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

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

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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes Mellitus (T2DM); Obesity and Overweight
• Intervention / Treatment: Drug: CK-0045; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Neuss, Germany, D-41460
    • Profil Institut für Stoffwechselforschung GmbH
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, 68167
      • CRS Clinical Reserach Services Mannheim GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo (liquid for injection, which includes no active ingredient).
Experimental: CK-0045 Dose level 1	Drug: CK-0045; Interleukin-22 agonist
Experimental: CK-0045 Dose level 2	Drug: CK-0045; Interleukin-22 agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h))	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events		24 weeks
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	Ctrough, observed (Trough serum concentration observed at the end of the dosing interval (several visits))	168 hours

Collaborators and Investigators

• Sponsor: Cytoki Pharma
• Collaborators: Profil Institut für Stoffwechselforschung GmbH; CRS Clinical Research Services Mannheim GmbH
• Investigators: Principal Investigator: Tim Heise, MD, Profil Institut für Stoffwechselforschung GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2024
• Primary Completion (Actual): September 6, 2025
• Study Completion (Actual): October 21, 2025

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 22, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: CK-0045
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CK-0045_CS02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No