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Clinical Trial Details

Trial ID: L7318
Source ID: NCT06305351
Associated Drug: K-757 And K-833 Qd
Title: A Study to Evaluate the Safety, Tolerability, 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 (T2DM)
Interventions: DRUG: K-757 and K-833 QD|DRUG: K-757 and K-833 BID|DRUG: Matching placebo to K-757 and K-833 QD|DRUG: Matching placebo to K-757 and K-833 BID
Outcome Measures: Primary: Proportion of participants who experienced 1 or more treatment-emergent AEs, Up to Day 43 +/- 2 days|Proportion of participants who discontinued study medication due to an AE, Up to Day 43 +/- 2 days | Secondary: Area under the concentration-time curve [AUC] of plasma K-757, when co-administered with K-833, Days 1, 28, 42|AUC of plasma K-833, when co-administered with K-757, Days 1, 28, 42|Maximum concentration [Cmax] of plasma K-757, when co-administered with K-833, Days 1, 28, 42|Cmax of plasma K-833, when co-administered with K-757, Days 1, 28, 42|Time of maximum concentration [Tmax] of plasma K-757, when co-administered with K-833, Days 1, 28, 42|Tmax of plasma K-833, when co-administered with K-757, Days 1, 28, 42|Clearance [Cl] of plasma K-757, when co-administered with K-833, Days 1, 28, 42|Cl of plasma K-833, when co-administered with K-757, Days 1, 28, 42|Volume of distribution at steady-state [Vdss] of plasma K-757, when co-administered with K-833, Days 1, 28, 42|Vdss of plasma K-833, when co-administered with K-757, Days 1, 28, 42|Half-life [t1/2] of plasma K-757, when co-administered with K-833, Days 1, 28, 42|t1/2 of plasma K-833, when co-administered with K-757, Days 1, 28, 42
Sponsor/Collaborators: Sponsor: Kallyope Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 25
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2023-12-07
Completion Date: 2024-06-21
Results First Posted:
Last Update Posted: 2024-11-01
Locations: QPS Miami, Miami, Florida, 33143, United States
URL: https://clinicaltrials.gov/show/NCT06305351