← Trials/Trial dossier/NCT06254274

Active not recruitingPhase 2

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

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

NCT IDNCT06254274
Org study IDRAY1225-23-03

Timeline

Milestones

Study first posted2024-02-12actual
Study start2024-02-26actual
Last update posted2025-08-05actual
Primary completion2025-12-20estimated
Study completion2025-12-20estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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 endpoints
Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline,Week 26

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Value of <6.5%

Time frame:Baseline,Week26

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Value of <7%

Time frame:Baseline,Week26

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Value of <5.7%

Time frame:Baseline,Week26

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose

Time frame:Baseline,Week26

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.