NCT07441252招募中2 期
Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 180
- 试验地点
- 23
- 主要终点
- Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
研究概览
简要总结
The main objective of this trial will be to determine whether maridebart cafraglutide is superior to placebo on reduction in liver fat content and body weight in participants living with obesity or overweight and elevated liver fat content, when administered in conjunction with reduced-calorie diet and increased physical activity.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Body Mass index (BMI) ≥ 27 kg/m^2 to ≤ 40 kg/m^2 at screening.
- •For participants with type 2 diabetes mellitus (T2DM) at screening:
- •HbA1c ≤ 9.5% (80 mmol/mol) at screening.
- •Treated with diet and exercise alone and/or a stable treatment with metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or combination.
- •Liver Controlled Attenuation Parameter (CAPTM) ≥ 300 dB/meter via FibroScan® assessment.
- •Liver fat content ≥ 10% by MRI as determined by the central imaging vendor at screening.
- •MRI assessment should only be performed after all other eligibility has been confirmed whenever possible.
- •History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
排除标准
- •Recent or planned surgical/device-based obesity treatment (<1 year).
- •History of malignancy within the past 5 years (exceptions apply).
- •Type 1 diabetes or non-type 2 diabetes mellitus (T2DM); unstable/severe hypoglycemia.
- •Advanced diabetic retinopathy or macular edema.
- •History of pancreatitis (acute <180 days or chronic).
- •History of medullary thyroid carcinoma (MTC) or MEN-2
- •Major cardiovascular event within 60 days (e.g., myocardial infarction [MI], stroke, coronary artery bypass graft [CABG]).
- •New York Heart Association (NYHA) Class IV heart failure.
- •Unstable psychiatric disorders within 2 years.
- •Significant liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD) (e.g., hepatitis, cirrhosis, hepatic decompensation).
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 or on dialysis.
- •Patient Health Questionnaire-9 (PHQ-9) ≥ 15, or suicidal ideation/behavior (Columbia-Suicide Severity Rating Scale [C-SSRS]).
- •Inability to undergo MRI scan (e.g., due to metal implant, claustrophobia, or body size limitations).
研究组 & 干预措施
Maridebart Cafraglutide
Experimental
Participants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks.
干预措施: Maridebart cafraglutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo as a SC injection Q4W for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
时间窗: Baseline and Week 52
Percent Change from Baseline in Body Weight at Week 52
时间窗: Baseline and Week 52
次要结局
- Number of Participants Achieving < 5% LFC by MRI at Week 52(Week 52)
- Percent Change from Baseline in Thigh Muscle Volume by MRI at Week 24 and Week 52(Baseline, Week 24, and 52)
- Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52(Baseline and Week 52)
- Change from Baseline in Waist-to-height Ratio at Week 52(Baseline and Week 52)
- Change from Baseline in Aspartate Aminotransferase (AST) at Week 52(Baseline and Week 52)
- Change from Baseline in LFC by MRI at Week 52(Baseline and Week 52)
- Number of Participants Achieving ≥ 30% Reduction from Baseline in Liver Fat Content (LFC) by MRI at Week 52(Baseline and Week 52)
- Percent Change from Baseline in LFC by MRI at Week 24(Baseline and Week 24)
- Change from Baseline in LFC by MRI at Week 24(Baseline and Week 24)
- Percent Change from Baseline in Thigh Muscle Fat Fraction by MRI at Week 24 and Week 52(Baseline, Week 24, and 52)
- Percent Change from Baseline in Thigh Intermuscular and Intramuscular Fat Volume by MRI at Week 24 and Week 52(Baseline, Week 24, and 52)
- Percent Change from Baseline in Abdominal Subcutaneous Adipose Tissue (ASAT) Volume by MRI at Week 52(Baseline and Week 52)
- Percent Change from Baseline in VAT Volume by MRI at Week 24(Baseline and Week 24)
- Percent Change from Baseline in ASAT Volume by MRI at Week 24(Baseline and Week 24)
- Change from Baseline in Waist Circumference at Week 52(Baseline and Week 52)
- Change from Baseline in Alanine Aminotransferase (ALT) at Week 52(Baseline and Week 52)
- Change from Baseline in Gamma Glutamyl Transferase (GGT) at Week 52(Baseline and Week 52)
- Change from Baseline in Hemoglobin A1c (HbA1c) at Week 52(Baseline and Week 52)
- Change from Baseline in Fasting Glucose at Week 52(Baseline and Week 52)
- Percent Change from Baseline in Fasting Insulin at Week 52(Baseline and Week 52)
- Plasma Concentration of Maridebart Cafraglutide at Week 52(Week 52)
- Number of Participants Experiencing Treatment-emergent adverse events (TEAEs)(From first dose to end of trial (up to approximately 65 weeks))
- Number of Participants Experiencing Serious AEs (SAEs)(From screening to end of trial (up to approximately 69 weeks))
研究者
研究点 (23)
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