NCT06254274进行中（未招募）2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants With Type 2 Diabetes
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年2月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
RAY1225 (cohort 1)
Experimental
Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks.
干预措施: RAY1225 (Drug)
Placebo (cohort 1)
Placebo Comparator
Participants received Placebo administered SC once two weeks for 24 weeks.
干预措施: Placebo (Drug)
RAY1225 (cohort 2)
Experimental
Escalating doses of RAY1225 administered subcutaneously (SC) once two week
干预措施: RAY1225 (Drug)
Placebo (cohort 2)
Placebo Comparator
Participants received Placebo administered SC once two week
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline,Week 26
HbA1c is the glycosylated fraction of hemoglobin A.
次要结局
- 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)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
A Study of RAY1225 in Participants With ObesityObesityNCT06254261Guangdong Raynovent Biotech Co., Ltd270
已完成
2 期
Efficacy Study in Allergic Rhinitis Patients After Intranasal Administration of AZD8848Allergic RhinitisNCT01185080AstraZeneca93
已完成
2 期
A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety SymptomsMajor Depressive DisorderNCT01582815Janssen Research & Development, LLC121
终止
1 期
A Clinical Study of 162 in Subjects With Chronic Hepatitis B Virus InfectionChronic Hepatitis B Virus InfectionNCT06159062Yangshengtang Co., Ltd1
已完成
1 期
Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative ColitisUlcerative ColitisNCT01759056Avaxia Biologics, Incorporated33