A Study of RAY1225 in Participants With Type 2 Diabetes

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254274
• Other study ID #: RAY1225-23-03
• Status: Recruiting
• Phase: Phase 2
• Start date: February 26, 2024
• Est. completion date: February 20, 2025

Study information

• Verified date: February 2024
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: JI, professor
• Phone: 88326666
• Email: iao[@]pkuph.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: February 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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, a-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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• RAY1225
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c)	HbA1c is the glycosylated fraction of hemoglobin A.	Baseline,Week 26
Secondary	Percentage of Participants With HbA1c Target Value of <6.5%		Baseline,Week26
Secondary	Percentage of Participants With HbA1c Target Value of <7%		Baseline,Week26
Secondary	Percentage of Participants With HbA1c Target Value of <5.7%		Baseline,Week26
Secondary	Change From Baseline in Fasting Serum Glucose		Baseline,Week26