| Trial ID: | L5906 |
| Source ID: | NCT04515576
|
| Associated Drug: |
Ly3493269
|
| Title: |
A Study of LY3493269 in Participants With Type 2 Diabetes
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| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04515576/results
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: LY3493269|DRUG: Dulaglutide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that, at any dose: 1. Results in death 2. Is life-threatening 3. Requires inpatient hospitalization or prolongation of existing hospitalization 4. Results in persistent disability/incapacity 5. Is a congenital anomaly/birth defect 6. Other situations: Based on medical or scientific judgement. A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module, Baseline through final follow-up at Day 57 | Secondary: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269, Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269, Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.|PK: Maximum Observed Drug Concentration (Cmax) of LY3493269, Maximum Observed Drug Concentration (Cmax) of LY3493269, Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.|Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose, Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29., Baseline, Day 29
|
| Sponsor/Collaborators: |
Sponsor: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2020-08-25
|
| Completion Date: |
2021-03-09
|
| Results First Posted: |
2025-01-14
|
| Last Update Posted: |
2025-01-14
|
| Locations: |
Anaheim Clinical Trials, LLC, Anaheim, California, 92801, United States|Miami Research Associates, Miami, Florida, 33143, United States|Clinical Trials of Texas, Inc., San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04515576
|
