NCT06611930

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Cytoki Pharma · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	CK-0045	Interleukin-22 agonist
DRUG	Placebo	Placebo (liquid for injection, which includes no active ingredient).

Timeline

• Start date: 2024-09-06
• Primary completion: 2025-09-06
• Completion: 2025-10-21
• First posted: 2024-09-25
• Last updated: 2026-02-20

Locations

2 sites across 1 country: Germany