A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes

Purpose

The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.

Conditions

  • Obesity
  • Overweight
  • Diabetes Mellitus, Type 2

Eligibility

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

Inclusion Criteria

  • Have type 2 diabetes - Have an HbA1c ≥7.5% to ≤10.5% at screening - Have been treated with any of the following, alone or in combination, for at least 3 months prior to screening - Diet and exercise - Stable dose of metformin - Sodium-glucose cotransporter-2 (SGLT2) inhibitor - Have had a stable body weight (<5% body weight gain and/or loss) for the 3 months prior to screening - Have a BMI of 27 or greater at screening

Exclusion Criteria

  • Have any form of diabetes other than type 2 diabetes - Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening - Have any of the following cardiovascular conditions within 3 months prior to screening: - acute myocardial infarction - cerebrovascular accident (stroke) - unstable angina, or - hospitalization due to congestive heart failure - Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years, exceptions include - basal or squamous cell skin cancer - in situ carcinomas of the cervix, or - in situ prostate cancer - Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months: - amylin RA - dual amylin and calcitonin RA - glucagon-like peptide-1 receptor (GLP-1) RA - glucose-dependent insulinotropic peptide (GIP)/GLP-1 RA - GLP-1/glucagon (GCG) RAs, or - GIP/GLP-1/GCG RAs - Have used excluded antihyperglycemic medications within 3 months prior to screening (including, but not limited to, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha-glucosidase inhibitors, thiazolidinediones, and meglitinides - Have used insulin for diabetic control within the prior year (short term use in certain situations allowed

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
Macupatide (Macupatide + Eloralintide Placebo) 		Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC
  • Drug: Macupatide
    Administered SC
    Other names:
    • LY3532226
  • Drug: Eloralintide Placebo
    Administered SC
Experimental
Eloralintide (Elorlintide + Macupatide Placebo) 		Participants will be administered eloralintide SC and macupatide placebo SC
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
  • Drug: Macupatide Placebo
    Administered SC
Experimental
Macupatide + Eloralintide 		Participants will be administered eloralintide SC and macupatide SC
  • Drug: Macupatide
    Administered SC
    Other names:
    • LY3532226
  • Drug: Eloralintide
    Administered SC
    Other names:
    • LY3841136
Placebo Comparator
Placebo (Macupatide Placebo + Elorlintide Placebo) 		Participants will be administered eloralintide placebo SC and macupatide placebo SC
  • Drug: Macupatide Placebo
    Administered SC
  • Drug: Eloralintide Placebo
    Administered SC

Recruiting Locations

Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Gilbert, Arizona 85296
Contact:
480-691-2213

Synexus Clinical Research US, Inc.
Phoenix, Arizona 85020
Contact:
602-200-3814

Pima Heart
Tucson, Arizona 85741
Contact:
520329-4139

SKY Clinical Research Network Group-Brown
Atlanta, Georgia 30331
Contact:
888-659-4363

Teak Research Consults
Lawrenceville, Georgia 30043

AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia 30328

Pivotal Research Solutions
Stonecrest, Georgia 30038

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

Vector Clinical Trials
Las Vegas, Nevada 89128
Contact:
702-750-0000

Premier Research
Trenton, New Jersey 08611
Contact:
609-392-6666

Mercy Family Clinic
Dallas, Texas 75208
Contact:
281-944-3610

Velocity Clinical Research, Dallas
Dallas, Texas 75230

PlanIt Research, PLLC
Houston, Texas 77079
Contact:
713-973-3415

Aavon Clinical Trials
Richmond, Texas 77407
Contact:
713-282-5600

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

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

Kalo Clinical Research
West Valley City, Utah 84120
Contact:
801-363-7353

Eastern Virginia Medical School (EVMS) Medical Group
Norfolk, Virginia 23510
Contact:
757-446-5291

Clinical Research Partners, LLC
Richmond, Virginia 23226
Contact:
804-477-3045

Northwest Clinical Research Center
Bellevue, Washington 98007

Rainier Clinical Research Center
Renton, Washington 98057
Contact:
425-251-1720

Universal Research Group
Tacoma, Washington 98405
Contact:
253-882-1070

San Juan Bautista School of Medicine - Clinical Research Unit
Caguas, Puerto Rico 00726
Contact:
787-743-3038 ext 278

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
317-615-4559
LillyTrials@Lilly.com