Obesity and Overweight, Type 2 Diabetes Mellitus (T2DM)
Conditions
Keywords
CK-0045
Brief summary
The goal of this clinical trial is to learn if treatment with CK-0045 improves blood sugar control after a meal in participants with type 2 diabetes mellitus (T2DM) and overweight/obesity. It also aims to learn if CK-0045 can reduce body weight in these patients. The main question it aims to answer is: • Does 16 weeks of treatment with CK-0045 improve blood sugar control after a meal in participants with overweight or obesity and T2DM? Researchers will compare two dose levels of CK-0045 to a placebo arm (a look-alike substance that contains no drug) to see if CK-0045 improves blood sugar control. Participants will: * Have CK-0045 or placebo injected subcutaneously (under the skin) once weekly over a period of 16 weeks. * Visit the clinic 24 times and stay overnight at 2 of the visits. * During the visits blood samples will be collected and several other assessments/examinations will be performed to learn about the effects (and potential side effects) of CK-0045.
Detailed description
Phase 2a, randomized, double-blind, placebo-controlled, parallel group trial with weekly SC dosing of CK-0045 (2 dose levels) or placebo over 16 weeks followed by 8 weeks of follow-up in participants with overweight / obesity and T2DM. The total duration of involvement for each participant, screening through follow-up, will be approximately 30 weeks.
Interventions
DRUGCK-0045
Interleukin-22 agonist
DRUGPlacebo
Placebo (liquid for injection, which includes no active ingredient).
Sponsors
Cytoki Pharma
Profil Institut für Stoffwechselforschung GmbH
CRS Clinical Research Services Mannheim GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel group clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h)) | 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in body weight | 16 weeks | — |
| Change from baseline in total cholesterol, HDL-, LDL-cholesterol, triglycerides, free fatty acids (FFA), and Lp(a) | 16 weeks | — |
| Change from baseline in HbA1c | 16 weeks | — |
| Ctrough, observed | 168 hours | Ctrough, observed (Trough serum concentration observed at the end of the dosing interval (several visits)) |
| Incidence of adverse events | 24 weeks | — |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORTim Heise, MD
Profil Institut für Stoffwechselforschung GmbH
Outcome results
None listed