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Clinical Trial Details

Trial ID: L5367
Source ID: NCT04235959
Associated Drug: Tirzepatide
Title: A Study of Tirzepatide in Chinese Participants With Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04235959/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Tirzepatide|DRUG: Placebo
Outcome Measures: Primary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration., The number of participants with one or more SAEs is assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module., Baseline up to 43 Weeks | Secondary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hour Post-dose (AUC [0-168]) of Tirzepatide (Cohort 1), PK: AUC \[0-168\] of Tirzepatide., Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).|PK: AUC [0-168] of Tirzepatide (Cohort 2), PK: AUC \[0-168\] of Tirzepatide., Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).|PK: Maximum Concentration (Cmax) of Tirzepatide (Cohort 1), PK: Cmax of Tirzepatide., Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 15 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).|PK: Cmax of Tirzepatide (Cohort 2), PK: Cmax of Tirzepatide., Week 0 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 7 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose); Week 23 - (Pre-dose, 8, 24, 48, 72, 168 hours post-dose).
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2020-10-21
Completion Date: 2021-08-17
Results First Posted: 2023-07-06
Last Update Posted: 2023-07-06
Locations: West China Hospital Sichuan University, Cheng Du, Sichuan, 610041, China|Peking University First Hospital, Beijing, 100034, China
URL: https://clinicaltrials.gov/show/NCT04235959