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

NCT ID: NCT06611930

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-16
• Study Completion Date: 2026-01-07

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Obesity and Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

CK-0045 Dose level 1

Group Type: EXPERIMENTAL

CK-0045

Intervention Type: DRUG

Interleukin-22 agonist

CK-0045 Dose level 2

Group Type: EXPERIMENTAL

CK-0045

Intervention Type: DRUG

Interleukin-22 agonist

Interventions

CK-0045

Interleukin-22 agonist

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

Sponsor Role: collaborator

CRS Clinical Research Services Mannheim GmbH

INDUSTRY

Sponsor Role: collaborator

Cytoki Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tim Heise, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institut für Stoffwechselforschung GmbH

Locations

CRS Clinical Reserach Services Mannheim GmbH

Mannheim, Baden-Wurttemberg, Germany

Profil Institut für Stoffwechselforschung GmbH

Neuss, , Germany

Countries

Germany

Other Identifiers

CK-0045_CS02

Identifier Type: -

Identifier Source: org_study_id