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Not yet recruitingPhase 3

A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of RAY1225 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone

Asset

RAY1225

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

350

estimated

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 IDNCT07139535
Org study IDRAY1225-24-12

Timeline

Milestones

Study first posted2025-08-24actual
Last update posted2025-08-24actual
Study start2025-08-31estimated
Primary completion2026-12-01estimated
Study completion2026-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Have been diagnosed with type 2 diabetes mellitus (T2DM)

2. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.

3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening

4. Be of stable weight (±5%) for at least 12 weeks before screening

Exclusion criteria

1. Have type 1 diabetes mellitus

2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;

3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;

4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose <3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;

5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;

6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);

7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).

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.

Coverage by outcome category

Glycemic / diabetes
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline

Time frame:Baseline,36 Week

threshold achievement, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline,36 Week

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving an HbA1c Target Value of <7%

Time frame:Baseline,36 Week

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With HbA1c Target Value of <6.5%

Time frame:Baseline,36 Week

threshold achievement, improvement

Secondary/protocol endpoint

Mean change in fasting serum glucose

Time frame:Baseline,36 Week

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.