A Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
2026年8月12日 更新者：Zealand Pharma
A First-in-human, Randomized, Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are:
- Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590?
- How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body?
In the first Part of the study:
Participants will:
• Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
In the second Part of the study:
Participants will:
• Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
研究概览
地位
招聘中
详细说明
The main objective of this randomized, double-blind, placebo-controlled trial is to assess the safety and tolerability of drug ZP6590 as single ascending doses and multiple ascending doses in healthy participants living with normal weight, overweight and obesity.
In addition, the study will investigate the pharmacokinetics of the drug ZP6590.
The trial is divided in two parts:
SAD-Part 1: Participants will be administered a single subcutaneous dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
MAD-Part 2: Participants will be administered multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
After informed consent has been obtained, eligibility of the participants will be assessed during a screening visit.
SAD- and MAD-Part: Eligible participants will be admitted to the site in the morning on Day before dosing and will have ambulatory visits or remain under in-house conditions after dosing.
Safety evaluation for dose escalation:
The safety and exposure assessments of each cohort will take place before dose escalation to the next dose level will start.
研究类型
介入性
注册 (估计的)
88
阶段
- 第一阶段早期
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
- 姓名：Regulatory Affairs Department Regulatory Affairs Department, MDRA
- 电话号码：+49213140180
- 邮箱：clinicaltrialservices@profil.com
研究联系人备份
- 姓名：Regulatory Affairs Department Regulatory Affairs Department
- 电话号码：+49213140180
- 邮箱：clinicaltrialservices@profil.com
学习地点
-
-
North Rhine-Westphalia
-
Neuss、North Rhine-Westphalia、德国、41460
- 招聘中
- Profil, Institut für Stoffwechselforschung GmbH
-
接触：
- Regulatory Affairs Department Regulatory Affairs Department
- 电话号码：+49213140180
- 邮箱：clinicaltrialservices@profil.com
-
接触：
- Project Management Project Management
- 电话号码：+49213140180
- 邮箱：clinicaltrialservices@profil.com
-
首席研究员：
- Ulrike Hövelmann, MD
-
-
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:
SAD-Part:
- Male participant
- Age between 18 and 55 years, both inclusive
- Body Mass Index (BMI) between 20.0 and 29.9 kg/m^2, both inclusive
MAD-Part:
- Male participant
- Age between 18 and 60 years, both inclusive
- Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive
Exclusion Criteria:
SAD-Part and MAD-Part:
- Any clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator
- Treatment for weight management within 3 months before randomization in this trial
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：顺序分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Drug: ZP6590, solution for injection
ZP6590 will be administered as single dose administration and as multiple dose administrations.
|
Participants will receive single or multiple subcutaneous dose administrations of ZP6590.
|
|
安慰剂比较：Placebo, solution for injections
Placebo will be administered as single dose administration and as multiple dose administrations.
|
Participants will receive single or multiple subcutaneous dose administrations of Placebo.
|
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 |
|---|---|---|
|
Safety and Tolerability
大体时间：Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120
|
Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial
|
Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
大体时间：SAD-Part: From Day 1 to Day 29
|
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
大体时间：SAD Part: From Day 1 to Day 29
|
Area under the plasma concentration versus time curve from 0 to last (AUClast)
|
SAD Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
大体时间：SAD-Part: From Day 1 to Day 29
|
Peak Plasma Concentration (Cmax)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
大体时间：SAD-Part: From Day 1 to Day 29
|
Time to Peak Plasma Concentration (Tmax)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
大体时间：SAD-Part: From Day 1 to Day 29
|
Terminal rate constant (λz)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
大体时间：SAD-Part: From Day 1 to Day 29
|
Terminal half-life (t½)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
大体时间：SAD-Part: From Day 1 to Day 29
|
Apparent volume of distribution during terminal phase (Vz/f)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection
大体时间：SAD-Part: From Day 1 to Day 29
|
apparent total clearance of ZP6590 from plasma for SAD cohorts (CL/f)
|
SAD-Part: From Day 1 to Day 29
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.
|
Area under the plasma concentration versus time curve from 0 to trough (AUCτ)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
Peak Plasma Concentration (Cmax)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
Time to Peak Plasma Concentration (Tmax)
|
MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)
|
Trough concentration measured predose for MAD cohorts (Cτ)
|
MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort)
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
|
Area under the plasma concentration versus time curve from 0 to infinity (AUCinf)
|
MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Area under the plasma concentration versus time curve from 0 to last (AUClast)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Peak Plasma Concentration (Cmax)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Time to Peak Plasma Concentration (Tmax)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Terminal rate constant (λz)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Terminal half-life (t½)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Apparent volume of distribution during terminal phase (Vz/f)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Apparent total clearance of ZP6590 from plasma at steady state (SS) for MAD-cohorts (CLss/f)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
|
To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections
大体时间：MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
Mean residence time of plasma ZP6590 concentration at steady state (SS) for MAD cohorts (MRTss)
|
MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses
|
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
- 首席研究员：Ulrike Hövelmann、Profil Institut für Stoffwechselforschung GmbH
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7月9日
初级完成 (估计的)
2027年9月6日
研究完成 (估计的)
2027年9月6日
研究注册日期
首次提交
2026年7月16日
首先提交符合 QC 标准的
2026年7月22日
首次发布 (实际的)
2026年7月23日
研究记录更新
最后更新发布 (实际的)
2026年8月13日
上次提交的符合 QC 标准的更新
2026年8月12日
最后验证
2026年8月1日
更多信息
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.