Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06254274 | RECRUITING | T2DM (Type 2 Diabetes Mellitus)

A Study of RAY1225 in Participants With Type 2 Diabetes
Sponsor:

Guangdong Raynovent Biotech Co., Ltd

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.

Condition or disease

T2DM (Type 2 Diabetes Mellitus)

Intervention/treatment

RAY1225

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 270 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Type 2 Diabetes
Actual Study Start Date : 2024-02-26
Estimated Primary Completion Date : 2025-12-20
Estimated Study Completion Date : 2025-12-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
A Study of RAY1225 in Participants With Type 2 Diabetes

Location Details

NCT06254274

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Hebei

Peking University People's Hospital

Beijing, Hebei, China,