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

Guangdong Raynovent Biotech

Status and phase: Not yet enrolling; Phase 3

Conditions: T2DM

Treatments: Drug: Semaglutide; Drug: RAY1225

Study type: Interventional

Funder types: Industry

Identifiers

NCT07139548

RAY1225-24-13

Details and patient eligibility

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

600 participants in 3 patient groups

6mg RAY1225

Experimental group

Description:

6 milligrams (mg) RAY1225 administered subcutaneously (SC) once every two week.

Treatment:

Drug: RAY1225

9mg RAY1225

Experimental group

Description:

9 mg RAY1225 administered subcutaneously (SC) once every two week.

Treatment:

Drug: RAY1225

1 mg Semaglutide

Active Comparator group

Description:

1 mg semaglutide administered SC once a week.

Treatment:

Drug: Semaglutide