一项关于 ABBV-295 皮下注射评估肥胖成人参与者不良事件和药代动力学的研究
一项评估ABBV-295在成人肥胖受试者中多次皮下给药的安全性、耐受性、药代动力学、免疫原性和药效学的1b期研究
This study is to assess adverse events, change in body weight and pharmacokinetics in adult participants with obesity receiving ABBV-295 subcutaneous injections or matching placebo.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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California
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Anaheim、California、美国、92801
- CenExel Act- Anaheim Clinical Trials /ID# 283200
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Illinois
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Grayslake、Illinois、美国、60030
- Acpru /Id# 278624
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- BMI ≥ 30.0 to ≤ 45.0 kg/m2 after rounding to the tenths decimal at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with or without weight related stable comorbidities (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
- A female who is not pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 60 days after the last dose of study treatment.
Exclusion Criteria:
- Participant has a self-reported change in body weight ≥ 5% within 3 months prior to Screening.
- HbA1c ≥ 6.5% and/or serum glucose ≥ 126 mg/dL at Screening.
- Participant has taken a medication for the purpose of treating obesity or has been enrolled in an obesity trial within 180 days prior to study treatment administration.
学习计划
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 |
|---|---|
|
实验性的：ABBV-295 or Placebo-Group 1
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
实验性的：ABBV-295 or Placebo-Group 2
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
实验性的：ABBV-295 or Placebo-Group 3
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
实验性的：ABBV-295 or Placebo-Group 3 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
实验性的：ABBV-295 or Placebo-Group 4
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
实验性的：ABBV-295 or Placebo-Group 4 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
实验性的：ABBV-295 or Placebo-Group 5
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
|
实验性的：ABBV-295 or Placebo-Group 6
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
Subcutaneous Injections Subcutaneous Injections |
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 Participants with Adverse Events (AEs)
大体时间：Up to approximately 194 days
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. |
Up to approximately 194 days
|
|
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
大体时间：Up to approximately 194 days
|
Number of participants with abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed. |
Up to approximately 194 days
|
|
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
大体时间：Up to approximately 194 days
|
12-lead resting ECG will be recorded. |
Up to approximately 194 days
|
|
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
大体时间：Up to approximately 194 days
|
Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed. |
Up to approximately 194 days
|
|
Maximum Observed Plasma Concentration (Cmax) of ABBV-295
大体时间：Up to approximately 194 days
|
Cmax of ABBV-295 |
Up to approximately 194 days
|
|
Time to Cmax (Tmax) of ABBV-295
大体时间：Up to approximately 194 days
|
Tmax of ABBV-295 |
Up to approximately 194 days
|
|
Trough plasma concentration (Ctrough) of ABBV-295
大体时间：Up to approximately 194 days
|
Ctrough of ABBV-295 |
Up to approximately 194 days
|
|
Apparent terminal phase elimination rate constant (BETA) of ABBV-295
大体时间：Up to approximately 194 days
|
BETA of ABBV-295 |
Up to approximately 194 days
|
|
Terminal phase elimination half-life (t1/2) of ABBV-295
大体时间：Up to approximately 194 days
|
t1/2 of ABBV-295 |
Up to approximately 194 days
|
|
Area under the plasma concentration-time curve (AUC) of ABBV-295
大体时间：Up to approximately 194 days
|
AUC of ABBV-295 |
Up to approximately 194 days
|
|
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295
大体时间：Up to approximately 194 days
|
AUCtau of ABBV-295 |
Up to approximately 194 days
|
|
Dose Normalized Cmax of ABBV-295
大体时间：Up to approximately 194 days
|
Dose normalized Cmax of ABBV-295 will be assessed. |
Up to approximately 194 days
|
|
Dose Normalized AUC of ABBV-295
大体时间：Up to approximately 194 days
|
Dose normalized AUC of ABBV-295 will be assessed. |
Up to approximately 194 days
|
|
Incidence of Anti-Drug Antibodies (ADAs)
大体时间：Up to approximately 194 days
|
Incidence of ADAs will be assessed. |
Up to approximately 194 days
|
|
Percent Change in Body Weight From Baseline
大体时间：Up to approximately 194 days
|
Percent change in body weight (kg) will be assessed. |
Up to approximately 194 days
|
合作者和调查者
赞助
调查人员
- 研究主任：ABBVIE INC.、AbbVie
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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