A Study to Evaluate DD01 in Overweight/Obese Subjects With MASLD/MASH

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

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).

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