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

Neuraly, Inc.13 个研究点分布在 1 个国家目标入组 67 人2024年6月13日

适应症NAFLD NASH

干预措施DD01 Placebo

概览

阶段: 2 期
干预措施: DD01
疾病 / 适应症: NAFLD
发起方: Neuraly, Inc.
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
状态: 已完成
最后更新: 昨天

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验相关资讯

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).

注册库

clinicaltrials.gov

开始日期

2024年6月13日

结束日期

2026年4月21日

最后更新

昨天

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Neuraly, Inc.

责任方

Sponsor

入排标准

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

研究组 & 干预措施

DD01

Study Drug

干预措施: DD01

Placebo

Matching Placebo

干预措施: Placebo

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)