A Randomised, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 Administered in Subjects With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events (TEAEs)
研究概览
简要总结
The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo within each cohort where the observational period is 18 weeks for Part 1 and 28 weeks for Part 2. All subjects will be dosed for 13 weeks in Part 1 and for 28 weeks in Part 2 with ascending weekly doses of ZP7570 at dose levels with corresponding volume of placebo.
详细描述
ZP7570 is a dual GLP-1R/GLP-2R agonist in clinical development for weight management. The overall purpose of this trial is to evaluate the safety and tolerability when applying dose titration of ascending doses of ZP7570 and at steady state.
The trial is a Phase 1, single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial including three cohorts in Part 1 in a semi-parallel design and one cohort in Part 2 in overweight and obese but otherwise healthy subjects, randomised to ZP7570 or placebo. All subjects will be dosed with ascending weekly doses of ZP7570 with corresponding volume of placebo. After informed consent has been obtained, eligibility of the subjects will be assessed during a screening Visit (V1). Additional tests to assess safety and PK and PD will take place during in-house visits and ambulatory visits.
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
- Double (Participant, Investigator)
盲法说明
Unblinding for Part 1 will be performed after completion of Part 1 (cohort 1-3) of the trial. Everyone involved in the conduct of Part 2 of the trial will be blinded until completion of Part 2 (cohort 4) of the trial and the final data review.
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
- •Age between 18 and 64 years, both inclusive.
- •Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive.
- •In overall good health according to age (medical history, physical and neurological examination, vital signs, and laboratory assessments), as judged by the investigator at screening.
排除标准
- •History of gastrointestinal (GI) diseases including functional complaints that could interfere with the pharmacokinetics of the IMP or auxiliary medicinal product (acetaminophen) of the trial.
- •Any relevant abnormal renal parameters in the following ranges:
- •Serum creatinine above UNL+10% or normalised estimated glomerular filtration rate (eGFR) below 60.0 l/min/1.73m2, as defined by CKD-EPI.
研究组 & 干预措施
ZP7570
ZP7570 for subcutaneous once-weekly injection.
干预措施: ZP7570 (Drug)
Placebo
Placebo for subcutaneous once-weekly injection. Corresponding volume matching active treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAEs)
时间窗: Day 1 to Day 127 in Part 1. Day 1 to Day 232 in Part 2
Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 127) in Part 1. Incidence of treatment emergent adverse events (TEAEs) from first dose (Day 1) to end of trial (Day 232) in Part 2.
次要结局
- Pharmacokinetics endpoints related to ZP7570 exposure(Trough concentration measured from baseline baseline (Day 1) to 18 weeks (Day 127) in Part 1 and to 33 weeks (Day 232) in Part 2.)
- Absolute change in body weight(Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.)
- Percent change in body weight(Day 1 and Day 92 in Part 1. Day 1 and Day 197 in Part 2.)