Back to resultsA Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3457263
Placebo
Dulaglutide
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Participants with type 2 diabetes (T2D) at least 6 months before screening
- Participants treated for T2D with diet and exercise, with or without metformin
- Have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.5% and ≤10.5%
- Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²)
- Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
Exclusion Criteria:
- Have a history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine (apart from T2D), hematological, or neurological disorders capable of altering the absorption, metabolism, or elimination of drugs
- Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young
- Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy
- Have known allergies to GLP-1 receptor agonists
Sites / Locations
- Pinnacle Research Group, LLC
- CenExel ACT
- Qps-Mra, Llc
- Atlanta Center of Medical Research
- CenExel-HRI
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
LY3457263 (Alone)
Placebo (Alone)
LY3457263 + Dulaglutide
Placebo + Dulaglutide
Arm Description
LY3457263 administered subcutaneously (SC).
Placebo administered SC.
LY3457263 in combination with dulaglutide administered SC.
Placebo in combination with dulaglutide administered SC.
Outcomes
Primary Outcome Measures
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
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263
PK: AUC of LY3457263
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05377333
Brief Title
A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Official Title
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3457263 Alone and in Combination With GLP-1 RA in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 15, 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2, 2022 (Actual)
Primary Completion Date
November 22, 2023 (Anticipated)
Study Completion Date
November 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LY3457263 (Alone)
Arm Type
Experimental
Arm Description
LY3457263 administered subcutaneously (SC).
Arm Title
Placebo (Alone)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC.
Arm Title
LY3457263 + Dulaglutide
Arm Type
Experimental
Arm Description
LY3457263 in combination with dulaglutide administered SC.
Arm Title
Placebo + Dulaglutide
Arm Type
Experimental
Arm Description
Placebo in combination with dulaglutide administered SC.
Intervention Type
Drug
Intervention Name(s)
LY3457263
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC.
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
LY2189265
Intervention Description
Administered SC.
Primary Outcome Measure Information:
Title
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
Description
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Predose up to 16 weeks
Secondary Outcome Measure Information:
Title
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263
Description
PK: AUC of LY3457263
Time Frame
Pre-dose on Day 1 up to 85 days post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with type 2 diabetes (T2D) at least 6 months before screening
Participants treated for T2D with diet and exercise, with or without metformin
Have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.5% and ≤10.5%
Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²)
Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
Exclusion Criteria:
Have a history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine (apart from T2D), hematological, or neurological disorders capable of altering the absorption, metabolism, or elimination of drugs
Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young
Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy
Have known allergies to GLP-1 receptor agonists
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
CenExel ACT
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Atlanta Center of Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331 2012
Country
United States
Facility Name
CenExel-HRI
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
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