| Trial ID: | L2128 |
| Source ID: | NCT03322631
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| Associated Drug: |
Tirzepatide
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| Title: |
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT03322631/results
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: Tirzepatide|DRUG: Placebo
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| 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, Safety was assessed from time of consent through end of study (up to 85 days). Data presented are the number of participants who experienced 1 or more SAEs considered by the investigator to be related to study drug. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this record., Baseline through Day 85 | Secondary: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Tirzepatide, Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of Tirzepatide in plasma., Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration|PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide, Area under the concentration versus time curve from time zero to tau (τ) of Tirzepatide (AUC\[0- τ\]), where tau is dosing interval of (0-168 hours)., Predose, 8, 24, 48, 72 and 168 hours post dose for Day 1 administration, and Predose, 8, 24, 48, and 168 hours post dose for Day 50 administration|Pharmacodynamics (PD): Change From Baseline to 8 Weeks in Fasting Plasma Glucose, Change from baseline to 8 weeks in Fasting Plasma Glucose was measured to investigate the PD effect of Tirzepatide after multiple SC doses administered to Japanese patients with T2DM, Baseline, Week 8
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| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1
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| Enrollment: |
48
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
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| Start Date: |
2017-11-15
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| Completion Date: |
2018-11-28
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| Results First Posted: |
2023-03-23
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| Last Update Posted: |
2023-03-23
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| Locations: |
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., Hachioji, Tokyo, 192-0071, Japan|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., Shinjuku-Ku, Tokyo, 169-0073, Japan
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| URL: |
https://clinicaltrials.gov/show/NCT03322631
|
