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

NCT06611930 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-02-20

No results posted yet for this study

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

Interventions

DRUG

CK-0045

Interleukin-22 agonist

DRUG

Placebo

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

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • CRS Clinical Research Services Mannheim GmbH

    collaborator INDUSTRY

  • Cytoki Pharma

    lead INDUSTRY

Principal Investigators

  • Tim Heise, MD · Profil Institut für Stoffwechselforschung GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-06
Primary Completion
2025-09-06
Completion
2025-10-21

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06611930 on ClinicalTrials.gov