A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

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

  • Type 2 Diabetes

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, Arizona 85028
Contact:
480-372-5996

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

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

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

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

Physicians Research Associates
Lawrenceville, Georgia 30046
Contact:
678-252-2375

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

North Georgia Clinical Research
Woodstock, Georgia 30189
Contact:
678-494-5735

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

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

Clinical Research of Philadelphia
Pennington, New Jersey 08534
Contact:
215-676-6696

NYC Research INC
Long Island City, New York 11106
Contact:
516-574-9232

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

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

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

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

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

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

Frontier Clinical Research, LLC
Scottdale, Pennsylvania 15683
Contact:
724-220-5281

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

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

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

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

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

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

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

Mgcendo Llc
San Juan, Puerto Rico 00921
Contact:
7874842757

More Details

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