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

Cytoki Pharma

Status and phase: Enrolling; Phase 2

Conditions: Obesity and Overweight; Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Placebo; Drug: CK-0045

Study type: Interventional

Funder types: Industry

Identifiers

NCT06611930

CK-0045_CS02

Details and patient eligibility

About

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.

Full description

Phase 2a, single-center, 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

CK-0045 Dose level 1

Experimental group

Treatment:

Drug: CK-0045

CK-0045 Dose level 2

Experimental group

Treatment:

Drug: CK-0045