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| ID | Type | Description | Link |
|---|---|---|---|
| W8M-MC-MC01 | Other Identifier | Eli Lilly and Company | |
| W8M-MC-CWMM | Other Identifier | Eli Lilly and Company |
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The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macupatide Dose 1 | Experimental | Participants will receive macupatide subcutaneously (SC) |
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| Eloralintide Dose 1 | Experimental | Participants will receive eloralintide SC |
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| Macupatide Dose 1 + Eloralintide Dose 1 | Experimental | Participants will receive macupatide SC and eloralintide SC |
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| Eloralintide Dose 2 | Experimental | Participants will receive eloralintide SC |
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| Macupatide Dose 1 + Eloralintide Dose 2 | Experimental | Participants will receive macupatide SC and eloralintide SC |
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| Eloralintide Dose 3 | Experimental | Participants will receive eloralintide SC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macupatide | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 48 | |
| Change from Baseline in Body Weight | Baseline, Week 36 | |
| Percentage of Participants who Achieve ≥5% Body Weight Reduction |
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Inclusion Criteria:
Exclusion Criteria:
In addition to exclusion criteria in Master Protocol CWMM (NCT06143956):
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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 |
|---|---|---|---|---|---|---|
| The Institute for Liver Health II dba Arizona Clinical Trials - Mesa | Recruiting | Chandler | Arizona | 85225 | United States |
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| Label | URL |
|---|---|
| A clinical trial for adults living with obesity or overweight and without 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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| Macupatide Dose 2 + Eloralintide Dose 3 | Experimental | Participants will receive macupatide SC and eloralintide SC |
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| Placebo | Placebo Comparator | Participants will receive placebo SC |
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| Eloralintide | Drug | Administered SC |
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| Placebo | Drug | Administered SC |
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| Week 36 |
| Percentage of Participants who Achieve ≥10% Body Weight Reduction | Week 36 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 36 |
| Headlands Research - Scottsdale | Recruiting | Scottsdale | Arizona | 85260 | United States |
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| The Institute for Liver Health II dba Arizona Liver Health-Tucson | Recruiting | Tucson | Arizona | 85712 | United States |
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| NorCal Medical Research, Inc | Recruiting | Greenbrae | California | 94904 | United States |
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| Velocity Clinical Research, Huntington Park | Recruiting | Huntington Park | California | 90255 | United States |
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| Peninsula Research Associates | Recruiting | Rolling Hills Estates | California | 90274 | United States |
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| Diablo Clinical Research, Inc. | Recruiting | Walnut Creek | California | 94598 | United States |
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| Stamford Therapeutics Consortium | Recruiting | Stamford | Connecticut | 06905 | United States |
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| New Horizon Research Center | Recruiting | Miami | Florida | 33165 | United States |
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| Indago Research & Health Center, Inc | Recruiting | Miami Lakes | Florida | 33016 | United States |
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| Suncoast Clinical Research, Inc. | Recruiting | New Port Richey | Florida | 34652 | United States |
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| Charter Research - Winter Park | Recruiting | Orlando | Florida | 32803 | United States |
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| Charter Research - Lady Lake | Recruiting | The Villages | Florida | 32162 | United States |
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| Medical Research Partners | Recruiting | Ammon | Idaho | 83406 | United States |
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| Great Lakes Clinical Trials - Ravenswood | Recruiting | Chicago | Illinois | 60640 | United States |
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| Cotton O'Neil Diabetes & Endocrinology | Recruiting | Topeka | Kansas | 66606 | United States |
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| Monroe Biomedical Research - Louisville | Recruiting | Louisville | Kentucky | 40213 | United States |
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| Knownwell | Recruiting | Needham | Massachusetts | 02492 | United States |
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| Lucida Clinical Trials | Recruiting | New Bedford | Massachusetts | 02740 | United States |
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| Headlands Research - Detroit | Recruiting | Southfield | Michigan | 48034 | United States |
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| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Recruiting | Troy | Michigan | 48098 | United States |
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| StudyMetrix Research | Recruiting | City of Saint Peters | Missouri | 63303 | United States |
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| Clinvest Headlands Llc | Recruiting | Springfield | Missouri | 65807 | United States |
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| Las Vegas Medical Research | Recruiting | Las Vegas | Nevada | 89128 | United States |
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| Dent Neurologic Institute | Recruiting | Amherst | New York | 14226 | United States |
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| Rochester Clinical Research, LLC | Recruiting | Rochester | New York | 14609 | United States |
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| Medication Management | Recruiting | Greensboro | North Carolina | 27405 | United States |
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| Monroe Biomedical Research | Recruiting | Monroe | North Carolina | 28112 | United States |
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| Lucas Research, Inc | Recruiting | Morehead City | North Carolina | 28557 | United States |
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| Lucas Research, Inc. | Recruiting | New Bern | North Carolina | 28562 | United States |
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| CTI Clinical Research Center | Recruiting | Cincinnati | Ohio | 45212 | United States |
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| Tribe Clinical Research, LLC | Recruiting | Greenville | South Carolina | 29607 | United States |
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| Quality Medical Research | Recruiting | Nashville | Tennessee | 37211 | United States |
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| IMA Clinical Research Austin | Recruiting | Austin | Texas | 78745 | United States |
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| FutureSearch Trials of Dallas | Recruiting | Dallas | Texas | 75251 | United States |
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| PlanIt Research, PLLC | Recruiting | Houston | Texas | 77079 | United States |
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| Endeavor Clinical Trials | Recruiting | San Antonio | Texas | 78240 | United States |
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| Texas Valley Clinical Research | Recruiting | Weslaco | Texas | 78596 | United States |
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| Sovah Clinical Research-River District | Recruiting | Danville | Virginia | 24541 | United States |
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| Central Washington Health Services Association d/b/a Confluence Health | Recruiting | Wenatchee | Washington | 98801 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| 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 |
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