A Study of RAY1225 in Participants With Type 2 Diabetes

NCT ID: NCT06254274

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-26
• Study Completion Date: 2025-12-20

Brief Summary

The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with type 2 diabetes mellitus. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Study Design

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

Study Groups

RAY1225 (cohort 1)

Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

Administered SC

Placebo (cohort 1)

Participants received Placebo administered SC once two weeks for 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

RAY1225 (cohort 2)

Escalating doses of RAY1225 administered subcutaneously (SC) once two week

Group Type: EXPERIMENTAL

RAY1225

Intervention Type: DRUG

Administered SC

Placebo (cohort 2)

Participants received Placebo administered SC once 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. Type 2 diabetes had been diagnosed for at least 12 weeks prior to screening and one of the following conditions:

1. have T2DM controlled with diet and exercise alone;

2. are stable in dose and type on a single or in a combination of oral antidiabetic medication, metformin, α-glucosidase inhibitors or SGLT-2 inhibitors only ,within 12 weeks before screening;

2. BMI ≥ 20 kg/m²；

3. Fasting blood-glucose（FPG）<15 mmol/L;

4. Weight change < 5% in the 12 weeks before screening;

5. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

Exclusion Criteria

1. have type 1 diabetes mellitus；

2. Severe diabetic complications, including proliferative retinopathy or maculopathy, severe diabetic neuropathy (e.g., urinary retention, urinary incontinence, and painful peripheral neuropathy), resting tachycardia, orthostatic hypotension, intermittent claudication, or diabetic foot;

3. Two or more episodes of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 24 weeks before screening;

4. had grade 3 hypoglycemic events within 12 months before screening,

5. Three or more grade 2 hypoglycemic events occurred within 3 months before screening;

6. Have symptoms related to hypoglycemia at screening;

7. Within 6 weeks before screening, serious trauma, serious infection, or surgery that may have affected glycemic control was reported;

8. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.

9. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 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

Other Identifiers

RAY1225-23-03

Identifier Type: -

Identifier Source: org_study_id