NCT06410924已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Treatment With DD01 for 48 Weeks in Overweight/Obese Subjects With MASLD/MASH
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 13
- 主要终点
- Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF
研究概览
简要总结
This is a Phase 2 Study to evaluate the effect of DD01 treatment in overweight/obese patients with metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, 18 to 70 years of age
- •With MASLD or confirmed diagnosis of MASH based on MRI PDFF ≥10% AND 1 of the following:
- •Biopsy proven MASH obtained during Screening which confirms the presence of MASH characterized by a NAS ≥4 with at least 1 in each component (steatosis, ballooning, and lobular inflammation) and fibrosis stage F1 to F
- •A historical biopsy obtained within 6 months may be acceptable OR
- •Meets at least 2 additional metabolic syndrome factors
- •Participants with a BMI ≥25 kg/m2, with stable body weight by history for 3 months
- •Participants must have a waist circumference ≥35 inches (females), or ≥40 inches (males), and must have a waist circumference ≤57 inches (both males and females)
- •Female participants must be non-pregnant, non-lactating or post-menopausal
- •Participants must have the ability and willingness to comply with all Protocol procedures, provide written informed consent and meet all inclusion criteria as outlined in the study protocol
排除标准
- •Participants who have:
- •A history of active or chronic liver disease
- •Liver cirrhosis (fibrosis stage F4), any prior history of hepatic decompensation, including low platelet counts, esophageal varices, ascites, hepatic encephalopathy, splenomegaly, any hospitalization for treatment of chronic liver disease, or a Model for End Stage Liver Disease score of ≥12
- •Recent (within 3 months of Screening) use of therapies associated with development of MASLD/MASH (eg, systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines)
- •Previous surgical treatment for obesity as well as clinically significant GI disorders
- •Type 1 diabetes mellitus, or T2DM on insulin and/or GLP-1 receptor agonist therapy, dipeptidyl peptidase-4 inhibitors, or other therapies
- •Uncontrolled hypertension or uncontrolled dyslipidemia
- •Participated in an investigational study within 30 days prior to dosing or who have participated in another MASLD/MASH interventional study within 60 days prior to Screening
- •With a history or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis, symptomatic cholelithiasis and/or choledocholithiasis, or alcohol abuse
- •With a history of any major surgery within 3 months prior to Screening
- •With heart failure (New York Heart Association Class III or IV) or any cardiovascular event or evidence of active cardiovascular disease
- •With a presence of clinically significant 12-lead ECG findings at Screening, or cardiac arrhythmia requiring medical or surgical treatment within 6 months prior to Screening
- •With personal or family history of medullary thyroid carcinoma (MTC)
- •With a history of renal disease
- •With a history of alcohol or illicit drug abuse
- •A positive test for hepatitis B surface antigen, hepatitis C RNA, or HIV type 1 or type 2 antibody
- •A clinically significant physical examination, ECG, or laboratory finding, as judged by the Investigator, may interfere with any aspect of study conduct or interpretation of results
- •Not met any other exclusion criteria as outlined in the study protocol
研究组 & 干预措施
DD01
Experimental
Study Drug
干预措施: DD01 (Drug)
Placebo
Placebo Comparator
Matching Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects who achieve at least 30% liver fat reduction measured by MRI-PDFF
时间窗: 12 weeks
次要结局
- Change in liver steatosis as assessed by FibroScan(12 weeks and 48 weeks)
- Number of participants with Adverse Events(12 and 48 weeks)
- Change in glucose metabolism parameters(12 and 48 weeks)
- Absolute change in percent liver fat content as assessed by MRI-PDFF(12 weeks and 48 weeks)
- Change in liver stiffness as assessed by Magnetic Resonance Elastography (MRE)(12 weeks and 48 weeks)
- Change in liver stiffness measurements as assessed by FibroScan(12 weeks and 48 weeks)
- Change in liver biochemistry(12 and 48 weeks)
- Effect on pharmacokinetics as assessed by serum concentration-time profiles(Day 1 to 48 weeks)
研究者
研究点 (13)
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