Clinical trial

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

Opening soon · Phase 3 · 1 countries · Registry ID NCT07139548

Opening soonPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionT2DM

Full registry criteria

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.).

Treatments and study arms

RAY1225

Drug

Administered SC

Semaglutide

Drug

Administered SC

Primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg)Baseline,36 Week

HbA1c is the glycosylated fraction of hemoglobin A.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Peking University People's Hospital🇨🇳 Beijing, Heibei, China
Ji professorContact