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

NCT06611930 | Terminated Phase 2

• 1 other identifier: CK-0045_CS02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Obesity and Overweight

Keywords

CK-0045

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h))

  16 weeks

Secondary Outcomes (5)

• Change from baseline in body weight

  16 weeks

• Change from baseline in total cholesterol, HDL-, LDL-cholesterol, triglycerides, free fatty acids (FFA), and Lp(a)

  16 weeks

• Change from baseline in HbA1c

  16 weeks

• Ctrough, observed

  168 hours

• Incidence of adverse events

  24 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

CK-0045 Dose level 1

EXPERIMENTAL

Drug: CK-0045

CK-0045 Dose level 2

EXPERIMENTAL

Drug: CK-0045

Interventions

CK-0045 DRUG

Interleukin-22 agonist

CK-0045 Dose level 1; CK-0045 Dose level 2

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cytoki Pharma: lead
• Profil Institut für Stoffwechselforschung GmbH: collaborator
• CRS Clinical Research Services Mannheim GmbH: collaborator

Study Sites (2)

CRS Clinical Reserach Services Mannheim GmbH

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Profil Institut für Stoffwechselforschung GmbH

Neuss, D-41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tim Heise, MD

  Profil Institut für Stoffwechselforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel group clinical trial.

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 25, 2024
• Study Start: September 6, 2024
• Primary Completion: September 6, 2025
• Study Completion: October 21, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)