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A Study of RAY1225 in Participants With 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
Lead sponsor
Asset
RAY1225
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
210
actual
Study population
Type 2 diabetes
Key I/E criterion
•BMI ≥20
Primary endpoint
•Hemoglobin A1c (HbA1c)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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)
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Glycemic / diabetes
5 endpointsChange From Baseline in Hemoglobin A1c (HbA1c)
Time frame:Baseline,Week 26
change from baseline, improvement
Percentage of Participants With HbA1c Target Value of <6.5%
Time frame:Baseline,Week26
threshold achievement, improvement
Percentage of Participants With HbA1c Target Value of <7%
Time frame:Baseline,Week26
threshold achievement, improvement
Percentage of Participants With HbA1c Target Value of <5.7%
Time frame:Baseline,Week26
threshold achievement, improvement
Change From Baseline in Fasting Serum Glucose
Time frame:Baseline,Week26
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.