NCT07832799尚未招募1 期
A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Maridebart Cafraglutide (AMG 133) Drug Products in Participants Living With Overweight or Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Amgen
- 入组人数
- 340
- 主要终点
- Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide
研究概览
简要总结
The primary objective of this trial is to evaluate the pharmacokinetics (PK) of two maridebart cafraglutide drug products 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants, of any race, between 18 and 60 years of age (inclusive).
- •Females must not be pregnant or lactating.
- •Body mass index of ≥ 25.0 to < 40.0 kilograms per square meter (kg/m^2).
- •Have a stable body weight within 3 months before screening.
排除标准
- •History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
- •History of or active diabetes (regardless of type, except history of gestational diabetes), or hemoglobin A1c ≥ 6.5%.
- •History or evidence of endocrine disorder that can cause obesity.
- •History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase or amylase (> 2 x upper limit of normal [ULN]) at screening or check-in, or fasting serum triglyceride level of > 500 milligrams per deciliter (mg/dL) at screening.
- •Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ treated with curative intent, within the last 5 years.
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type
- •History or current signs or symptoms of cardiovascular disease.
- •History of hypersensitivity, intolerance, or allergy to maridebart cafraglutide or related/similar compounds or its ingredients.
- •Estimated glomerular filtration rate ≤ 60 mL/min/1.73 m^2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (2021) at screening or check-in.
- •Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer) before check-in.
- •Current use or prior use of any glucagon-like peptide-1 receptor (GLP-1R) agonist, glucose-dependent insulinotropic polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in.
- •Current or prior use of all herbal medicines, vitamins, and supplements consumed by the participant within the 30 days prior to check-in.
- •Participant has received a dose of an investigational drug within the past 30 days or 5 half-lives, whichever is longer, prior to check-in.
- •Have previously completed or withdrawn from this study or any other study investigating maridebart cafraglutide or have previously received maridebart cafraglutide.
研究组 & 干预措施
Maridebart Cafraglutide (Test)
Experimental
Participants will receive maridebart cafraglutide (test formulation) via subcutaneous (SC) injection.
干预措施: Maridebart Cafraglutide (Drug)
Maridebart Cafraglutide (Reference)
Active Comparator
Participants will receive maridebart cafraglutide (reference formulation) via SC injection.
干预措施: Maridebart Cafraglutide (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Maridebart Cafraglutide
时间窗: Up to Day 120
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration of Maridebart Cafraglutide
时间窗: Up to Day 120
Maximum Observed Concentration (Cmax) of Maridebart Cafraglutide
时间窗: Up to Day 120
次要结局
- Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events(Up to Day 120)
- Number of Participants With Anti-Maridebart Cafraglutide Antibodies(Up to Day 120)
研究者
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