CK-0045 Proof-of-concept Study in Participants with Overweight / Obesity and Type 2 Diabetes

Launched by CYTOKI PHARMA · Sep 22, 2024

Keywords

ClinConnect Summary

This clinical trial, called the CK-0045 Proof-of-concept Study, is looking to see if a new treatment, CK-0045, can help people with type 2 diabetes and who are overweight or obese. The main goal is to find out if this treatment can improve blood sugar levels after meals and help participants lose some weight. For 16 weeks, participants will receive either CK-0045 or a placebo (a substance that looks like the drug but has no active ingredients) through injections under the skin, once a week. They will visit the clinic frequently for check-ups and tests to monitor their health and how well the treatment works.

To participate, individuals must be between 18 and 74 years old, have been diagnosed with type 2 diabetes for at least six months, and meet certain health criteria, including specific blood sugar levels and body weight. It's important to note that people with certain heart conditions, recent surgeries related to weight loss, or severe skin diseases may not qualify for this trial. Overall, this study aims to provide valuable information about CK-0045 and its potential benefits for managing diabetes and weight in eligible participants.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 18-74 years old male or female diagnosed with type 2 diabetes mellitus ≥ 6 months prior to screening
• • Body Mass Index (BMI) between 27.0 and 40.0 kg/m\^2 at screening
• • Treated with diet and exercise
• • HbA1c 6.5-8.5%, both inclusive, at screening for participants taking 3 antidiabetic medications or HbA1c 6.5-9.0%, both inclusive, at screening for participants taking 2 or less antidiabetic medications at stable doses for at least 3 months prior to screening
• Key Exclusion Criteria:
• • 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.
• • History or signs of clinically relevant skin diseases including but not limited to: psoriasis, atopic dermatitis, eczema, etc., as judged by the investigator.