Status and phase
Conditions
Treatments
About
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).
Enrollment
Sex
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Volunteers
Inclusion and exclusion 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:
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:
Primary purpose
Allocation
Interventional model
Masking
68 participants in 2 patient groups, including a placebo group
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Central trial contact
Senior Director
Data sourced from clinicaltrials.gov
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