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| ID | Type | Description | Link |
|---|---|---|---|
| J2S-MC-GZMD | Other Identifier | Eli Lilly and Company |
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This is a 4-part study that includes a Part A, Part B, Part C, and Part D. Parts A and D will study the safety and tolerability of the study drug known as LY3537031 in participants who are overweight and obese. Part B and Part C will study the safety and tolerability of LY3537031 in healthy participants. Part C will contain only Japanese and Chinese healthy participants.
Blood tests will be performed to check how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it. Body weight will be measured. The study will last approximately 49 weeks excluding a screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3537031 Part A (Cohorts 1-7) | Experimental | Multiple-ascending doses of LY3537031 administered subcutaneously (SC) |
|
| Placebo Part A | Placebo Comparator | Placebo administered SC |
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| LY3537031 Part B (Cohorts 8-11) | Experimental | Multiple-ascending doses of LY3537031 administered SC |
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| Placebo Part B | Placebo Comparator | Placebo administered SC |
|
| LY3537031 Part C (Cohorts 12-15) | Experimental | Multiple-ascending doses of LY3537031 administered SC |
|
| Placebo Part C | Placebo Comparator | Placebo administered SC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3537031 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline to Study Completion (Up to 56 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3537031 | Predose on Day 1 through Week 56 | |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3537031 | Predose on Day 1 through Week 56 |
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Inclusion Criteria:
Have a BMI within the range of:
Parts B and C: Weigh 60 kg (80 pounds (lbs)) or more at screening
Have no significant (not more than 5%) self-reported weight gain or loss in the past 3 months prior to screening
Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Research, LLC | Los Alamitos | California | 90720 | United States | ||
| Fortrea Clinical Research Unit |
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| Label | URL |
|---|---|
| A Study of LY3537031 in Overweight, Obese, and Healthy Participants | View source |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| LY3537031 Part D (Cohorts 16-19) | Experimental | Multiple-ascending doses of LY3537031 administered SC |
|
| Placebo Part D | Placebo Comparator | Placebo administered SC |
|
| Placebo | Drug | Administered SC |
|
| Pharmacodynamic (PD): Change from Baseline in Body Weight | Baseline up to Week 56 |
| PD: Change from Baseline in Fasting Glucose | Baseline up to Week 56 |
| PD: Change from Baseline in Oral Glucose Tolerance Test (OGTT) Results | Baseline up to Week 56 |
| PD: Change from Baseline in AUC of Glucose | Baseline Up to Week 56 |
| PD: Change from Baseline in Insulin Levels | Baseline Up to Week 56 |
| PD: Change from Baseline in Connecting Peptide (C-peptide) Levels | Baseline Up to Week 56 |
| PD: Change from Baseline in Cmax of Acetaminophen to Assess the Delay in Gastric Emptying | Baseline up to Week 56 |
| PD: Change from Baseline in AUC of Acetaminophen to Assess the Delay in Gastric Emptying | Baseline Up to Week 56 |
| PD: Change from Baseline in Time to Peak Drug Concentration (Tmax) of Acetaminophen to Assess the Delay in Gastric Emptying | Baseline Up to Week 56 |
| Daytona Beach |
| Florida |
| 32117 |
| United States |
| Clinical Pharmacology of Miami | Miami | Florida | 33172 | United States |
| QPS | Springfield | Missouri | 65802 | United States |
| Fortrea Clinical Research Unit | Dallas | Texas | 75247 | United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |