Baseline,36 Week
HbA1c <5.7% achievement
threshold achievement, improvement
LOINC 4548-4
Mean change in fasting serum glucose
Time frame:Baseline,36 Week
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
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.