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 5295903, Arizona 5551752 85296
Contact:
480-691-2213

Central Phoenix Medical Clinic
Phoenix 5308655, Arizona 5551752 85020
Contact:
602-200-3814

SKY Clinical Research Network Group-Brown
Atlanta 4180439, Georgia 4197000 30331
Contact:
888-659-4363

Teak Research Consults
Lawrenceville 4205196, Georgia 4197000 30043

AGILE Clinical Research Trials, LLC
Sandy Springs 4221333, Georgia 4197000 30328

Pivotal Research Solutions
Stonecrest 11748973, Georgia 4197000 30038

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

Vector Clinical Trials
Las Vegas 5506956, Nevada 5509151 89128
Contact:
702-750-0000

Premier Research
Trenton 5105496, New Jersey 5101760 08611
Contact:
609-392-6666

Mercy Family Clinic
Dallas 4684888, Texas 4736286 75208
Contact:
281-944-3610

Velocity Clinical Research, Dallas
Dallas 4684888, Texas 4736286 75230

PlanIt Research, PLLC
Houston 4699066, Texas 4736286 77079
Contact:
713-973-3415

Aavon Clinical Trials
Richmond 4722684, Texas 4736286 77407
Contact:
713-282-5600

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

Kalo Clinical Research
West Valley City 5784607, Utah 5549030 84120
Contact:
801-363-7353

Clinical Research Partners, LLC
Richmond 4781708, Virginia 6254928 23226
Contact:
804-477-3045

Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135 98007

Rainier Clinical Research Center
Renton 5808189, Washington 5815135 98057
Contact:
425-251-1720

San Juan Bautista School of Medicine - Clinical Research Unit
Caguas 4563008, Puerto Rico 00726
Contact:
787-743-3038 ext 278

Mgcendo Llc
San Juan 4568127, 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