CK-0045 proof-of-concept study
Key facts
- Where
- Mannheim és Neuss, NémetországSee the 2 sites
- Phase
- 2. fázis
Where in Németország
- CRS Clinical Research Services Mannheim GmbHMannheim, NémetországNo longer taking part
- PROFIL Institut fuer Stoffwechselforschung GmbHNeuss, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cytoki Pharma ApS
- Trial code
- EU 2024-514191-41-00
- Record updated
- 2025. július 15.
- Original description
To investigate the effects of 16 weeks of treatment with CK-0045 at two different dose levels versus placebo on glucose metabolism after a mixed meal tolerance test (MMTT) in participants with overweight / obesity and Type 2 diabetes.Read full original descriptionShow less
A randomized, double-blind, placebo-controlled proof-of-concept parallel group clinical trial to investigate the efficacy, safety and tolerability of weekly subcutaneous (SC) dosing of CK-0045 in participants with overweight / obesity and Type 2 diabetes
To investigate the effects of 16 weeks of treatment with CK-0045 at two different dose levels versus placebo on glucose metabolism after a mixed meal tolerance test (MMTT) in participants with overweight / obesity and Type 2 diabetes.
Inclusion: 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.
Exclusion: 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.