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Purpose

The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have type 2 diabetes - Have HbA1c ≥7.5% to ≤10.5% at screening - Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening - Have had a stable body weight for the three months prior to screening - On stable treatment dose of one of the following incretins for at least three months prior to screening: - Injectable semaglutide (1 and 2 milligram (mg)) - Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)

Exclusion Criteria

  • Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma - Have a prior or planned surgical treatment for obesity - Have any of the following cardiovascular conditions within three months prior to screening: - acute myocardial infarction - cerebrovascular accident (stroke) - unstable angina, or - hospitalization due to congestive heart failure - Have used insulin to control blood glucose within the past year (short-term use allowed) - Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening - If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study - Have taken any medications or alternative remedies for weight loss within three months prior to screening

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY3457263 Dose 1 		Participants will receive LY3457263 subcutaneously (SC)
  • Drug: LY3457263
    Administered SC
Experimental
LY3457263 Dose 2 		Participants will receive LY3457263 SC
  • Drug: LY3457263
    Administered SC
Experimental
LY3457263 Dose 3 		Participants will receive LY3457263 SC
  • Drug: LY3457263
    Administered SC
Placebo Comparator
Placebo 		Participants will receive placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

Helios Clinical Research - Phoenix
Phoenix 5308655, Arizona 5551752 85028
Contact:
480-372-5996

Wolverine Clinical Trials
Santa Ana 5392900, California 5332921 92706
Contact:
714-617-2426

Renstar Medical Research
Ocala 4166673, Florida 4155751 34471
Contact:
352-629-5800

Oviedo Medical Research
Oviedo 4167348, Florida 4155751 32765
Contact:
407-977-2705

Balanced Life Health Care Solutions/SKYCRNG
Lawrenceville 4205196, Georgia 4197000 30046
Contact:
770-696-4541

Rophe Adult and Pediatric Medicine/SKYCRNG
Union City 4227777, Georgia 4197000 30291
Contact:
470-317-3604

Elite Clinical Trials
Rexburg 5605242, Idaho 5596512 83440
Contact:
208-356-8977

Investigators Research Group
Brownsburg 4255056, Indiana 4921868 46112
Contact:
317-852-8280

Richmond University Medical Center
Staten Island 5139568, New York 5128638 10310
Contact:
718-818-2430

Southgate Medical Group
West Seneca 5143992, New York 5128638 14224
Contact:
716-712-1004

Lucas Research, Inc.
Morehead City 4480153, North Carolina 4482348 28557
Contact:
252-222-5700

Shelby Clinical Research
Shelby 4491180, North Carolina 4482348 28150
Contact:
980-552-9230

Providence Health Partners-Center for Clinical Research
Dayton 4509884, Ohio 5165418 45439
Contact:
937-297-8994

Alliance for Multispecialty Research, LLC
Norman 4543762, Oklahoma 4544379 73069
Contact:
405-701-8999

Juno Research
Houston 4699066, Texas 4736286 77040
Contact:
713-779-5494

Southern Endocrinology Associates
Mesquite 4710826, Texas 4736286 75149
Contact:
214-693-0904

Texas Diabetes & Endocrinology, P.A.
Round Rock 4724129, Texas 4736286 78681
Contact:
512-334-3505

Consano Clinical Research, LLC
Shavano Park 4728147, Texas 4736286 78231
Contact:
210-545-4900

Texas Valley Clinical Research
Weslaco 4740629, Texas 4736286 78596
Contact:
956-431-8090

Eastside Research Associates
Redmond 5808079, Washington 5815135 98052
Contact:
425-869-6828

Centro de Endocrinologia Alcantara Gonzalez
Bayamón 4562831, Puerto Rico 00956
Contact:
7877870933

Mgcendo Llc
San Juan 4568127, Puerto Rico 00921
Contact:
7874842757

More Details

NCT ID
NCT06897475
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center