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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07139548
• Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

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.

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: 600

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6mg RAY1225	RAY1225	6 milligrams (mg) RAY1225 administered subcutaneously (SC) once every two week.
9mg RAY1225	RAY1225	9 mg RAY1225 administered subcutaneously (SC) once every two week.
1 mg Semaglutide	Semaglutide	1 mg semaglutide administered SC once a week.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg)	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
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
Percentage of Participants With HbA1c Target Value of <6.5%	Baseline,36 Week
Percentage of Participants With HbA1c Target Value of <5.7%	Baseline,36 Week

Trial Locations

Locations (1)

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