A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Reduction With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight and With Type 2 Diabetes
Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
RECRUITING
Gilbert
Central Phoenix Medical Clinic
RECRUITING
Phoenix
Pima Heart
NOT_YET_RECRUITING
Tucson
Georgia
SKY Clinical Research Network Group-Brown
RECRUITING
Atlanta
Teak Research Consults
RECRUITING
Lawrenceville
AGILE Clinical Research Trials, LLC
RECRUITING
Sandy Springs
Pivotal Research Solutions
RECRUITING
Stonecrest
Rophe Adult and Pediatric Medicine/SKYCRNG
RECRUITING
Union City
New Jersey
Premier Research
RECRUITING
Trenton
Nevada
Vector Clinical Trials
RECRUITING
Las Vegas
Texas
Mercy Family Clinic
RECRUITING
Dallas
Velocity Clinical Research, Dallas
RECRUITING
Dallas
PlanIt Research, PLLC
RECRUITING
Houston
Aavon Clinical Trials
RECRUITING
Richmond
Consano Clinical Research, LLC
RECRUITING
Shavano Park
Texas Valley Clinical Research
NOT_YET_RECRUITING
Weslaco
Utah
Kalo Clinical Research
RECRUITING
West Valley City
Virginia
Eastern Virginia Medical School (EVMS) Medical Group
NOT_YET_RECRUITING
Norfolk
Clinical Research Partners, LLC
RECRUITING
Richmond
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Rainier Clinical Research Center
RECRUITING
Renton
Universal Research Group
NOT_YET_RECRUITING
Tacoma
Other Locations
Argentina
Centro de Investigaciones Metabólicas (CINME)
NOT_YET_RECRUITING
Buenos Aires
CENUDIAB
NOT_YET_RECRUITING
Buenos Aires
CEDIC
NOT_YET_RECRUITING
Caba
Clínica Universitaria Reina Fabiola
NOT_YET_RECRUITING
Córdoba
Instituto de Investigaciones Clínicas Córdoba
NOT_YET_RECRUITING
Córdoba
Go Centro Medico San Nicolás
NOT_YET_RECRUITING
San Nicolás
Australia
Emeritus Research
RECRUITING
Botany
Core Research Group
NOT_YET_RECRUITING
Brisbane
Emeritus Research
RECRUITING
Camberwell
Cornerstone Dermatology
RECRUITING
Coorparoo
Momentum Darlinghurst
RECRUITING
Darlinghurst, Sydney
CDH Research Institute Pty Ltd
NOT_YET_RECRUITING
Maroochydore
Momentum Sunshine
RECRUITING
Melbourne
AIM Research
NOT_YET_RECRUITING
Merewether
Puerto Rico
San Juan Bautista School of Medicine - Clinical Research Unit
RECRUITING
Caguas
Mgcendo Llc
RECRUITING
San Juan
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-10-16
Estimated Completion Date: 2027-05
Participants
Target number of participants: 200
Treatments
Experimental: Macupatide (Macupatide + Eloralintide Placebo)
Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC
Experimental: Eloralintide (Elorlintide + Macupatide Placebo)
Participants will be administered eloralintide SC and macupatide placebo SC
Experimental: Macupatide + Eloralintide
Participants will be administered eloralintide SC and macupatide SC
Placebo_comparator: Placebo (Macupatide Placebo + Elorlintide Placebo)
Participants will be administered eloralintide placebo SC and macupatide placebo SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company