NCT04944992 trial results

Inclusion Criteria: * LFC ≥10% as assessed by MRI-PDFF at time of screening. * Body Mass Index (BMI) ≥25 kg/m² and ≤50 kg/m² at time of screening. * Stable weight (based on self-reporting) defined as ≤5% gain or loss of body weight for at least 3 months before screening visit. * No history of Type 2 Diabetes Mellitus (T2DM) OR history of T2DM with an Glycated Hemoglobin (A1C) ≤8.5% at screening AND controlled by diet or a stable dose of metformin for the 3 months before screening. * A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 5 weeks after the last dose of study intervention. * Participants in Taiwan are eligible between the ages of 20 to 70 years of age (inclusive). * Participants in South Korea are eligible between the ages of 19 to 70 years of age (inclusive). Exclusion Criteria: * History of Type 1 Diabetes Mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatitis or pancreatectomy. * Ongoing, inadequately controlled hypothyroidism or hyperthyroidism. * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasm type-2 syndrome. * Recent event (within 6 months prior to screening) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack. * History or evidence of chronic liver disease other than NAFLD or Non-Alcoholic SteatoHepatitis (NASH). * Known history of cirrhosis. * History of acute or chronic pancreatitis. * History of a bariatric surgical procedure or a known clinically significant gastric emptying abnormality. * History of malignancy ≤5 years prior to screening, except for skin cancer or cervical cancer. * Clinically active hematologic disorder. * Diagnosis of human immunodeficiency virus (HIV). * Surgery requiring general anesthesia within 3 months before screening visit. * History of organ transplantation, except for corneal transplant. * Active diabetic proliferative retinopathy or a history of maculopathy. * Untreated obstructive sleep apnea. * History of treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist within 6 months before screening. * History of treatment with thiazolidinediones (ie, pioglitazone, rosiglitazone) within 6 months before screening. * Previous use (within 3 months before screening) or current use of prescription weight-management medications or over-the-counter weight-loss medications or therapies. * Treatment with systemic corticosteroid medication within 3 months before screening. * Current treatment with anticoagulants (eg, warfarin, heparin). * Inability to have an MRI-PDFF performed due to either severe claustrophobia, metallic implant that prevents MRI-PDFF examination, or any other contraindication to MRI-PDFF examination. * Previous or current history of...