A Study of RAY1225 in Participants With Type 2 Diabetes

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Type 2 Diabetes

The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with type 2 diabetes mellitus. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.

Study Overview

• Status: Active, not recruiting
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: Placebo; Drug: RAY1225

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei
    • Beijing, Hebei, China
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Type 2 diabetes had been diagnosed for at least 12 weeks prior to screening and one of the following conditions:

   1. have T2DM controlled with diet and exercise alone;
   2. are stable in dose and type on a single or in a combination of oral antidiabetic medication, metformin, α-glucosidase inhibitors or SGLT-2 inhibitors only ,within 12 weeks before screening;
2. BMI ≥ 20 kg/m²；
3. Fasting blood-glucose（FPG）<15 mmol/L;
4. Weight change < 5% in the 12 weeks before screening;
5. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

Exclusion Criteria:

1. have type 1 diabetes mellitus；
2. Severe diabetic complications, including proliferative retinopathy or maculopathy, severe diabetic neuropathy (e.g., urinary retention, urinary incontinence, and painful peripheral neuropathy), resting tachycardia, orthostatic hypotension, intermittent claudication, or diabetic foot;
3. Two or more episodes of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 24 weeks before screening;
4. had grade 3 hypoglycemic events within 12 months before screening,
5. Three or more grade 2 hypoglycemic events occurred within 3 months before screening;
6. Have symptoms related to hypoglycemia at screening;
7. Within 6 weeks before screening, serious trauma, serious infection, or surgery that may have affected glycemic control was reported;
8. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.
9. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAY1225 (cohort 1); Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.	Drug: RAY1225; Administered SC
Placebo Comparator: Placebo (cohort 1); Participants received Placebo administered SC once two weeks for 24 weeks.	Drug: Placebo; Administered SC
Experimental: RAY1225 (cohort 2); Escalating doses of RAY1225 administered subcutaneously (SC) once two week	Drug: RAY1225; Administered SC
Placebo Comparator: Placebo (cohort 2); Participants received Placebo administered SC once two week	Drug: Placebo; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)	HbA1c is the glycosylated fraction of hemoglobin A.	Baseline,Week 26

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With HbA1c Target Value of <6.5%	Baseline,Week26
Percentage of Participants With HbA1c Target Value of <7%	Baseline,Week26
Percentage of Participants With HbA1c Target Value of <5.7%	Baseline,Week26
Change From Baseline in Fasting Serum Glucose	Baseline,Week26

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: February 3, 2024
• First Submitted That Met QC Criteria: February 3, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: RAY1225-23-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No