NCT07313761已完成1 期
A Phase 1, Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations 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
- 已完成
- 发起方
- Amgen
- 入组人数
- 349
- 试验地点
- 4
- 主要终点
- AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
研究概览
简要总结
The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations 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, of any race, between 18 and 60 years of age, inclusive.
- •a. Females must not be pregnant or lactating.
- •Body mass index between 25.0 and <40.0 kg/m^
- •Have a stable body weight (<5 kg self-reported change) within 3 months before screening, as assessed by the investigator (or designee) based on participant self-report.
排除标准
- •History or evidence, at screening or check-in, 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 trial evaluation, procedures, or completion. Participants with clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) as assessed by the investigator (or designee) will be excluded.
- •History of or active diabetes (regardless of type, with the exception of a history of gestational diabetes) or hemoglobin A1C ≥6.5% (≥48 mmol/mol).
- •History or evidence of endocrine disorder (eg, Cushing's Syndrome) that can cause obesity.
- •History of acute or chronic pancreatitis within 1 year prior to check-in, or elevation in serum lipase/amylase (>2 x the upper limit of normal) at screening or a fasting serum triglyceride level of >500 mg/dL at screening.
- •Malignancy, except nonmelanoma skin cancers or cervical or breast ductal carcinoma in situ, within the last 5 years.
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type
- •History or current signs or symptoms of cardiovascular disease (aside from controlled hypertension and controlled dyslipidemia), including but not limited to myocardial infarction, congenital heart disease, valvular heart disease, coronary revascularization, or angina.
- •History or evidence of clinically significant arrhythmia at screening, including any clinically significant findings on the ECG taken at screening or check-in.
- •History of hypersensitivity, intolerance, or allergy to AMG 133 or related/similar compounds or their ingredients.
- •Estimated glomerular filtration rate ≤60 mL/min/1.73 m^2, as calculated by the Chronic Kidney Disease Epidemiology (CKD EPI) equation 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, or gastric inhibitory polypeptide receptor (GIPR) agonist or antagonist within the past 3 months prior to check-in.
- •Current or prior use of all herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the participant within the 30 days prior to enrollment, unless deemed acceptable by the investigator (or designee) and in consultation with the medical monitor, as appropriate.
- •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 trial or any other trial investigating AMG 133 or have previously received the investigational product.
研究组 & 干预措施
Maridebart Cafraglutide SC Presentation 2
Active Comparator
Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 2.
干预措施: Maridebart Cafraglutide (Drug)
Maridebart Cafraglutide SC Presentation 1
Experimental
Participants will receive a single dose of maridebart cafraglutide administered using SC presentation 1.
干预措施: Maridebart Cafraglutide (Drug)
结局指标
主要结局
AUC From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of AMG 133
时间窗: Up to Day 120
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) of AMG 133
时间窗: Up to Day 120
Maximum Observed Plasma Concentration (Cmax) of AMG 133
时间窗: Up to Day 120
次要结局
- Number of Participants with Positive Anti-AMG 133 Antibodies(Up to Day 120)
- Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)(Day 1 to Day 120)
- Number of Participants who Experienced Serious AEs (SAEs)(Screening to Day 120 (up to 148 days))
研究者
研究点 (4)
Loading locations...
相似试验
招募中
1 期
A First-in-human Trial of GRT7041 in Healthy ParticipantsTreatment of PainNCT07289776Grünenthal GmbH70
招募中
1 期
A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid TumorSolid TumorNCT07275242Suzhou Suncadia Biopharmaceuticals Co., Ltd.107
已完成
1 期
Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.5/10/1000mg in Healthy VolunteersType 2 DiabetesNCT07304700Chong Kun Dang Pharmaceutical30
已完成
1 期
Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.25/12.5/1000mg in Healthy VolunteersType 2 DiabetesNCT07304726Chong Kun Dang Pharmaceutical30
已完成
1 期
Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.5/25/1000mg in Healthy VolunteersType 2 DiabetesNCT07304687Chong Kun Dang Pharmaceutical31