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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-MC-YDAC | Other Identifier | Eli Lilly And Company |
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The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3841136 + Tirzepatide | Experimental | LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC. |
|
| Placebo + Tirzepatide | Placebo Comparator | Placebo administered SC in combination with tirzepatide given SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline up to 42 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in body weight | Baseline, Week 42 | |
| Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3841136 | Predose up to 42 weeks | |
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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 |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Daytona Beach | Florida | 32117 | United States | ||
| Fortrea Clinical Research Unit |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | 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 |
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| LY3841136 |
| Drug |
Administered SC. |
|
| Placebo | Drug | Administered SC. |
|
| Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136 |
| Predose up to 42 weeks |
| Dallas |
| Texas |
| 75247 |
| United States |
| Fortrea Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |