A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD

Part A Inclusion Criteria: * Type 2 diabetes ≥ 12 months. * Treatment with diet and exercise or metformin monotherapy on stable dose for 3 months prior to screening * HbA1c ≤ 10%). * Body Mass Index (BMI) ≥ 25 and ≤ 40.0 kg/m2 Part B Inclusion Criteria * Type 2 diabetes ≥ 12 months. * Treatment with diet and exercise or metformin monotherapy on stable dose for 3 months prior to screening * HbA1c ≤ 10% * BMI ≥ 30 kg/m2 and ≤ 40.0 kg/m2 * Waist circumference ≤ 57 inches * Controlled attenuation parameter by FibroScan * Liver fat fraction ≥ 10% by magnetic resonance imaging (MRI) Part A Exclusion Criteria: * History of type 1 diabetes mellitus (T1DM) * History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator. * Uncontrolled hypertension * Treatment with antihypertensive medication and statins not stable during the past 2 months prior to screening * Treatment with thyroid hormones not stable during the past 3 months prior to screening * History of any weight control treatment, including over-the-counter and herbal medication and supplements, or any medication with a labeled indication for weight loss or weight gain within 3 months prior to screening * History of surgical treatment for obesity * History of heart disease * History of renal disease * History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis, such as a history of cholelithiasis (without cholecystectomy) or alcohol abuse * A history of or active chronic liver disease due to alcohol, auto-immune, HIV, HBV or active HCV-infection or NASH * History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment * Personal or family history of medullary thyroid carcinoma (MTC) or a genetic condition that predispose to MTC (i.e., multiple endocrine neoplasia type 2) * Administration of Vaccines/Immunizations within 14 days prior to first dosing or if scheduled during the study. Vaccination for COVID-19 is allowed during the study if a washout period of 5 days after vaccine administration is followed before dosing. * History of any major surgery within 6 months prior to screening * Participation in any other clinical interventional study receiving active treatment within 30 days or 5 half-lives prior to screening, whichever is longer * History of alcohol or illicit drug abuse including marijuana * Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the investigational product PART B Exclusion Criteria * History of type 1 diabetes mellitus (T1DM) * History of acute proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator * Uncontrolled hypertension (treatment with medications must be stable) * History of any weight control treatment * History of surgical treatment for obesity * History of heart disease * History of renal disease * Subjects with a history or clinically significant active disease of the gastrointestinal, cardiovascular, hepatic, neurological, renal, pancreatic, immunological, dermatological, endocrine, genitourinary or hematological system. * History or current diagnosis of acute or chronic pancreatitis * History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment * History of alcohol or illicit drug abuse including marijuana * Existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the investigational product * Any history of clinically significant chronic liver disease