Testing CK-0045 for better blood sugar control in overweight or obese patients with type 2 diabetes
A Randomized, Single-centre, 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
This study is testing if a new medication called CK-0045 can help overweight or obese people with type 2 diabetes better control their blood sugar after meals and lose weight.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Cytoki Pharma Industry-sponsored |
| Locations | 1 site (Neuss) |
| Trial ID | NCT06611930 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of CK-0045 in improving post-meal blood sugar control and reducing body weight in participants with type 2 diabetes mellitus (T2DM) who are overweight or obese. It is a Phase 2a, single-center, randomized, double-blind, placebo-controlled trial where participants will receive either CK-0045 or a placebo via subcutaneous injection once weekly for 16 weeks. The study will involve 24 clinic visits, including overnight stays, to monitor the effects and potential side effects of the treatment. The primary outcome is to determine if CK-0045 significantly improves blood sugar levels compared to placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-74 with a diagnosis of type 2 diabetes for at least 6 months and a BMI between 27.0 and 40.0 kg/m².
Not a fit: Patients with recent serious cardiovascular events or poorly controlled cardiovascular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide improved blood sugar control and weight loss for patients with type 2 diabetes and obesity.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Neuss
- Profil Institut für Stoffwechselforschung GmbH — Neuss, Germany (Recruiting)
Study contacts
- Principal investigator: Marc Stoffel, MD — Profil Institut für Stoffwechselforschung GmbH
- Study coordinator: Anne Louise Kjoelbye, PhD
- Email: alk@cytokipharma.com
- Phone: 004530451043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.