NL-OMON55332已完成不适用
Investigation of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of NNC0480-0389 in combination with semaglutide s.c. - SAD and MAD of NNC0480-0389 in combination with semaglutide
ovo Nordisk0 个研究点目标入组 156 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Male aged 18-45 years (both inclusive) at the time of signing informed
- •- BMI between 20.0 kg/m2 and 29.9 kg/m2 (both inclusive).
- •MAD part (not applicable for PoC cohort)
- •- BMI between 20.0 kg/m2 and 29.9 kg/m2 (both inclusive).
- •- Female of non-childbearing potential or male aged 18-55 years (both
- •inclusive) at the time of signing informed consent.
- •MAD part (only applicable for PoC cohort)
- •- BMI between 25.0 kg/m2 and 39.9 kg/m2 (both inclusive). Overweight or obesity
- •should be due to excess adipose tissue, as judged by the investigator.
- •-Female of non-childbearing potential or male aged 18-64 years (both inclusive)
- •at the time of signing informed consent.
- •-Subjects treated with diet and exercise as monotherapy or in combination with
- •1-2 of the following anti-diabetic drug(s) at a stable dose for at least 30
- •days prior to screening: metformin, sulfonylureas, meglitinides, DPP-4
- •inhibitors, alpha-glucosidase inhibitors,
- •thiazolidinediones, GLP-1 receptor agonists or SLGT-2 inhibitors. The metformin
- •dose should be >= 1500 mg to <= 3000 mg or maximum tolerated or effective dose
- •documented in subject's medical record.
排除标准
- •- Any disorder (except for conditions associated with T2D for the PoC cohort
- •included in the MAD part) which in the investigator*s opinion might jeopardise
- •subject*s safety or compliance with the protocol.
- •- HbA1c >= 6.5 % (48 mmol/mol) at screening (except for MAD part only applicable
- •for PoC cohort).
- •- Use of prescription medicinal products or non-prescription drugs, except
- •routine vitamins,
- •occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical
- •medication not
- •reaching systemic circulation within 14 days prior to the day of screening
- •(except for the MAD part only applicable for PoC cohort).
研究者
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