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

NCT07139535 | Not Yet Recruiting Phase 3

• 1 other identifier: RAY1225-24-12
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

T2DM

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c)

  HbA1c is the glycosylated fraction of hemoglobin A.

  Baseline,36 Week

Secondary Outcomes (4)

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

  Baseline,36 Week

• Percentage of Participants With HbA1c Target Value of <6.5%

  Baseline,36 Week

• Mean change in fasting serum glucose

  Baseline,36 Week

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

  Baseline,36 Week

Study Arms (4)

3mg RAY1225

EXPERIMENTAL

Participants received 3 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.

Drug: RAY1225

6mg RAY1225

EXPERIMENTAL

Participants received 6 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.

Drug: RAY1225

9mg RAY1225

EXPERIMENTAL

Participants received 9 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.

Drug: RAY1225

Placebo

PLACEBO COMPARATOR

Participants received placebo as subcutaneous injection once every two week.

Drug: placebo

Interventions

RAY1225 DRUG

Administered SC

3mg RAY1225; 6mg RAY1225; 9mg RAY1225

placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijingcun, Hebei, China

Location

Central Study Contacts

JI professor

CONTACT

88326666; iao@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 24, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)