A Study of LY3493269 in Participants With Type 2 Diabetes
Part of paid clinical trials in Anaheim, California.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT04515576
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- LY3493269 — DRUGAdministered SC
- Dulaglutide — DRUGAdministered SC
- Placebo — DRUGAdministered SC
Study Details
The main purpose of this study is to determine the side effects related to LY3493269 in participants with type 2 diabetes. Blood tests will be performed to check concentrations of LY3493269 in the bloodstream. Each enrolled participant will receive LY3493269, dulaglutide, or placebo. The study will last up to approximately 16 weeks for each participant and may include up to 11 visits.
Key Dates
- Start date
- Aug 25, 2020
- Status verified
- Dec 2024
- Primary completion
- Mar 9, 2021
- Completion
- Mar 9, 2021
Study Design
- Enrollment
- 56 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Active Comparator: 1.5 milligrams (mg) DulaglutideParticipants received 1.5 mg dulaglutide subcutaneously (SC) once weekly (QW) for 4 weeks.
- Experimental: 0.3 mg LY3493269Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.
- Experimental: 1 mg LY3493269Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.
- Experimental: 0.75/1.5/3 mg LY3493269Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.
- Experimental: 1.5/3/4/5 mg LY3493269Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.
- Placebo Comparator: PlaceboParticipants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.
Primary Outcome Measure
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 [ Time Frame: Baseline through final follow-up at Day 57 ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | - |
| Miami Research Associates | Miami | Florida | 33143 | - |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | - |
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