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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPIV | Other Identifier | Eli Lilly and Company |
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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide (TZP) + Mibavademab (MIBA) [Group A] | Experimental | Participants will receive TZP subcutaneously (SC) and MIBA for 24 weeks. Participants in Group A will be randomized (Randomization 2) to groups C and D at week 24. |
|
| TZP + Mibavademab-placebo (MIBA-PBO) [Group B] | Experimental | Participants will receive TZP SC and MIBA-PBO SC for 24 weeks. Participants in Group B will be randomized (Randomization 2) to Groups E, F, G, and H at week 24. |
|
| TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C] | Experimental | Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks. |
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| TZP + MIBA [Group D] | Experimental | Participants will receive TZP SC + MIBA SC for 48 weeks. |
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| TZP + MIBA-PBO [Group E] | Experimental | Participants will receive TZP SC + MIBA-PBO SC for 48 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change from Baseline in Body Weight | Baseline, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg) | Baseline, Week 24 | |
| Mean Absolute Change from Baseline for Body Weight (kg) | Baseline, Week 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, Gardena | Gardena | California | 90247 | United States | ||
| Irvine Clinical Research |
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| Label | URL |
|---|---|
| A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity | 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 and 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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|
| TZP + MIBA-PBO then TZP-PBO + MIBA [Group F] | Experimental | Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks. |
|
| TZP + MIBA-PBO then TZP + MIBA [Group G] | Experimental | Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks. |
|
| TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H] | Experimental | Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks. |
|
|
| Mibavademab | Drug | Administered SC |
|
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| Tirzepatide-Placebo | Drug | Administered SC |
|
| Mibavademab-Placebo | Drug | Administered SC |
|
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction |
| Baseline to Week 48 |
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Baseline to Week 48 |
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Baseline to Week 48 |
| Percentage of Participants Who Achieve ≥20 Body Weight Reduction | Baseline to Week 48 |
| Mean Percent Change from Randomization 2 for Body Weight | Week 24, Week 48 |
| Mean Change from Randomization 2 for Body Weight (kg) | Week 24, Week 48 |
| Mean Absolute Change from Randomization 2 for Body Weight (kg) | Week 24, Week 48 |
| Change from Baseline to Week 24 in CoEQ Scores | Baseline, Week 24 |
| Change from Baseline to Week 48 in CoEQ Scores | Baseline, Week 48 |
| Change from Baseline in FCQ-T-r Scores | Baseline, Week 24 |
| Change from Baseline in FCQ-T-r Scores | Baseline, Week 48 |
| Irvine |
| California |
| 92614 |
| United States |
| Velocity Clinical Research, Los Angeles | Los Angeles | California | 90017 | United States |
| Velocity Clinical Research, North Hollywood | North Hollywood | California | 91606 | United States |
| Velocity Clinical Research, Santa Ana | Santa Ana | California | 92704 | United States |
| Velocity Clinical Research, Panorama City | Van Nuys | California | 91405 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Solaris Clinical Research | Meridian | Idaho | 83646 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Velocity Clinical Research - New Orleans | New Orleans | Louisiana | 70119 | United States |
| Hassman Research Institute Marlton Site | Marlton | New Jersey | 08053 | United States |
| Lillestol Research | Fargo | North Dakota | 58104 | United States |
| CTI Clinical Research Center | Cincinnati | Ohio | 45212 | United States |
| South Texas Clinical Research | Corpus Christi | Texas | 78404 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| Juno Research | Houston | Texas | 77040 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| 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 |
|---|---|
| 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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