NCT07717814已完成1 期
A Phase 1, Randomized, Open-label, Single-dose, Parallel Group Study to Assess the Relative Bioavailability of AMG 133 Administered Using One of Three Drug Products in Participants Living With Overweight or Obesity
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 154
- 试验地点
- 4
- 主要终点
- Maximum Observed Concentration (Cmax) of AMG 133
研究概览
简要总结
The primary objective of the trial is to evaluate the pharmacokinetics (PK) of AMG 133 administered as a single subcutaneous (SC) dose using a liquid drug product in vial compared to a frozen liquid drug product in vial in participants living with overweight or obesity.
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
- 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
- 是
入选标准
- •Provide signed and dated informed consent before any study procedures.
- •Be male or female, 18 to 65 years old, at screening.
- •May have well-controlled conditions such as obstructive sleep apnea, high blood pressure, high cholesterol, or hypothyroidism on stable treatment for ≥ 3 months. Other mild, stable health conditions may be allowed with investigator and medical monitor approval.
- •Body mass index (BMI) between 25 and 40 kg/m² at screening.
- •Stable body weight (less than 5 kg change by self-report) during the 3 months before screening.
- •No major changes in diet or lifestyle (such as new weight-loss or exercise programs) during the past 3 months.
排除标准
- •Any significant medical condition or abnormal test result that could increase risk or interfere with study participation, based on investigator judgment.
- •Diabetes (any type except past gestational diabetes) or Hemoglobin A1c (HbA1c) ≥ 6.5%.
- •Endocrine disorders that can cause obesity (for example, Cushing's syndrome).
- •Pancreatitis within the past year, or abnormal pancreatic blood tests (lipase/amylase > 2 × normal) or fasting triglycerides > 500 mg/dL.
- •Cancer within 5 years (except treated non-melanoma skin cancer or in-situ cervical/breast lesions).
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type
- •Uncontrolled thyroid disease (thyroid stimulating hormone [TSH] > 6.0 or < 0.4 mIU/L). Participants on stable thyroid-replacement therapy for ≥ 3 months may be included if TSH is in range.
- •History or current signs of gastroparesis (delayed stomach emptying).
- •Weight-loss surgery within 6 months before check-in.
- •Heart or blood-vessel disease (aside from controlled high blood pressure or cholesterol), such as heart attack, angina, valve disease, or prior bypass/stent.
- •Clinically significant abnormal heart rhythm on electrocardiogram (ECG) at screening or check-in.
- •QT corrected for heart rate using Fridericia's method (QTcF) > 450 ms (males) or > 470 ms (females), or a history of long QT syndrome.
- •Second- or third-degree heart block.
- •Blood pressure > 150/95 mmHg or < 90/50 mmHg, or pulse > 110 bpm. A single repeat is allowed if values normalize.
- •Allergy or hypersensitivity to AMG 133 or its ingredients.
- •Poor veins for blood draws.
- •Kidney function (estimated glomerular filtration rate [eGFR]) ≤ 60 mL/min/1.73 m^
- •Liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) > 2X normal.
- •Positive test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) (exceptions apply for prior vaccination or resolved hepatitis B virus [HBV] infection).
- •Current or recent (within 6 months) suicidal thoughts, suicide attempts, or major psychiatric illness, including depression.
- •Use of any prescription or over-the-counter medicines within 30 days or 5 half-lives (whichever is longer) before check-in, except:
- •Acetaminophen ≤ 2 g/day for pain
- •Hormone replacement (e.g., estrogen, thyroid) or hormonal contraception
- •Stable treatments (≥ 3 months) for high blood pressure, high cholesterol, or other mild, well-controlled conditions approved by the investigator and medical monitor.
- •Use of any glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP) receptor agonist/antagonist within 3 months.
- •Use of herbal medicines, vitamins, or supplements within 30 days, unless approved by the investigator and sponsor.
- •Consumption of poppy-seed-containing foods within 7 days before check-in.
- •Alcohol abuse or regular intake > 21 units/week (men) or > 14 units/week (women), or drug abuse within 1 year. (1 unit = 12 oz beer, 1.5 oz liquor, 5 oz wine.)
- •Alcohol use within 48 hours before check-in, or unwillingness to limit alcohol to ≤ 1 unit/day from discharge through study end.
- •Strenuous exercise or a new exercise program within 7 days before check-in.
- •Positive drug screen or tetrahydrocannabinol (THC) test, or unwillingness to avoid illicit drugs/THC through end of study.
- •Positive pregnancy test at screening or check-in.
- •Breastfeeding, or planning to breastfeed within 16 weeks after receiving AMG
- •Men and women unwilling to use required contraception through 16 weeks after receiving AMG
- •Men unwilling to abstain from sperm donation or women unwilling to abstain from egg donation through 16 weeks after receiving AMG
- •Men with female partners of childbearing potential unwilling to inform their partner and adhere to contraception requirements.
- •Men with pregnant partners (or partners planning pregnancy) unwilling to use effective contraception or abstain from intercourse through 16 weeks after receiving AMG
- •Participation in another investigational drug study within 30 days or 5 half-lives (whichever is longer).
- •Previous participation in any study of AMG
- •Blood donation within 3 months, plasma within 2 weeks, or platelets within 6 weeks before check-in.
- •Unwillingness to follow study requirements or restrictions.
- •Any other reason, in the investigator's opinion, that makes participation unsuitable.
结局指标
主要结局
Maximum Observed Concentration (Cmax) of AMG 133
时间窗: Up to Day 120
Area Under the Concentration-time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
时间窗: Up to Day 120
AUC From Time 0 Extrapolated to Infinity (AUCinf) of AMG 133
时间窗: Up to Day 120
次要结局
- Number of Participants who Experienced Serious AEs (SAEs)(Screening to Day 120 (up to 148 days))
- Number of Participants with Positive Anti-AMG 133 Antibody Formation(Up to Day 120)
- Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)(Day 1 to Day 120)
研究者
研究点 (4)
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