drugset / Trial / NCT06611930

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

NCT06611930 ↗

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated after the recruitment had been completed due to a decision to discontinue development of CK-0045”

Drugs

EvaluationDrugModalityDoseRoute
Subject CK-0045 Unknown — Subcutaneous