- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07215559
- Original Trial
A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Physicians interested in becoming principal investigators please contact
- Email: clinical_inquiry_hub@lilly.com
Study Contact Backup
- Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Phone Number: 317-615-4559
- Email: LillyTrials@Lilly.com
Study Locations
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Buenos Aires, Argentina, C1056ABI
- Recruiting
- Centro de Investigaciones Metabolicas (CINME)
-
Principal Investigator:
- Federico Perez Manghi
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Contact:
- Phone Number: 08003450697
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Buenos Aires, Argentina, C1440AAD
- Recruiting
- CENUDIAB
-
Contact:
- Phone Number: 5491128597742
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Principal Investigator:
- Alejandra Oviedo
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CABA, Argentina, C1060ABN
- Recruiting
- CEDIC
-
Principal Investigator:
- Elizabeth Gelersztein
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Contact:
- Phone Number: 5491121707326
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Córdoba, Argentina, 5000
- Recruiting
- Instituto de Investigaciones Clínicas Córdoba
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Contact:
- Phone Number: 543514253456
-
Principal Investigator:
- Ines Bartolacci
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Córdoba, Argentina, X50004FHP
- Recruiting
- Clínica Universitaria Reina Fabiola
-
Contact:
- Phone Number: 35196098294
-
Principal Investigator:
- Silvina Dominguez Matheu
-
San Nicolás, Argentina, 2900
- Recruiting
- Go Centro Medico San Nicolas
-
Contact:
- Phone Number: 5493364571637
-
Principal Investigator:
- Paulina Lanchiotti
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-
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Botany, Australia, 2019
- Recruiting
- Emeritus Research
-
Principal Investigator:
- Paul Bird
-
Brisbane, Australia, 4064
- Recruiting
- Core Research Group
-
Contact:
- Phone Number: 61738765688
-
Principal Investigator:
- David Colquhoun
-
Camberwell, Australia, 3124
- Recruiting
- Emeritus Research
-
Principal Investigator:
- Sam Francis
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Coorparoo, Australia, 4151
- Recruiting
- Cornerstone Dermatology
-
Principal Investigator:
- Young Jin Kim
-
Contact:
- Phone Number: 07 3397 3200
-
Darlinghurst, Sydney, Australia, 2010
- Recruiting
- Momentum Darlinghurst
-
Principal Investigator:
- Mark Bloch
-
Contact:
- Phone Number: 61 2 9331 7228
-
Maroochydore, Australia, 4558
- Recruiting
- CDH Research Institute Pty Ltd
-
Principal Investigator:
- Hansjoerg Seltenreich
-
Contact:
- Phone Number: 07 5408 0900
-
Melbourne, Australia, 3021
- Recruiting
- Momentum Sunshine
-
Contact:
- Phone Number: 0395096166
-
Principal Investigator:
- King Cheung
-
Merewether, Australia, 2291
- Completed
- AIM Research
-
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Caguas, Puerto Rico, 00726
- Recruiting
- San Juan Bautista School of Medicine - Clinical Research Unit
-
Principal Investigator:
- Loida Gonzalez-Rodriguez
-
Contact:
- Phone Number: 787-754-0101 ext. 5054
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San Juan, Puerto Rico, 00921
- Recruiting
- Mgcendo Llc
-
Contact:
- Phone Number: 7874842757
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Principal Investigator:
- Martha Gomez-Cuellar
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-
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Arizona
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Gilbert, Arizona, United States, 85296
- Recruiting
- Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
-
Contact:
- Phone Number: 480-691-2213
-
Principal Investigator:
- Sunildat Maheshwari
-
Phoenix, Arizona, United States, 85020
- Recruiting
- Synexus Clinical Research US, Inc.
-
Principal Investigator:
- Shawn Searle
-
Tucson, Arizona, United States, 85741
- Recruiting
- Pima Heart
-
Contact:
- Phone Number: 520329-4139
-
Principal Investigator:
- Paul Bejarano
-
-
Florida
-
Sunrise, Florida, United States, 33351
- Recruiting
- Precision Clinical Research
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Principal Investigator:
- Jeffrey Schneider
-
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Georgia
-
Atlanta, Georgia, United States, 30331
- Recruiting
- SKY Clinical Research Network Group-Brown
-
Contact:
- Phone Number: 888-659-4363
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Principal Investigator:
- Tamara Brown
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Lawrenceville, Georgia, United States, 30043
- Recruiting
- Teak Research Consults
-
Principal Investigator:
- Kamar Alabi
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Sandy Springs, Georgia, United States, 30328
- Recruiting
- Agile Clinical Research Trials, LLC
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Principal Investigator:
- Vasundhara Cheekati
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Stonecrest, Georgia, United States, 30038
- Recruiting
- Pivotal Research Solutions
-
Contact:
- Phone Number: 678-825-2887
-
Principal Investigator:
- LaTrenda Perkins
-
Union City, Georgia, United States, 30291
- Recruiting
- Rophe Adult and Pediatric Medicine/SKYCRNG
-
Principal Investigator:
- Dwight Blake
-
Contact:
- Phone Number: 470-317-3604
-
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Nevada
-
Las Vegas, Nevada, United States, 89128
- Recruiting
- Vector Clinical Trials
-
Principal Investigator:
- Cornell Calinescu
-
Contact:
- Phone Number: 702-750-0000
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New Jersey
-
Trenton, New Jersey, United States, 08611
- Recruiting
- Premier Research
-
Contact:
- Phone Number: 609-392-6666
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Principal Investigator:
- Herbert Conaway
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Ohio
-
Dayton, Ohio, United States, 45429
- Recruiting
- PriMed Clinical Research
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Contact:
- Phone Number: 937-534-4201
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Principal Investigator:
- William Randall
-
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Texas
-
Dallas, Texas, United States, 75230
- Recruiting
- Velocity Clinical Research, Dallas
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Principal Investigator:
- Dan Lender
-
Dallas, Texas, United States, 75208
- Recruiting
- Mercy Family Clinic
-
Contact:
- Phone Number: 281-944-3610
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Principal Investigator:
- Ebere Israel Azubuike, MD
-
Houston, Texas, United States, 77043
- Recruiting
- Biopharma Informatic, LLC
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Contact:
- Phone Number: 281-944-3610
-
Principal Investigator:
- Agadadash Kuliev
-
Houston, Texas, United States, 77079
- Recruiting
- PlanIt Research, PLLC
-
Contact:
- Phone Number: 713-973-3415
-
Principal Investigator:
- Prashant Koshy
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Houston, Texas, United States, 77089
- Recruiting
- Research Physicians Network, LLC
-
Principal Investigator:
- Jawad Sarwar, MD
-
Contact:
- Phone Number: 281-944-3610
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Richmond, Texas, United States, 77407
- Recruiting
- Aavon Clinical Trials
-
Contact:
- Phone Number: 713-282-5600
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Principal Investigator:
- Namrata Dass
-
Shavano Park, Texas, United States, 78231
- Recruiting
- Consano Clinical Research, LLC
-
Contact:
- Phone Number: 210-545-4900
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Principal Investigator:
- Michelle Welch
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Weslaco, Texas, United States, 78596
- Recruiting
- Texas Valley Clinical Research
-
Principal Investigator:
- Eduardo Luna
-
Contact:
- Phone Number: 956-431-8090
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Utah
-
West Valley City, Utah, United States, 84120
- Recruiting
- Kalo Clinical Research
-
Contact:
- Phone Number: 801-363-7353
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Principal Investigator:
- Cuper Martinez
-
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Virginia
-
Norfolk, Virginia, United States, 23510
- Recruiting
- Eastern Virginia Medical School (EVMS) Medical Group
-
Principal Investigator:
- Elias Siraj
-
Contact:
- Phone Number: 757-446-5291
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Richmond, Virginia, United States, 23226
- Recruiting
- Clinical Research Partners, LLC
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Contact:
- Phone Number: 804-477-3045
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Principal Investigator:
- Robert Call
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Washington
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Bellevue, Washington, United States, 98007
- Recruiting
- Northwest Clinical Research Center
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Principal Investigator:
- Jeena Vaid
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Renton, Washington, United States, 98057
- Recruiting
- Rainier Clinical Research Center
-
Principal Investigator:
- Frances Broyles
-
Contact:
- Phone Number: 425-251-1720
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Tacoma, Washington, United States, 98405
- Recruiting
- Universal Research Group
-
Principal Investigator:
- Sabrina Benjamin
-
Contact:
- Phone Number: 253-882-1070
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Macupatide (Macupatide + Eloralintide Placebo)
Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC
|
Administered SC
Other Names:
Administered SC
|
|
Experimental: Eloralintide (Elorlintide + Macupatide Placebo)
Participants will be administered eloralintide SC and macupatide placebo SC
|
Administered SC
Other Names:
Administered SC
|
|
Experimental: Macupatide + Eloralintide
Participants will be administered eloralintide SC and macupatide SC
|
Administered SC
Other Names:
Administered SC
Other Names:
|
|
Placebo Comparator: Placebo (Macupatide Placebo + Elorlintide Placebo)
Participants will be administered eloralintide placebo SC and macupatide placebo SC
|
Administered SC
Administered SC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
|
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
|
Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 32
|
Baseline, Week 32
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27721
- J2V-MC-GZLF (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.