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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
CRS Clinical Reserach Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h))
Time frame: 16 weeks
Change from baseline in body weight
Time frame: 16 weeks
Change from baseline in total cholesterol, HDL-, LDL-cholesterol, triglycerides, free fatty acids (FFA), and Lp(a)
Time frame: 16 weeks
Change from baseline in HbA1c
Time frame: 16 weeks
Ctrough, observed
Ctrough, observed (Trough serum concentration observed at the end of the dosing interval (several visits))
Time frame: 168 hours
Incidence of adverse events
Time frame: 24 weeks
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