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| ID | Type | Description | Link |
|---|---|---|---|
| J2V-MC-GZLF | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macupatide (Macupatide + Eloralintide Placebo) | Experimental | Participants will be administered macupatide subcutaneously (SC) and eloralintide placebo SC |
|
| Eloralintide (Elorlintide + Macupatide Placebo) | Experimental | Participants will be administered eloralintide SC and macupatide placebo SC |
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| Macupatide + Eloralintide | Experimental | Participants will be administered eloralintide SC and macupatide SC |
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| Placebo (Macupatide Placebo + Elorlintide Placebo) | Placebo Comparator | Participants will be administered eloralintide placebo SC and macupatide placebo SC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macupatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 32 | |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 32 | |
| Change from Baseline in Fasting Glucose |
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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
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:
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
Have been prescribed any of the following receptor agonists (RA) or their combination for any indication within the last 6 months:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC | Recruiting | Gilbert | Arizona | 85296 | United States |
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| Label | URL |
|---|---|
| A Study of Macupatide (LY3532226) and Eloralintide (LY3841136), Alone or in Combination, in Adults With Obesity or Overweight and With Type 2 Diabetes | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Eloralintide | Drug | Administered SC |
|
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| Macupatide Placebo | Drug | Administered SC |
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| Eloralintide Placebo | Drug | Administered SC |
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| Baseline, Week 32 |
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| Clinical Research Partners, LLC | Recruiting | Richmond | Virginia | 23226 | United States |
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| Northwest Clinical Research Center | Recruiting | Bellevue | Washington | 98007 | United States |
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| Universal Research Group | Recruiting | Tacoma | Washington | 98405 | United States |
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| Centro de Investigaciones Metabólicas (CINME) | Recruiting | Buenos Aires | C1056ABI | Argentina |
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| CENUDIAB | Recruiting | Buenos Aires | C1440AAD | Argentina |
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| CEDIC | Recruiting | CABA | C1060ABN | Argentina |
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| Instituto de Investigaciones Clínicas Córdoba | Recruiting | Córdoba | 5000 | Argentina |
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| Clínica Universitaria Reina Fabiola | Recruiting | Córdoba | X50004FHP | Argentina |
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| Go Centro Medico San Nicolás | Recruiting | San Nicolás | 2900 | Argentina |
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| Core Research Group | Recruiting | Brisbane | 4064 | Australia |
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| Emeritus Research | Recruiting | Camberwell | 3124 | Australia |
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| Cornerstone Dermatology | Recruiting | Coorparoo | 4151 | Australia |
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| Momentum Darlinghurst | Recruiting | Darlinghurst, Sydney | 2010 | Australia |
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| CDH Research Institute Pty Ltd | Recruiting | Maroochydore | 4558 | Australia |
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| Momentum Sunshine | Recruiting | Melbourne | 3021 | Australia |
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| AIM Research | Not yet recruiting | Merewether | 2291 | Australia |
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| San Juan Bautista School of Medicine - Clinical Research Unit | Recruiting | Caguas | 00726 | Puerto Rico |
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| Mgcendo Llc | Recruiting | San Juan | 00921 | Puerto Rico |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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