Clinical trial NCT06611930: CK-0045 Proof-of-concept Study in Participants With Overweight / Obesity and Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus (T2DM)
Obesity and Overweight
Keywords: CK-0045
Lead sponsor: Cytoki Pharma
Sponsor class: INDUSTRY
Collaborators: name: Profil Institut für Stoffwechselforschung GmbH
name: CRS Clinical Research Services Mannheim GmbH
First posted: 2024-09-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group clinical trial.
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h))
timeFrame: 16 weeks
Secondary outcomes:
measure: Change from baseline in body weight
timeFrame: 16 weeks
measure: Change from baseline in total cholesterol, HDL-, LDL-cholesterol, triglycerides, free fatty acids (FFA), and Lp(a)
timeFrame: 16 weeks
measure: Change from baseline in HbA1c
timeFrame: 16 weeks
measure: Ctrough, observed
timeFrame: 168 hours
measure: Incidence of adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CRS Clinical Reserach Services Mannheim GmbH
state: Baden-Württemberg
city: Neuss
country: Germany
facility: Profil Institut für Stoffwechselforschung GmbH
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Marc Stoffel, MD
role: PRINCIPAL_INVESTIGATOR
References: