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

NCT ID: NCT07139548

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

T2DM

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

6mg RAY1225

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

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

Administered SC

9mg RAY1225

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

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

Administered SC

1 mg Semaglutide

1 mg semaglutide administered SC once a week.

Group Type: ACTIVE_COMPARATOR

Semaglutide

Intervention Type: DRUG

Administered SC

Interventions

RAY1225

Administered SC

Intervention Type: DRUG

Semaglutide

Administered SC

Intervention Type: DRUG

Eligibility 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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Raynovent Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, Heibei, China

Countries

China

Central Contacts

Ji professor

Role: CONTACT

iao@pkuph.edu.cn

88326666

Facility Contacts

Ji professor

Role: primary

Other Identifiers

RAY1225-24-13

Identifier Type: -

Identifier Source: org_study_id