NCT07570992招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Number of Treatment-Emergency Adverse Events (TEAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
NNC1679-0001
Experimental
Participants will receive NNC1679-0001 subcutaneously.
干预措施: NNC1679-0001 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matched to NNC1679-0001 s.c.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Treatment-Emergency Adverse Events (TEAEs)
时间窗: From dosing (day 1) upto week 34
Measured in events.
次要结局
- Number of TEAEs(From dosing (day 1) until V15a/V15b (week 26))
- Number of hypoglycaemic events(From dosing (day 1) upto week 34)
- AUC: The area under the NNC1679-0001 plasma concentration-time curve(From dosing (day 1) upto day 3)
- Cmax: The maximum concentration of NNC1679-0001 in plasma(From dosing (day 1) upto day 3)
- tmax: The time from dosing to maximum plasma concentration of NNC1679-0001(From dosing (day 1) upto day 3)
- t1/2: Terminal half-life for NNC1679-0001 after dosing(From dosing (day 1) upto day 3)
- CLR: Renal clearance of NNC1679-0001(From dosing (day 1) upto day 3)
- Number of hypoglycaemic 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(From dosing (day 1) upto day 3 or day 15)
- Cmax: The maximum concentration of NNC1679-0001 in plasma after a single dose(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(From dosing (day 1) upto day 3 or day 15)
- t1/2: Terminal half-life for NNC1679-0001 after a single dose(From dosing (day 1) upto day 3 or day 15)
- CLR: Renal clearance of NNC1679-0001 after a single dose(From dosing (day 1) upto day 3)
研究者
研究点 (1)
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