DRUG
LY3457263
Administered SC.
A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Status
Completed
Phase
Phase 1
Enrollment
94
Locations
5
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Administered SC.
DRUG
Dulaglutide
Administered SC.
Timeline
From registration to results.
First posted
May 17, 2022
Study start
Jun 2, 2022
Primary completion
Nov 22, 2023
Study completion
Nov 22, 2023
Results posted
Not reported
Registry updated
Jan 11, 2024
Outcomes
What the study measures.
Primary outcomes
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
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 outcomes
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3457263
Time frame · Pre-dose on Day 1 up to 85 days post-dose
PK: AUC of LY3457263
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
5 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Pinnacle Research Group, LLC
Anniston, Alabama, United States
CenExel ACT
Anaheim, California, United States
Qps-Mra, Llc
South Miami, Florida, United States
Atlanta Center of Medical Research
Atlanta, Georgia, United States
CenExel-HRI
Berlin, New Jersey, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Dulaglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
Determination of Resistance Training Status for Patients on Glucagon-Like Peptide-1 Receptor Agonists
Ohio State University · Obesity & Overweight · Diabetes (DM)
Not applicable
Recruiting
300
2026-07
A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Eli Lilly · Type 2 Diabetes
Phase 3
Recruiting
55
2026-07
A Study of Orforglipron (LY3502970) Compared With Dulaglutide in Pediatric Participants With Type 2 Diabetes
Eli Lilly · Diabetes Mellitus, Type 2
Phase 3
Not yet recruiting
170
2026-07
Emulation of the REWIND Cardiovascular Outcomes Trial in Healthcare Claims Data.
Brigham and Women's Hospital · Type 2 Diabetes
Not applicable
Completed
300,000
2026-07
INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD)
Brigham and Women's Hospital · Type 2 Diabetes · Overweight
Not applicable
Completed
60,000
2026-07
Injectable Semaglutide vs Dulaglutide in Individuals at Cardiovascular Risk
Brigham and Women's Hospital · Type 2 Diabetes Mellitus · Obesity
Not applicable
Completed
120,000
2026-07
A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
Eli Lilly · Type 2 Diabetes Mellitus
Phase 3
Completed
13,299
2026-07
Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus
ProGen. Co., Ltd. · Type 2 Diabetes
Phase 2
Not yet recruiting
60
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.