a study to evaluate dd01 in overweight/obese subjects with masld/mash

Conditions: NAFLD; NASH

Summary: 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).


Eligibility criteria:
inclusion criteria: * 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 * 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 exclusion criteria: 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

Keywords: liver disease fatty liver non-alcoholic fatty liver disease non-alcoholic steatohepatitis mash masld