A Phase 1, Open-Label, Single and Multiple Dose Study to Investigate the Safety, Tolerability, and Relative Bioavailability of Single and Multiple Weekly Subcutaneous Doses of Eloralintide, and Single and Multiple Weekly Subcutaneous Doses of Eloralintide With Tirzepatide in Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 3
- 主要终点
- Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide
研究概览
简要总结
The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it.
There will be 6 cohorts. The study will last up to approximately 26 weeks, excluding screening for Cohorts A and B, 11 weeks for Cohorts C and D, and 12 weeks for Cohorts E and F.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Participants with a history of thyroid disease or on thyroid medication will need to be biochemically euthyroid as assessed by measuring thyroid stimulating hormone at screening
- •Have a body mass index (BMI) within the range of 27.0 to 40.0 kilogram per square meter (kg/m²), inclusive
- •Have had a stable weight for the 3 months prior to screening, that is, less than 5% body weight change
排除标准
- •Have known allergies to related compounds of eloralintide or tirzepatide, or any of the components of the formulations
- •Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- •Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have glycated hemoglobin greater than or equal to 6.5% or 48 millimole per mole (mmol/mol)
- •Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying for example, gastric bypass surgery or pyloric stenosis
- •Have obesity induced by other endocrinologic disorders for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity for example, Melanocortin 4 Receptor deficiency or Prader Willi syndrome
- •Have a history of hypocalcemia or hypercalcemia, or abnormal laboratory values for calcium or serum phosphorus
- •Have a medical history or current evidence of clinically significant cardiac condition, as per the investigator, including:
- •second or third degree heart block
- •sick sinus syndrome
- •peripheral arterial circulatory disorders
- •valvular disease
- •cardiomyopathy, or
- •other clinically significant cardiac condition
- •Have taken approved or investigational medication for weight loss, including GLP-1 RAs, within the previous 3 months of study screening
- •Intend to use any weight loss medications during study participation
研究组 & 干预措施
Eloralintide and Tirzepatide-Cohorts A-D
Eloralintide and Tirzepatide administered subcutaneously (SC)
干预措施: Eloralintide and Tirzepatide (Drug)
Eloralintide-Cohorts E and F
Eloralintide administered SC
干预措施: Eloralintide (Drug)
结局指标
主要结局
Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide
时间窗: Day 106 Predose to Approximately Week 26
PK: AUC of Eloralintide and Tirzepatide
Cohorts A and B: PK: Maximum Concentration (Cmax) of Eloralintide and Tirzepatide
时间窗: Day 106 Predose to Approximately Week 26
PK: Cmax of Eloralintide and Tirzepatide
Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide
时间窗: Baseline Up to Approximately Week 11
PK: AUC of Eloralintide and Tirzepatide
Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide
时间窗: Baseline Up to Approximately Week 11
PK: Cmax of Eloralintide and Tirzepatide
Cohorts E and F: PK: AUC of Eloralintide
时间窗: Day 8 Predose Up to Approximately Week 12
PK: AUC of Eloralintide
Cohorts E and F: PK: Cmax of Eloralintide
时间窗: Day 8 Predose Up to Approximately Week 12
PK: Cmax of Eloralintide
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
时间窗: Baseline Up to Approximately Week 26
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
次要结局
未报告次要终点