A Study of RAY1225 in Participants With Type 2 Diabetes

Launched by GUANGDONG RAYNOVENT BIOTECH CO., LTD · Feb 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called RAY1225 to see how well it works and how well people tolerate it in managing type 2 diabetes (T2DM). The researchers aim to understand if RAY1225 can help lower blood sugar levels in people who have had diabetes for at least 12 weeks. The study is open to adults aged between 65 and 74 and those between 25 and 66, and it lasts about six months for each participant.

To join the study, participants need to have type 2 diabetes that is either managed through diet and exercise or controlled with specific oral medications. They should also have a body mass index (BMI) of 20 or higher and meet certain blood sugar level requirements. However, individuals with type 1 diabetes or severe complications from diabetes won't be eligible. Throughout the study, participants will take the medication and have regular check-ups to see how they're doing. It’s important for participants to use reliable birth control during the study and for six months afterward. If you think you might qualify or are interested in learning more, please reach out to the study team.

Gender

ALL

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)