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| ID | Type | Description | Link |
|---|---|---|---|
| J3R-JE-YDAB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to learn about the side effects of LY3841136 alone and in combination with tirzepatide, when given to Japanese participants with obese or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Part A of the study will last about 28 weeks and may include up to 17 visits. Part B of the study will last about 40 weeks and may include up to 29 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY3841136 | Experimental | LY3841136 administered subcutaneously (SC) |
|
| Part A: Placebo | Placebo Comparator | Placebo administered SC |
|
| Part B: Tirzepatide + LY3841136-Placebo | Experimental | Tirzepatide administered SC along with volume-matched LY3841136-Placebo administered SC |
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| Part B: LY3841136 + Tirzepatide-Placebo | Experimental | LY3841136 administered SC along with volume-matched Tirzepatide-Placebo administered SC |
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| Part B: LY3841136 + Tirzepatide | Experimental | LY3841136 administered SC along with Tirzepatide administered SC |
|
| Part B: LY3841136-Placebo + Tirzepatide-Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3841136 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 22 | A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Week 22 |
| Part B: Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration at Week 34 | A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Week 34 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136 | PK: AUC of LY3841136 alone | Predose through Week 22 |
| Part A PK: Maximum Observed Concentration (Cmax) of LY3841136 |
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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 |
|---|---|---|---|---|---|---|
| P-One Clinic | Hachiōji | Tokyo | 192-0071 | Japan | ||
| Sumida Hospital |
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| Label | URL |
|---|---|
| A Study of LY3841136 in Japanese Participants with Obesity or Overweight | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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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Volume-matched LY3841136-Placebo administered SC along with volume-matched Tirzepatide-Placebo administered SC |
|
| LY3841136-Placebo | Drug | Administered SC |
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| Tirzepatide | Drug | Administered SC |
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| Tirzepatide-Placebo | Drug | Administered SC |
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PK: Cmax of LY3841136 alone
| Predose through Week 22 |
| Part A Pharmacodynamics (PD): Change From Baseline in Body Weight at Week 12 | PD: Change from baseline in body weight | Baseline through Week 12 |
| Part B PK: AUC of LY3841136 in Combination with Tirzepatide | PK: AUC of LY3841136 in combination with tirzepatide | Predose through Week 34 |
| Part B PK: Cmax of LY3841136 in Combination with Tirzepatide | PK: Cmax of LY3841136 in combination with tirzepatide | Predose through Week 34 |
| Part B PD: Change From Baseline in Body Weight at Week 24 | PD: Change from baseline in body weight | Baseline through Week 24 |
| Sumida-ku |
| Tokyo |
| 130-0004 |
| Japan |
| Hakata Clinic | Fukuoka | 812-0025 | Japan |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |