Testing RAY1225 for managing Type 2 Diabetes

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Type 2 Diabetes

This study is testing a new medication called RAY1225 to see if it can help people with Type 2 Diabetes manage their blood sugar levels better than a placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Guangdong Raynovent Biotech Co., Ltd (Industry-sponsored)
• Locations: 1 site (Beijing, Hebei)
• Trial ID: NCT06254274 on ClinicalTrials.gov

What this trial studies

This study evaluates the tolerability and efficacy of RAY1225 in individuals diagnosed with Type 2 Diabetes Mellitus (T2DM). Participants will receive either RAY1225 or a placebo over a period of six months. The study aims to determine how well RAY1225 can help manage blood sugar levels and its overall safety profile. Eligible participants include those with controlled diabetes through diet, exercise, or specific oral medications.

Who should consider this trial

Good fit: Ideal candidates are adults with Type 2 Diabetes diagnosed for at least 12 weeks, who are either managing their condition through diet and exercise or stable on certain oral medications.

Not a fit: Patients with Type 1 Diabetes or severe diabetic complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with Type 2 Diabetes, potentially improving their blood sugar control.

How similar studies have performed: While there have been studies on diabetes treatments, the specific approach with RAY1225 is novel and has not been extensively tested in prior trials.

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)

Where this trial is running

Beijing, Hebei

• Peking University People's Hospital — Beijing, Hebei, China (Recruiting)

Study contacts

• Study coordinator: JI, professor

Conditions T2DM