A Study of RAY1225 in Participants With Type 2 Diabetes

NCT06254274 | Active Not Recruiting Phase 2

• 1 other identifier: RAY1225-23-03
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c)

  HbA1c is the glycosylated fraction of hemoglobin A.

  Baseline,Week 26

Secondary Outcomes (4)

• 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

Study Arms (4)

RAY1225 (cohort 1)

EXPERIMENTAL

Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.

Drug: RAY1225

Placebo (cohort 1)

PLACEBO COMPARATOR

Participants received Placebo administered SC once two weeks for 24 weeks.

Drug: Placebo

RAY1225 (cohort 2)

EXPERIMENTAL

Escalating doses of RAY1225 administered subcutaneously (SC) once two week

Drug: RAY1225

Placebo (cohort 2)

PLACEBO COMPARATOR

Participants received Placebo administered SC once two week

Drug: Placebo

Interventions

RAY1225 DRUG

Administered SC

RAY1225 (cohort 1); RAY1225 (cohort 2)

Placebo DRUG

Administered SC

Placebo (cohort 1); Placebo (cohort 2)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes had been diagnosed for at least 12 weeks prior to screening and one of the following conditions:
• have T2DM controlled with diet and exercise alone;
• 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;
• BMI ≥ 20 kg/m²；
• Fasting blood-glucose（FPG）\<15 mmol/L;
• Weight change \< 5% in the 12 weeks before screening;
• Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

You may not qualify if:

• have type 1 diabetes mellitus；
• 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;
• Two or more episodes of ketoacidosis, lactic acidosis, or hyperosmolar state leading to hospitalization within 24 weeks before screening;
• had grade 3 hypoglycemic events within 12 months before screening,
• Three or more grade 2 hypoglycemic events occurred within 3 months before screening;
• Have symptoms related to hypoglycemia at screening;
• Within 6 weeks before screening, serious trauma, serious infection, or surgery that may have affected glycemic control was reported;
• 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.
• Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening)

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijingcun, Hebei, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 12, 2024
• Study Start: February 26, 2024
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-03

Locations

CN (1)