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Clinical Trial Details

Trial ID: L3912
Source ID: NCT05890950
Associated Drug: K-757 And K-833
Title: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of K-757 and K-833 in Overweight/Obese Patients With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Obesity|Type 2 Diabetes Mellitus in Obese
Interventions: DRUG: K-757 and K-833|DRUG: Matching placebo to K-757 and K-833
Outcome Measures: Primary: Proportion of participants who experienced 1 or more treatment-emergent AEs, After treatment with the combination of K-757 and K-833, Up to Day 42 +/- 2days|Proportion of participants who discontinued study medication due to an AE, After treatment with the combination of K-757 and K-833, Up to Day 42 +/- 2days | Secondary: Area under the concentration-time curve [AUC] of plasma K-757, when co-administered with K-833, Days 14 and 28|AUC of plasma K-833, when co-administered with K-757, Days 14 and 28|Maximum concentration [Cmax] of plasma K-757, when co-administered with K-833, Days 14 and 28|Cmax of plasma K-833, when co-administered with K-757, Days 14 and 28|Time of maximum concentration [Tmax] of plasma K-757, when co-administered with K-833, Days 14 and 28|Tmax of plasma K-833, when co-administered with K-757, Days 14 and 28|Clearance [Cl] of plasma K-757, when co-administered with K-833, Days 14 and 28|Cl of plasma K-833, when co-administered with K-757, Days 14 and 28|Volume of distribution at steady-state [Vdss] of plasma K-757, when co-administered with K-833, Days 14 and 28|Vdss of plasma K-833, when co-administered with K-757, Days 14 and 28|Half-life [t1/2] of plasma K-757, when co-administered with K-833, Days 14 and 28|t1/2 of plasma K-833, when co-administered with K-757, Days 14 and 28
Sponsor/Collaborators: Sponsor: Kallyope Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-13
Completion Date: 2023-07-12
Results First Posted:
Last Update Posted: 2023-10-05
Locations: QPS, LLC, Newark, Delaware, 19711, United States
URL: https://clinicaltrials.gov/show/NCT05890950