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| ID | Type | Description | Link |
|---|---|---|---|
| J4Z-MC-GIDI | Other Identifier | Eli Lilly and Company |
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Study terminated for strategic business reasons
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The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimagrumab Dose 1 + Tirzepatide Placebo | Experimental | Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC |
|
| Bimagrumab Dose 2 + Tirzepatide Placebo | Experimental | Participants will receive bimagrumab SC and tirzepatide placebo SC |
|
| Tirzepatide Dose 1 + Bimagrumab Placebo | Experimental | Participants will receive tirzepatide SC and bimagrumab placebo SC |
|
| Tirzepatide Dose 2 + Bimagrumab Placebo | Experimental | Participants will receive tirzepatide SC and bimagrumab placebo SC |
|
| Bimagrumab Dose 2 + Tirzepatide Dose 1 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimagrumab | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA) | Baseline, Week 36 | |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 36 | |
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Inclusion Criteria:
Exclusion Criteria:
Have a prior or planned surgical treatment for obesity,
Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar state or coma
Have poorly controlled hypertension
Have any of the following cardiovascular conditions within 3 months prior to screening:
Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure
Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes
Have ongoing or a history of bradyarrhythmias other than sinus bradycardia
Have renal impairment
Have a history of symptomatic gallbladder disease within the past 2 years
Have signs and symptoms of any liver disease
Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality
Have a history of acute or chronic pancreatitis
Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening
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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 |
|---|---|---|---|---|---|---|
| Yuma Clinical Trials | Yuma | Arizona | 85364 | United States | ||
| Orange County Research Center |
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| Label | URL |
|---|---|
| A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants with Obesity or Overweight 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 and 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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| Bimagrumab Dose 1 + Tirzepatide Dose 1 |
| Experimental |
Participants will receive bimagrumab SC and tirzepatide SC |
|
| Bimagrumab Dose 2 + Tirzepatide Dose 2 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC |
|
| Bimagrumab Dose 1 + Tirzepatide Dose 2 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC |
|
| Bimagrumab Placebo + Tirzepatide Placebo | Placebo Comparator | Participants will receive bimagrumab placebo SC and tirzepatide placebo SC |
|
|
| Tirzepatide | Drug | Administered SC |
|
|
| Bimagrumab Placebo | Drug | Administered SC |
|
| Tirzepatide Placebo | Drug | Administered SC |
|
| Percentage of Participants Achieving ≥5% Body Weight Reduction |
| Baseline, Week 36 |
| Percentage of Participants Achieving ≥10% Body Weight Reduction | Baseline, Week 36 |
| Percentage of Participants Achieving ≥15% Body Weight Reduction | Baseline, Week 36 |
| Change from Baseline in Waist Circumference | Baseline, Week 36 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 36 |
| Change from Baseline in Waist-to-Height Ratio (WHtR) | Baseline, Week 36 |
| Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI) | Baseline, Week 36 |
| Change from Baseline in Liver Fat by MRI | Baseline, Week 36 |
| Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 36 |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 36 |
| Percent Change from Baseline in Triglycerides (TG) | Baseline, Week 36 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 36 |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab | Predose through Week 52 |
| Lake Forest |
| California |
| 92630 |
| United States |
| Healthy Brain Clinic | Long Beach | California | 90804 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Excel Medical Clinical Trials | Boca Raton | Florida | 33434 | United States |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | United States |
| L&C Professional Medical Research Institute | Miami | Florida | 33144 | United States |
| Global Health Research Center, Inc. | Miami Lakes | Florida | 33016 | United States |
| Charter Research - Winter Park | Orlando | Florida | 32803 | United States |
| Charter Research - Lady Lake | The Villages | Florida | 32162 | United States |
| Balanced Life Health Care Solutions/SKYCRNG | Lawrenceville | Georgia | 30046 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Bingham Memorial Hospital | Blackfoot | Idaho | 83221 | United States |
| Family First Medical Center | Idaho Falls | Idaho | 83404 | United States |
| Deaconess Clinic- Gateway | Newburgh | Indiana | 47630 | United States |
| Kur Research - Columbia Medical | Columbia | Maryland | 21045 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | 27514 | United States |
| Remington-Davis, Inc | Columbus | Ohio | 43215 | United States |
| Central States Research | Tulsa | Oklahoma | 74136 | United States |
| Velocity Clinical Research, Dallas | Dallas | Texas | 75230 | United States |
| PlanIt Research, PLLC | Houston | Texas | 77079 | United States |
| Activian Clinical Research | Kingwood | Texas | 77339 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| CIPREC | Buenos Aires | Buenos Aires F.D. | C1119ACN | Argentina |
| Centro Médico Viamonte | Buenos Aires | Buenos Aires F.D. | C1120AAC | Argentina |
| Consultorio de Investigación Clínica EMO SRL | Buenos Aires | Buenos Aires F.D. | C1405BUB | Argentina |
| CIPREC | Buenos Aires | C1061AAS | Argentina |
| Richmond Clinical Trials | Richmond | British Columbia | V6V 2L1 | Canada |
| Centricity Research Brampton Endocrinology | Brampton | Ontario | L6S 0C6 | Canada |
| Premier Clinical Trial Network | Hamilton | Ontario | L8L 5G4 | Canada |
| Your Research Network | Niagara Falls | Ontario | L2H 1H5 | Canada |
| Centricity Research Pointe-Claire Multispecialty | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Diex Recherche Trois-Rivieres | Trois-Rivières | Quebec | G9A 4P3 | Canada |
| Diex Recherche Quebec | Québec | G1V 4T3 | Canada |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The First Affiliated Hospital of Henan University of Science &Technology | Luoyang Shi | Henan | 471003 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | China |
| Tokuyama Clinic | Mihama-ku,Chiba City | Chiba | 261-0004 | Japan |
| Hayashi Diabetes Internal Medicine Clinic | Chigasaki | Kanagawa | 253-0044 | Japan |
| Shonan Takai Clinic | Kamakura | Kanagawa | 247-0055 | Japan |
| Takai Internal Medicine Clinic | Kamakura-shi | Kanagawa | 247-0056 | Japan |
| Medical Corporation Heishinkai OCROM Clinic | Suita-shi | Osaka | 565-0853 | Japan |
| The Institute of Medical Science, Asahi Life Foundation | Chuo-ku | Tokyo | 103-0002 | Japan |
| Tokyo-Eki Center-building Clinic | Chuo-ku | Tokyo | 103-0027 | Japan |
| Fukuwa Clinic | Chuo-ku | Tokyo | 104-0031 | Japan |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D003924 | Diabetes Mellitus, Type 2 |
| C564245 | Platelet Glycoprotein IV Deficiency |
| 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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| ID | Term |
|---|---|
| C000596367 | bimagrumab |
| 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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