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Keep this study
Lead
Neuraly, Inc.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
1. 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 F3. A historical biopsy obtained within 6 months may be acceptable OR
2. 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
You may not be if
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
Clareo Health | A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH
