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Clinical Trial Details

Trial ID: L6205
Source ID: NCT02759107
Associated Drug: Tirzepatide
Title: A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02759107/results
Conditions: Healthy|Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Tirzepatide|DRUG: Placebo|DRUG: Dulaglutide
Outcome Measures: Primary: Number of Participants With One or More Serious Adverse Event(s) (SAEs), Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module, Baseline through Day 43 (Part A) and Day 57 (Part B and C) | Secondary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A., Area under the concentration versus time curve from zero to infinity (AUC \[0-∞\]) of Tirzepatide in Part A., Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B, Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part B. τ equals 168 hours., Predose, 8hours(h), 24h,48h,72h,168h postdose|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C, Area under the concentration versus time curve during 1 dosing interval (AUC \[0-τ\]) of Tirzepatide in Part C. τ equals 168 hours., Predose, 8hours(h), 24h,48h,72h,168h postdose|Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C), PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC\[0-2h\]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h)., Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2|Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C), PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC\[0-2h\]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h)., Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23
Sponsor/Collaborators: Sponsor: Eli Lilly and Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 142
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2016-05-11
Completion Date: 2017-06-26
Results First Posted: 2024-01-16
Last Update Posted: 2024-01-16
Locations: Miami Research Associates, South Miami, Florida, 33143, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Singapore, 117597, Singapore
URL: https://clinicaltrials.gov/show/NCT02759107