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NCT Number: NCT07139535

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijingcun, Hebei, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

RAY1225

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. Change From Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline,36 Week

    HbA1c is the glycosylated fraction of hemoglobin A.

Secondary outcomes

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

    Time frame: Baseline,36 Week

  2. Percentage of Participants With HbA1c Target Value of <6.5%

    Time frame: Baseline,36 Week

  3. Mean change in fasting serum glucose

    Time frame: Baseline,36 Week

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

    Time frame: Baseline,36 Week

Study contacts

Contact information is provided by the study sponsor or research team.

JI professor

CONTACT

[email protected]

88326666

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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