此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DM

2026年6月17日 更新者:Novo Nordisk A/S

A Phase 1,Double-blinded,Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of NNC1679-0001 When Administered to Healthy Participants and Participants With T2DM

This study is testing a new medicine that might help treat people with type 2 diabetes. The purpose of the study is to see if the new study medicine is safe and how well is tolerated by the body. There will be two groups of participants in this study: healthy participants and participants with type 2 diabetes. Participant will either get study medicine (NNC1679-0001) or placebo (a treatment that has no active medicine in it). NNC1679-0001 is a new experimental medicine that doctors cannot prescribe yet. Which treatment the participant gets is decided by chance. Participant will get one dose which will be injected into the area around abdomen (belly) by the medical staff.

研究概览

研究类型

介入性

注册 (估计的)

58

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Graz、奥地利、8010
        • 招聘中
        • Medical University of Graz

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

All participants

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study.
  • Male or female (sex at birth) of nonchildbearing potential.
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.

Healthy participants

  • Body mass index (BMI) 18.5-29.9 kilograms per square meter (kg/m^2) (both inclusive) at screening.
  • Glycated haemoglobin (HbA1c) lesser than or equal to (<=) 6.4 percent (%) (47 [millimoles per mole] mmol/mol) at screening.
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Participants with Type 2 Diabetes Mellitus (T2DM)

  • BMI 20.0-34.9 kg/m^2 (both inclusive) at screening.
  • HbA1c 6.5-9.0% (47.5-74.9 mmol/mol) at screening.
  • Diagnosed with T2DM greater than or equal to (>=)180 days before screening.
  • Stable (as judged by the investigator) daily dose(s) of metformin or combination of metformin and dipeptidyl peptidase IV (DPP-4) inhibitors and/or sodium-glucose co-transport 2 SGLT 2) inhibitors >= 90 days before screening.

Exclusion Criteria:

All participants

  • Screening alanine aminotransferase (ALT) values greater than (>) upper limit of normal (ULN) +10%, aspartate aminotransferase (AST) values >ULN +20%, or total bilirubin >ULN.
  • Renal impairment, defined as estimated glomerular filtration rate (eGFR) <60.0 milliliter per minute per 1.73 square meter (mL/min/1.73m^2), at screening.
  • Clinical evidence of chronic kidney disease (CKD) and/or urinary albumin: creatinine ratio (UACR) >30 milligrams per gram (mg/g).
  • Presence or history of cardiovascular disease, including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias, or clinically significant conduction disorders.

Healthy participants

  • Any disorder that, in the investigator's opinion, might jeopardise participants' safety or compliance with the protocol.
  • Supine blood pressure at screening outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.

Participants with T2DM

  • Any disorder except for mild conditions under stable treatment associated with T2DM, which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
  • Supine blood pressure at screening outside the range of 90-159 mmHg for systolic or 50-99 mmHg for diastolic. This exclusion criterion also pertains to those participants who are receiving antihypertensive treatment.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:NNC1679-0001
Participants will receive NNC1679-0001 subcutaneously.
NNC1679-0001 will be administered subcutaneously.
安慰剂比较:Placebo
Participants will receive placebo matched to NNC1679-0001 s.c.
安慰剂将皮下给药。

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of Treatment-Emergency Adverse Events (TEAEs)
大体时间:From dosing (day 1) upto week 34
Measured in events.
From dosing (day 1) upto week 34

次要结果测量

结果测量
措施说明
大体时间
Number of TEAEs
大体时间:From dosing (day 1) until V15a/V15b (week 26)
Measured in events.
From dosing (day 1) until V15a/V15b (week 26)
Number of hypoglycaemic episodes
大体时间:From dosing (day 1) upto week 34
Measured in episodes.
From dosing (day 1) upto week 34
AUC: The area under the NNC1679-0001 plasma concentration-time curve from time zero to the last measurable concentration after a single dose
大体时间:From dosing (day 1) upto day 3 or day 15
Measured in hours*nanograms per milliliter (hour × ng/mL).
From dosing (day 1) upto day 3 or day 15
Cmax: The maximum concentration of NNC1679-0001 in plasma after a single dose
大体时间:From dosing (day 1) upto day 3 or day 15
Measured in nanograms per milliliter (ng/mL).
From dosing (day 1) upto day 3 or day 15
tmax: The time from dosing to maximum plasma concentration of NNC1679-0001 after a single dose
大体时间:From dosing (day 1) upto day 3 or day 15
Measured in hours.
From dosing (day 1) upto day 3 or day 15
t1/2: Terminal half-life for NNC1679-0001 after a single dose
大体时间:From dosing (day 1) upto day 3 or day 15
Measured in hours.
From dosing (day 1) upto day 3 or day 15
CLR: Renal clearance of NNC1679-0001 after a single dose
大体时间:From dosing (day 1) upto day 3
Measured in liter per hours (L/hours).
From dosing (day 1) upto day 3

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Clinical Transparency dept. 2834、Novo Nordisk A/S

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月4日

初级完成 (估计的)

2028年6月25日

研究完成 (估计的)

2028年6月25日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月6日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • NN1679-8505
  • U1111-1329-6912 (其他标识符:World Health Organization (WHO))
  • 2025-523304-68 (其他标识符:European Medical Agency (EMA))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅