Not Yet RecruitingPhase 3

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

China350 participantsStarted 2025-08-31

Plain-language summary

The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Have been diagnosed with type 2 diabetes mellitus (T2DM)
✓. 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.
✓. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
✓. Be of stable weight (±5%) for at least 12 weeks before screening

Exclusion criteria

✕. Have type 1 diabetes mellitus
✕. 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;
✕. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
✕. 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 ;
✕. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
✕. 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.);
✕. 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.).

What they're measuring

Change From Baseline in Hemoglobin A1c (HbA1c)

Timeframe: Baseline,36 Week

Trial details

NCT IDNCT07139535

SponsorGuangdong Raynovent Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

JI professor

88326666 iao@pkuph.edu.cn

View on ClinicalTrials.gov More T2DM trials