Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611930
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
CK-0045 Proof-of-concept Study in Participants With Overweight Obesity and Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Single-centre 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 OverweightObesity and Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 overweightobesity 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 assessmentsexaminations will be performed to learn about the effects and potential side effects of CK-0045
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 assessmentsexaminations will be performed to learn about the effects and potential side effects of CK-0045
Detailed Description:
Phase 2a single-center 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None