A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Part of paid clinical trials in Anniston, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT05377333
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- LY3457263 — DRUGAdministered SC.
- Placebo — DRUGAdministered SC.
- Dulaglutide — DRUGAdministered SC.
Study Details
The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.
Key Dates
- Start date
- Jun 2, 2022
- Status verified
- Jan 2024
- Primary completion
- Nov 22, 2023
- Completion
- Nov 22, 2023
Study Design
- Enrollment
- 94 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: LY3457263 (Alone)LY3457263 administered subcutaneously (SC).
- Placebo Comparator: Placebo (Alone)Placebo administered SC.
- Experimental: LY3457263 + DulaglutideLY3457263 in combination with dulaglutide administered SC.
- Experimental: Placebo + DulaglutidePlacebo in combination with dulaglutide administered SC.
Primary Outcome Measure
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Predose up to 16 weeks ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | - |
| CenExel ACT | Anaheim | California | 92801 | - |
| Qps-Mra, Llc | South Miami | Florida | 33143 | - |
| Atlanta Center of Medical Research | Atlanta | Georgia | 30331 2012 | - |
| CenExel-HRI | Berlin | New Jersey | 08009 | - |
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