A Prospective, Multicenter, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The rate of treatment-associated adverse events (AEs)
研究概览
简要总结
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an approved and well-established therapy for type 2 diabetes mellitus (T2DM), providing both robust glycemic control and weight reduction. Semaglutide Depot, is a long-acting formulation of semaglutide, designed for once every four weeks administration, intended to reduce treatment burden, and improve adherence supporting sustained glycemic control over time.
This Phase I/Ila dose escalation study design to evaluate the safety, tolerability, pharmacokinetics and efficacy of Semaglutide Depot in adults with T2DM.
详细描述
Study Title:
A Prospective, Multicenter, Open-Label, Dose Escalation Phase I/Ila Study to Assess the Safety, Tolerability, and Efficacy of Semaglutide Depot in Subjects with Type 2 Diabetes Mellitus
Background:
Type 2 diabetes mellitus (T2DM) is a chronic condition in which the body cannot properly use insulin, leading to elevated blood glucose levels. It is often associated with overweight or obesity and can lead to serious complications if not well controlled.
Semaglutide, is a GLP 1 receptor agonist, that helps lower blood glucose by increasing insulin secretion, reducing glucagon (a hormone that raises blood glucose), slowing gastric emptying, and reducing appetite. In addition to improving glycemic control, it also supports weight loss and has demonstrated cardiovascular benefits. Semaglutide is already approved in several formulations (examples: Ozempic® for type 2 diabetes and Wegovy® for weight management), but these require once-weekly injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-64 years with T2DM, BMI 25-35 kg/m2
- •On stable Semaglutide 1 mg weekly and for at least 3 months
- •HbA1c <8%, eGFR≥60 ml/minute
- •For women: either non-childbearing potential or agreement to use acceptable contraception
排除标准
- •Participation in another investigational drug clinical study within 3 months
- •History of cardiovascular or cerebrovascular disease
- •Neuropathy or retinopathy or macular edema necessitating medical treatment
- •Type 1 diabetes
- •Unstable weight (> 5% change in the last 3 months)
- •Current use of insulin and /or sulfonylureas and/or glinides
- •Known contraindications to Semaglutide (per FDA-approved Semaglutide label)
- •Recent immunosuppressive therapy (within 90 days) or chemotherapy for malignancy within 5 years
- •Moderate or severe hepatic impairment, (ALT or AST> 2 x upper limit of normal (ULN)
- •Severe hypertriglyceridemia (triglycerides >500 mg/dl)
- •Pregnant or breast feeding
- •Any condition that may increase risk or interfere with study participation (per Investigator judgement)
研究组 & 干预措施
Cohort 1 - SG Depot 2 mg
干预措施: SG Depot 2 mg (Drug)
Cohort 3 - SG Depot 6 mg
干预措施: SG Depot 6 mg (Drug)
Cohort 4 - SG Depot 8 mg
干预措施: SG Depot 8 mg (Drug)
Cohort 2 - SG Depot 4 mg
干预措施: SG Depot 4 mg (Drug)
结局指标
主要结局
The rate of treatment-associated adverse events (AEs)
时间窗: Through study completion, up to 28 weeks for each subject
Plasma concentration of semaglutide
时间窗: Through study completion, up to 28 weeks for each subject
次要结局
- Change in HbA1c(Baseline (week 0), week 12)
- Change in fasting plasma glucose from baseline(Baseline (week 0), week 12)
- Change in body weight from baseline(Baseline (week 0), week 12)
- The maximal tolerated dose (MTD) of SG Depot(Through study completion, up to 28 weeks for each subject)