NCT07429032已完成1 期
A Phase 1, Randomized, Double Blind, Multiple Dose, Placebo-controlled, Parallel Group Study to Evaluate the Impact of AMG 133 on Gastric Emptying in Participants Living With Overweight or Obesity
Amgen1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2025年4月17日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) for Acetaminophen
研究概览
简要总结
The primary objective of the trial is to evaluate the effect of AMG 133 versus placebo on acetaminophen pharmacokinetics (PK), a marker for gastric emptying, 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
- Double (Participant, Investigator)
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
- •Male or female participants between 18 and 65 years of age.
- •a. Females must not be pregnant or lactating.
- •Body mass index between ≥ 27 to < 40 kg/m^2.
排除标准
- •History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- •History of or active diabetes or Hemoglobin A1C ≥ 6.5% (≥ 48 mmol/mol).
- •History or evidence of endocrine disorder.
- •History of acute or chronic pancreatitis within 1 year, or elevation in serum lipase/amylase (> 2 x the upper limit of normal [ULN]), or fasting serum triglyceride level of > 500 mg/dL.
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type
- •Uncontrolled thyroid disease.
- •History of or current signs of gastroparesis.
- •History or current signs or symptoms of cardiovascular disease.
- •History suggestive of esophageal, gastric, or duodenal ulceration or bowel disease; or a history of gastrointestinal surgery other than uncomplicated appendectomy or hernia repair.
- •History of gastrointestinal tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, gastric/jejunal tube feeds, or uncontrolled inflammatory gastrointestinal disease.
- •History of hypersensitivity, intolerance, or allergy to AMG 133 or related/similar compounds or acetaminophen or their ingredients.
- •Any contraindication to acetaminophen according to the applicable labelling.
- •Inability to swallow oral medication.
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x the upper limit of normal.
- •Use of any over-the-counter or prescription medications within 30 days or 5 half-lives.
- •Current use or prior use of any glucagon-like peptide 1 receptor (GLP-1R) agonist, or glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months.
- •Current or prior use of all herbal medicines (e.g., St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment.
- •Participant has received a dose of an investigational medicinal product (IMP) within the past 30 days or 5 half-lives.
- •Have previously completed or withdrawn from this study or any other study investigating AMG 133 or have previously received the IMP.
- •Current use of acute or chronic medication known to affect gastric emptying.
研究组 & 干预措施
AMG 133
Experimental
Participants will receive AMG 133 subcutaneously (SC) and acetaminophen orally.
干预措施: AMG 133 (Drug)
AMG 133
Experimental
Participants will receive AMG 133 subcutaneously (SC) and acetaminophen orally.
干预措施: Acetaminophen (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC and acetaminophen orally.
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC and acetaminophen orally.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) for Acetaminophen
时间窗: Days 1, 3, 8, 17, 31, 59, 64, and 86
Time to Cmax (Tmax) for Acetaminophen
时间窗: Days 1, 3, 8, 17, 31, 59, 64, and 86
Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) for Acetaminophen
时间窗: Days 1, 3, 8, 17, 31, 59, 64, and 86
AUC from Time Zero to Infinity (AUCinf) for Acetaminophen
时间窗: Days 1, 3, 8, 17, 31, 59, 64, and 86
AUC from Time Zero to 5 Hours (AUC5hr) for Acetaminophen
时间窗: Days 1, 3, 8, 17, 31, 59, 64, and 86
次要结局
- Cmax for AMG 133(Days 1 to 9, 15 to 18, 22, 29 to 32, 36, 44, 57 to 65, 72, 85 to 87, 100, and 128)
- AUClast for AMG 133(Days 1 to 9, 15 to 18, 22, 29 to 32, 36, 44, 57 to 65, 72, 85 to 87, 100, and 128)
- AUCinf for AMG 133(Days 1 to 9, 15 to 18, 22, 29 to 32, 36, 44, 57 to 65, 72, 85 to 87, 100, and 128)
- Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)(Day 1 to Day 128)
- Number of Participants Who Experience Serious Adverse Events (SAEs)(Screening (Day -28) to Day 128)
- Change from Baseline in Food Intake and Appetite(Baseline to Day 64)
- Number of Participants Who Develop Anti-AMG 133 Antibodies(Day 2 up to Day 128)
研究者
研究点 (1)
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