Type 2 Diabetes Mellitus (T2DM)Phase 2NCT06611930
CK-0045 Proof-of-concept Study in Participants With Overweight / Obesity and Type 2 Diabetes
A Phase 2 study testing CK-0045 in people with Type 2 Diabetes Mellitus (T2DM) and Obesity and Overweight, run by Cytoki Pharma at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Obesity and Overweight
- What is being tested?
- CK-0045
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesGermany
- Study dates
- 6 Sep 2024to 21 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
CRS Clinical Reserach Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167
Profil Institut für Stoffwechselforschung GmbH
Neuss, D-41460
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Proof-of-concept Parallel Group Clinical Trial to Investigate the Efficacy, Safety and Tolerability of Weekly Subcutaneous Dosing of CK-0045 in Participants With Overweight/Obesity and Type 2 Diabetes
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:
Read more
- 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.
- Being tested
- CK-0045, Placebo
- Keywords
- CK-0045
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CK-0045Drug
Interleukin-22 agonist
PlaceboDrug
Placebo (liquid for injection, which includes no active ingredient).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CK-0045 Dose level 1 | Experimental | Not described Receives: Drug: CK-0045 |
| CK-0045 Dose level 2 | Experimental | Not described Receives: Drug: CK-0045 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h))
Measured: 16 weeks
Secondary outcomes (5)
Change from baseline in body weight
Measured: 16 weeks
Change from baseline in total cholesterol, HDL-, LDL-cholesterol, triglycerides, free fatty acids (FFA), and Lp(a)
Measured: 16 weeks
Change from baseline in HbA1c
Measured: 16 weeks
Ctrough, observed
Ctrough, observed (Trough serum concentration observed at the end of the dosing interval (several visits))
Measured: 168 hours
Incidence of adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start6 Sep 2024
- Primary completion6 Sep 2025
- Study completion21 Oct 2025
Why it stopped: The study was terminated after the recruitment had been completed due to a decision to discontinue development of CK-0045
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytoki Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH, CRS Clinical Research Services Mannheim GmbH
- Responsible party
- Sponsor
- Investigators
- Tim Heise, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611930
- Sponsor's protocol ID
- CK-0045_CS02
- Status last verified
- Feb 2026
- First submitted
- 18 Sep 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Proof-of-concept Parallel Group Clinical Trial to Investigate the Efficacy, Safety and Tolerability of Weekly Subcutaneous Dosing of CK-0045 in Participants With Overweight/Obesity and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06611930
- Acronym / sponsor ID
- CK-0045_CS02
- Keywords
- CK-0045
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated after the recruitment had been completed due to a decision to discontinue development of CK-0045
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cytoki PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH, CRS Clinical Research Services Mannheim GmbH
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 6 Sep 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| CK-0045 Dose level 1 | Experimental | Drug: CK-0045 |
| CK-0045 Dose level 2 | Experimental | Drug: CK-0045 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CK-0045Interleukin-22 agonist | Drug | CK-0045 Dose level 1, CK-0045 Dose level 2 |
| PlaceboPlacebo (liquid for injection, which includes no active ingredient). | Drug | Placebo |
Primary outcome
Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h))
Time frame: 16 weeks
5 secondary outcomes
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
Time frame: 168 hours
Incidence of adverse events
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: The study was terminated after the recruitment had been completed due to a decision to discontinue development of CK-0045). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Heise, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CK-0045 in people with Type 2 Diabetes Mellitus (T2DM) and Obesity and Overweight, run by Cytoki Pharma at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated after the recruitment had been completed due to a decision to discontinue development of CK-0045). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h)) (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.