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TerminatedNCT06611930Updated Feb 20, 2026

CK-0045 Proof-of-concept Study in Participants With Overweight / Obesity and Type 2 Diabetes

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

Why this study was terminated
The study was terminated after the recruitment had been completed due to a decision to discontinue development of CK-0045
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 74 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus (T2DM)
  • Obesity and Overweight

Keywords

  • CK-0045
03

In context

Diabetes Mellitus, Type 2

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    CK-0045 Dose level 1

    Drug: CK-0045

  • Experimental
    CK-0045 Dose level 2

    Drug: CK-0045

Interventions

  • DrugCK-0045

    Interleukin-22 agonist

  • DrugPlacebo

    Placebo (liquid for injection, which includes no active ingredient).

06

What researchers measure

Primary outcomes

  1. Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h))

    Time frame: 16 weeks

Secondary outcomes

  1. Change from baseline in body weight

    Time frame: 16 weeks

  2. Change from baseline in total cholesterol, HDL-, LDL-cholesterol, triglycerides, free fatty acids (FFA), and Lp(a)

    Time frame: 16 weeks

  3. Change from baseline in HbA1c

    Time frame: 16 weeks

  4. Ctrough, observed

    Ctrough, observed (Trough serum concentration observed at the end of the dosing interval (several visits))

    Time frame: 168 hours

  5. Incidence of adverse events

    Time frame: 24 weeks

07

Study locations

2 sites
  • CRS Clinical Reserach Services Mannheim GmbH
    Mannheim, Baden-Wurttemberg 68167, Germany
  • Profil Institut für Stoffwechselforschung GmbH
    Neuss, D-41460, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06611930
Lead sponsor
Cytoki Pharma
Collaborators
Profil Institut für Stoffwechselforschung GmbH, CRS Clinical Research Services Mannheim GmbH
Responsible party
Sponsor
First posted
Sep 25, 2024
Start date
Sep 6, 2024
Primary completion
Sep 6, 2025
Completion
Oct 21, 2025
Last update
Feb 20, 2026

Study contacts

Tim Heise, MD
principal investigator · Profil Institut für Stoffwechselforschung GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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