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

Not Applicable

Not yet recruiting

• Conditions: T2DM
• Interventions: Drug: RAY1225; Drug: placebo

• Registration Number: NCT07139535
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Study Start: 2025-08-31
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3mg RAY1225	RAY1225	Participants received 3 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.
6mg RAY1225	RAY1225	Participants received 6 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.
9mg RAY1225	RAY1225	Participants received 9 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.
Placebo	placebo	Participants received placebo as subcutaneous injection once every two week.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c)	Baseline,36 Week	HbA1c is the glycosylated fraction of hemoglobin A.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving an HbA1c Target Value of <7%	Baseline,36 Week
Percentage of Participants With HbA1c Target Value of <6.5%	Baseline,36 Week
Mean change in fasting serum glucose	Baseline,36 Week
Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline	Baseline,36 Week

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Hebei, China