Status:
ACTIVE_NOT_RECRUITING
CK-0045 Proof-of-concept Study in Participants With Overweight / Obesity and Type 2 Diabetes
Lead Sponsor:
Cytoki Pharma
Collaborating Sponsors:
Profil Institut für Stoffwechselforschung GmbH
CRS Clinical Research Services Mannheim GmbH
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Obesity and Overweight
Eligibility:
All Genders
18-74 years
Phase:
PHASE2
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 aim...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 7 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06611930
Start Date
September 16 2024
End Date
January 7 2026
Last Update
August 22 2025
Active Locations (2)
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1
CRS Clinical Reserach Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, Germany, 68167
2
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany, D-41460