CK-0045 proof-of-concept study

Prior treatment

• Any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure or any other clinically significant history or evidence of poorly controlled cardiovascular disorder(s) as judged by the investigator.
• Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction), have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, gastric banding ), and/or device-based therapy for obesity, or have had device removal within the past 6 months.

Other illness

• History or signs of clinically relevant skin diseases including but not limited to: psoriasis, atopic dermatitis, eczema, etc., as judged by the investigator.

• Male or female person diagnosed with type 2 diabetes mellitus.
• Age between 18 and 74 years, both inclusive, at the time of signing the informed consent.
• Diagnosed with type 2 diabetes mellitus ≥ 6 months prior to screening.
• Treated with diet and exercise and a maximum of three antidiabetic medications at stable doses for at least 3 months prior to screening.
• Body Mass Index (BMI) between 27.0 and 40.0 kg/m^2 and HbA1c 6.5-8.5 for participants taking 3 antidiabetic medications or HbA1c 6.5-9.0% for participants taking 2 or less antidiabetic medications at screening