| Trial ID: | L2311 |
| Source ID: | NCT06611930
|
| Associated Drug: |
Ck-0045
|
| Title: |
CK-0045 Proof-of-concept Study in Participants with Overweight / Obesity and Type 2 Diabetes
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus (T2DM)|Obesity and Overweight
|
| Interventions: |
DRUG: CK-0045|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change from baseline in Area under the plasma glucose (PG) curve after a MMTT (AUCPG(0-4h)), 16 weeks | Secondary: 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|Incidence of adverse events, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Cytoki Pharma | Collaborators: Profil Institut für Stoffwechselforschung GmbH
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
90
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-09-16
|
| Completion Date: |
2025-10
|
| Results First Posted: |
|
| Last Update Posted: |
2025-02-11
|
| Locations: |
Profil Institut für Stoffwechselforschung GmbH, Neuss, D-41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT06611930
|
