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| ID | Type | Description | Link |
|---|---|---|---|
| J4Z-MC-GIDF | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Bimagrumab Dose 2 + Tirzepatide Placebo | Experimental | Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC |
|
| Part A: Bimagrumab Placebo + Tirzepatide Dose 1 | Active Comparator | Participants will receive bimagrumab placebo SC and tirzepatide SC |
|
| Part A: Bimagrumab Placebo + Tirzepatide Dose 2 | Active Comparator | Participants will receive bimagrumab placebo SC and tirzepatide SC |
|
| Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC |
|
| Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2 | 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 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA) | Baseline, Week 24, Week 48 | |
| Change from Baseline in Body Weight | Baseline, Week 24, Week 48 | |
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Inclusion Criteria:
Have a BMI of
≥30 kilograms per square meter (kg/m2) or
≥27 kg/m2 and <30 kg/m2, with at least one of the following weight-related comorbidities:
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
Have at least one laboratory value suggestive of diabetes during screening
Use of metformin, or any other glucose-lowering medications
Have Type 1 Diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar coma
Have poorly controlled hypertension
Have any of the following cardiovascular conditions within 3 months prior to screening:
Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes
Have ongoing or a history of bradyarrhythmias other than sinus bradycardia
Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure
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
Have renal impairment, measured as estimated glomerular filtration rate <30 mL/minute/1.73 m2
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 |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Central Research Associates |
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| Label | URL |
|---|---|
| A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight | 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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| Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC |
|
| Part A: Bimagrumab Placebo + Tirzepatide Placebo | Placebo Comparator | Participants will receive bimagrumab placebo SC and tirzepatide placebo SC |
|
| Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC |
|
| Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC |
|
| Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC |
|
| Part B: Bimagrumab Dose 1 + Tirzepatide Placebo | Experimental | Participants will receive bimagrumab SC and tirzepatide placebo SC |
|
| Part B: 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 24, Week 48 |
| Percentage of Participants Achieving ≥10% Body Weight Reduction | Baseline, Week 24, Week 48 |
| Percentage of Participants Achieving ≥15% Body Weight Reduction | Baseline, Week 24, Week 48 |
| Change from Baseline in Waist Circumference | Baseline, Week 24, Week 48 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 24, Week 48 |
| Change from Baseline in Waist-to-Height Ratio (WHtR) | Baseline, Week 24, Week 48 |
| Percent Change from Baseline in Visceral Adipose Tissue (VAT) | Baseline, Week 24, Week 48 |
| Percent Change from Baseline in Total Body Lean Mass by DXA | Baseline, Week 24, Week 48 |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Jacksonville | Florida | 32256 | United States |
| Altus Research | Lake Worth | Florida | 33461 | United States |
| Suncoast Research Group | Miami | Florida | 33135 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Great Lakes Clinical Trials - Ravenswood | Chicago | Illinois | 60640 | United States |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | United States |
| Keystone Clinical Studies | Plymouth Meeting | Pennsylvania | 19462 | United States |
| Eastside Research Associates | Redmond | Washington | 98052 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| 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 |
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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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