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

Official title

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

Overview

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.

Interventions

• Drug RAY1225
  Administered SC
• Drug placebo
  Administered SC

Primary outcome measures

• Change From Baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline,36 Week]

Secondary outcome measures (4)

• Percentage of Participants Achieving an HbA1c Target Value of <7% [Time frame: Baseline,36 Week]
• Percentage of Participants With HbA1c Target Value of <6.5% [Time frame: Baseline,36 Week]
• Mean change in fasting serum glucose [Time frame: Baseline,36 Week]
• Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline [Time frame: Baseline,36 Week]

Eligibility criteria

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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University People's Hospital — Beijingcun

Identifiers

NCT: NCT07139535 · RAY1225-24-12

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗