About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 ;
Trial design
Parallel
Treatments tested in this trial
RAY1225
DrugAdministered SC
placebo
DrugAdministered SC
Treatment groups
Trial outcomes
Primary outcomes
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A.
Secondary outcomes
Percentage of Participants Achieving an HbA1c Target Value of <7%
Percentage of Participants With HbA1c Target Value of <6.5%
Mean change in fasting serum glucose
Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline
Sponsors and contacts
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