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| ID | Type | Description | Link |
|---|---|---|---|
| W8M-MC-CWMM | Other Identifier | Eli Lilly and Company | |
| W8M-MC-OXA1 | Other Identifier | Eli Lilly and Company | |
| W8M-MC-LAA1 | Other Identifier | Eli Lilly and Company | |
| W8M-MC-LAA2 | Other Identifier | Eli Lilly and Company | |
| W8M-MC-GN01 | Other Identifier | Eli Lilly and Company | |
| W8M-MC-GN02 | Other Identifier | Eli Lilly and Company | |
| W8M-MC-MC01 | Other Identifier | Eli Lilly and Company |
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The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3305677 Obesity ISA OXA1 | Experimental | Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis. |
|
| LY3841136 Obesity ISA LAA1 | Experimental | Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis. |
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| LY3841136 Obesity ISA LAA2 | Experimental | Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis. |
|
| LY3549492 Obesity ISA GN01 | Experimental | Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis. |
|
| LY3549492 Obesity ISA GN02 | Experimental | Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3305677 | Drug | Administered SC. ISA specific interventions will be listed in the ISA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Allocated to Each ISA | Each ISA will detail the intervention specific analysis. | Baseline to Week 6 |
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Inclusion Criteria:
Have a body mass index (BMI)
Have had a stable body weight for the 3 months prior to randomization (<5%) body weight gain and/or loss.
Exclusion Criteria:
Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed >1 year prior to screening.
Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
Have poorly controlled hypertension.
Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
Have any of the following cardiovascular conditions within 3 months prior to screening:
Have a history of symptomatic gallbladder disease within the past 2 years.
Have a lifetime history of suicide attempts.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | 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 |
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 European Union (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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2025 | Mar 31, 2026 |
The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
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| Obesity ISA MC01 | Experimental | Participants will receive macupatide, eloralintide, and placebo SC. Each ISA will detail the intervention specific analysis. |
|
| LY3841136 | Drug | Administered SC. ISA specific interventions will be listed in the ISA. |
|
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| Tirzepatide | Drug | Administered SC. ISA specific interventions will be listed in the ISA. |
|
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| LY3549492 | Drug | Administered orally. ISA specific interventions will be listed in the ISA. |
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| LY3532226 | Drug | Administered SC. ISA specific interventions will be listed in the ISA. |
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| Placebo | Drug | Administered SC. ISA specific interventions will be listed in the ISA. |
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| Placebo | Drug | Administered orally. ISA specific interventions will be listed in the ISA. |
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| HOPE Research Institute | Completed | Phoenix | Arizona | 85032 | United States |
| 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 |
|
| Diablo Clinical Research, Inc. | Recruiting | Walnut Creek | California | 94598 | United States |
|
| Stamford Therapeutics Consortium | Recruiting | Stamford | Connecticut | 06905 | United States |
|
| Northeast Research Institute (NERI) | Completed | Fleming Island | Florida | 32003 | United States |
| New Horizon Research Center | Recruiting | Miami | Florida | 33165 | United States |
|
| Indago Research & Health Center, Inc | Recruiting | Miami Lakes | Florida | 33016 | United States |
|
| Suncoast Clinical Research, Inc. | Recruiting | New Port Richey | Florida | 34652 | United States |
|
| Charter Research - Winter Park | Recruiting | Orlando | Florida | 32803 | United States |
|
| Charter Research - Lady Lake | Recruiting | The Villages | Florida | 32162 | United States |
|
| Pacific Diabetes & Endocrine Center | Completed | Honolulu | Hawaii | 96817 | United States |
| Medical Research Partners | Recruiting | Ammon | Idaho | 83406 | United States |
|
| Great Lakes Clinical Trials - Ravenswood | Active, not recruiting | Chicago | Illinois | 60640 | United States |
| Great Lakes Clinical Trials - Ravenswood | Recruiting | Chicago | Illinois | 60640 | United States |
|
| NorthShore University Health System | Active, not recruiting | Skokie | Illinois | 60077 | United States |
| Iowa Diabetes and Endocrinology Research Center | Recruiting | West Des Moines | Iowa | 50266 | United States |
|
| Cotton O'Neil Diabetes & Endocrinology | Recruiting | Topeka | Kansas | 66606 | United States |
|
| Monroe Biomedical Research - Louisville | Recruiting | Louisville | Kentucky | 40213 | United States |
|
| Knownwell | Recruiting | Needham | Massachusetts | 02492 | United States |
|
| Lucida Clinical Trials | Recruiting | New Bedford | Massachusetts | 02740 | United States |
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| Headlands Research - Detroit | Recruiting | Southfield | Michigan | 48034 | United States |
|
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Recruiting | Troy | Michigan | 48098 | United States |
|
| StudyMetrix Research | Recruiting | City of Saint Peters | Missouri | 63303 | United States |
|
| Clinvest Headlands Llc | Recruiting | Springfield | Missouri | 65807 | United States |
|
| Las Vegas Medical Research | Recruiting | Las Vegas | Nevada | 89128 | United States |
|
| Dent Neurologic Institute | Recruiting | Amherst | New York | 14226 | United States |
|
| Velocity Clinical Research, Syracuse | Recruiting | East Syracuse | New York | 13057 | United States |
|
| North Suffolk Neurology | Completed | Port Jefferson Station | New York | 11776 | United States |
| Rochester Clinical Research, LLC | Recruiting | Rochester | New York | 14609 | United States |
|
| Medication Management | Recruiting | Greensboro | North Carolina | 27405 | United States |
|
| Monroe Biomedical Research | Recruiting | Monroe | North Carolina | 28112 | United States |
|
| Lucas Research, Inc | Recruiting | Morehead City | North Carolina | 28557 | United States |
|
| Lucas Research, Inc. | Recruiting | New Bern | North Carolina | 28562 | United States |
|
| CTI Clinical Research Center | Recruiting | Cincinnati | Ohio | 45212 | United States |
|
| Tribe Clinical Research, LLC | Recruiting | Greenville | South Carolina | 29607 | United States |
|
| Quality Medical Research | Recruiting | Nashville | Tennessee | 37211 | United States |
|
| IMA Clinical Research Austin | Recruiting | Austin | Texas | 78745 | United States |
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| Velocity Clinical Research, Dallas | Recruiting | Dallas | Texas | 75230 | United States |
|
| FutureSearch Trials of Dallas | Recruiting | Dallas | Texas | 75251 | United States |
|
| PlanIt Research, PLLC | Recruiting | Houston | Texas | 77079 | United States |
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| Endeavor Clinical Trials | Recruiting | San Antonio | Texas | 78240 | United States |
|
| Tekton Research - Fredericksburg Road | Completed | San Antonio | Texas | 78258 | United States |
| Texas Valley Clinical Research | Recruiting | Weslaco | Texas | 78596 | United States |
|
| Sovah Clinical Research-River District | Recruiting | Danville | Virginia | 24541 | United States |
|
| Central Washington Health Services Association d/b/a Confluence Health | Recruiting | Wenatchee | Washington | 98801 | United States |
|
| Cicemo Srl | Recruiting | Buenos Aires | 1424 | Argentina |
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| Centro de Investigaciones Metabólicas (CINME) | Recruiting | Buenos Aires | C1056ABI | Argentina |
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| Centro Médico Viamonte | Recruiting | Buenos Aires | C1120AAC | Argentina |
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| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Recruiting | Buenos Aires | C1425AGC | Argentina |
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| Prot_000.pdf |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| 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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| ID | Term |
|---|---|
| C000719829 | mazdutide |
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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