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

Guangdong Raynovent Biotech

Status and phase: Not yet enrolling; Phase 3

Conditions: T2DM

Treatments: Drug: placebo; Drug: RAY1225

Study type: Interventional

Funder types: Industry

Identifiers

NCT07139535

RAY1225-24-12

Details and patient eligibility

About

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.

Enrollment: 350 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. 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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 4 patient groups, including a placebo group

3mg RAY1225

Experimental group

Description:

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

Treatment:

Drug: RAY1225

6mg RAY1225

Experimental group

Description:

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

Treatment:

Drug: RAY1225

9mg RAY1225

Experimental group

Description:

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

Treatment:

Drug: RAY1225

Placebo

Placebo Comparator group

Description:

Participants received placebo as subcutaneous injection once every two week.

Treatment:

Drug: placebo