A Three-part First-in-human, Single and Multiple Ascending and Repeated Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous GUB-UCN2 in Healthy Lean and Obese Participants and in Participants With Type 2 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Gubra A/S
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Number of Treatment Emergent Adverse Events
研究概览
简要总结
The trial will enroll healthy volunteers and individuals living with obesity, with and without Type 2 Diabetes. The study, with a treatment period of up to 16 weeks in selected cohorts, will investigate GUB-UCN2 as both a standalone therapy and on top of standard of care for obesity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent obtained before any trial-related activities
- •Males and female participants, aged between 18-55 years
- •Body Mass Index (BMI) between 20.0 and 29.9 kg/m^2, inclusive
- •Considered generally healthy upon completion of medical history and screening safety assessments
- •Signed and dated informed consent obtained before any trial-related activities
- •Male participants, aged between 18-55 years
- •Body Mass Index (BMI) between 30.0 and 35.0 kg/m^2, inclusive
- •Part 3 (participants with obesity)
- •Signed and dated informed consent obtained before any trial-related activities
- •Males and female participants, aged between 18-75 years
- •Body Mass Index (BMI) between 30.0 and 45.0 kg/m^2
- •Part 3 (participants with T2D)
- •Signed and dated informed consent obtained before any trial-related activities
- •Male and female participants, aged between 18-75 years
- •Body Mass Index (BMI) between 27.0 and 35.0 kg/m^2
- •Diagnosed with type 2 diabetes mellitus, HbA1c ≤ 69.0 mmol/mol (≤ 8.5%)
- •Stable daily dose of antidiabetic medication
排除标准
- •Known history of serious adverse reactions or serious hypersensitivity to drug or formulation excipients
- •Presence or history of clinically significant gastrointestinal, cardiovascular, renal, hepatic, dermatological, respiratory, neurological, psychiatric, malignant, metabolic, endocrinological, hematologic or venereal disorder
- •Use or planned use of concomitant medication impacting the assessment of trial endpoints
- •Clinically significant abnormal laboratory parameters
- •Women of childbearing potential who are not using highly effective contraception
研究组 & 干预措施
Part 3
GUB-UCN2 will be investigated as monotherapy and on top of standard of care obesity treatment against placebo
干预措施: GUB-UCN2 (Drug)
Part 3
GUB-UCN2 will be investigated as monotherapy and on top of standard of care obesity treatment against placebo
干预措施: Placebo (Drug)
Part 1
Participants will be randomized to investigational drug or placebo
干预措施: GUB-UCN2 (Drug)
Part 1
Participants will be randomized to investigational drug or placebo
干预措施: Placebo (Drug)
Part 2
Participants will be randomized to investigational drug or placebo
干预措施: GUB-UCN2 (Drug)
Part 2
Participants will be randomized to investigational drug or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events
时间窗: From baseline up to week 22
次要结局
- AUC(0-∞),SD(From baseline up to week 6)
- AUC(0-last),SD(From baseline up to week 6)
- tmax,SD(From baseline up to week 6)
- Cmax,SD(From baseline up to week 6)
- AUCτ,SS(From baseline up to week 22)
- Cmax, SS(From baseline up to week 22)
- tmax, SS(From baseline up to week 22)