A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes
Recruiting · NCT07215559 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
42 locations listed across 10 US states.
- Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC - Gilbert, Arizona, United States
- Synexus Clinical Research US, Inc. - Phoenix, Arizona, United States
- Pima Heart - Tucson, Arizona, United States
- Precision Clinical Research - Sunrise, Florida, United States
- SKY Clinical Research Network Group-Brown - Atlanta, Georgia, United States
- Teak Research Consults - Lawrenceville, Georgia, United States
- AGILE Clinical Research Trials, LLC - Sandy Springs, Georgia, United States
- Pivotal Research Solutions - Stonecrest, Georgia, United States
- Rophe Adult and Pediatric Medicine/SKYCRNG - Union City, Georgia, United States
- Vector Clinical Trials - Las Vegas, Nevada, United States
- Premier Research - Trenton, New Jersey, United States
- PriMED Clinical Research - Dayton, Ohio, United States
- Mercy Family Clinic - Dallas, Texas, United States
- Velocity Clinical Research, Dallas - Dallas, Texas, United States
- Biopharma Informatic, LLC - Houston, Texas, United States
- PlanIt Research, PLLC - Houston, Texas, United States
- Research Physicians Network, LLC - Houston, Texas, United States
- Aavon Clinical Trials - Richmond, Texas, United States
- Consano Clinical Research, LLC - Shavano Park, Texas, United States
- Texas Valley Clinical Research - Weslaco, Texas, United States
- Kalo Clinical Research - West Valley City, Utah, United States
- Eastern Virginia Medical School (EVMS) Medical Group - Norfolk, Virginia, United States
- Clinical Research Partners, LLC - Richmond, Virginia, United States
- Northwest Clinical Research Center - Bellevue, Washington, United States
- Rainier Clinical Research Center - Renton, Washington, United States
- Universal Research Group - Tacoma, Washington, United States
- Emeritus Research - Botany, Australia
- Core Research Group - Brisbane, Australia
- Centro de Investigaciones Metabólicas (CINME) - Buenos Aires, Argentina
- CENUDIAB - Buenos Aires, Argentina
- CEDIC - CABA, Argentina
- San Juan Bautista School of Medicine - Clinical Research Unit - Caguas, Puerto Rico
- Emeritus Research - Camberwell, Australia
- Cornerstone Dermatology - Coorparoo, Australia
- Instituto de Investigaciones Clínicas Córdoba - Córdoba, Argentina
- Clínica Universitaria Reina Fabiola - Córdoba, Argentina
- Momentum Darlinghurst - Darlinghurst, Sydney, Australia
- CDH Research Institute Pty Ltd - Maroochydore, Australia
- Momentum Sunshine - Melbourne, Australia
- AIM Research - Merewether, Australia
- Mgcendo Llc - San Juan, Puerto Rico
- Go Centro Medico San Nicolás - San Nicolás, Argentina