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

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
• •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