A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

NCT ID: NCT07139535

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-12-31

Brief Summary

The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.

Conditions

T2DM

Study Design

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

Study Groups

3mg RAY1225

Participants received 3 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

Administered SC

6mg RAY1225

Participants received 6 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

Administered SC

9mg RAY1225

Participants received 9 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

Administered SC

Placebo

Participants received placebo as subcutaneous injection once every two week.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Administered SC

Interventions

RAY1225

Administered SC

Intervention Type: DRUG

placebo

Administered SC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Have been diagnosed with type 2 diabetes mellitus (T2DM)

2. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.

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

Beijingcun, Hebei, China

Countries

China

Central Contacts

JI professor

Role: CONTACT

iao@pkuph.edu.cn

88326666

Other Identifiers

RAY1225-24-12

Identifier Type: -

Identifier Source: org_study_id