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Starting soon Phase 3

A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes

NCT07139548 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-08-31
Last updated
2025-08-24

Condition(s) studied

T2DM

Investigational drug(s) / intervention(s)

RAY1225 →Semaglutide →

RAY1225: Administered SC

Semaglutide: Administered SC

Study summary

The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.).

Primary outcome measure(s)

  • Change From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg) — Baseline,36 Week
    HbA1c is the glycosylated fraction of hemoglobin A.

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Heibei
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07139548 on ClinicalTrials.gov ↗ ← All trials in China