A Phase 2 interventional study of CK-0045 and Placebo in Type 2 Diabetes Mellitus (T2DM) and Obesity and Overweight, sponsored by Cytoki Pharma. Terminated at 2 sites in Germany. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Cytoki Pharma · Phase 2, Interventional, and Treatment
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:
Participants will:
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Cytoki Pharma is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Drug: Placebo
Drug: CK-0045
Drug: CK-0045
Interleukin-22 agonist
Placebo (liquid for injection, which includes no active ingredient).
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
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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