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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGK | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3502970 Cohort 1 | Experimental | Participants received oral doses of 2 milligrams (mg) LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 once daily (QD). |
|
| LY3502970 Cohort 2 | Experimental | Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD. |
|
| LY3502970 Cohort 3 | Experimental | Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3502970 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in one of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module. | Baseline up to Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1 | PK: AUC[0-tlast] of LY3502970 | Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1 |
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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 |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | Miami | Florida | 33143 | United States | ||
| ICON Early Phase Services Lenexa Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY3502970 Cohort 1 | Participants received oral doses of 2 milligrams (mg) LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 once daily (QD). |
| FG001 | LY3502970 Cohort 2 | Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD. |
| FG002 | LY3502970 Cohort 3 | Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LY3502970 Cohort 1 | Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD. |
| BG001 | LY3502970 Cohort 2 | Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in one of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module. | All enrolled participants who received at least one dose of study drug. | Posted | Number | participants | Baseline up to Day 42 |
Baseline Through End of Safety Follow-Up (Up To Day 42)
All participants who received at least one dose of study drug. As pre-specified per protocol, Adverse Event analysis was planned for each cohort, irrespective of each dose level.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY3502970 Cohort 1 | Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2022 | Aug 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2022 | Aug 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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PK: Cmax of LY3502970 |
| Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
| PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 on Day 1 | PK: Tmax of LY3502970 | Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
| PK: AUC[0-tlast] of LY3502970 on Day 28 | PK: AUC[0-tlast] of LY3502970 | Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
| PK: Cmax of LY3502970 on Day 28 | PK: Cmax of LY3502970 | Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
| PK: Tmax of LY3502970 on Day 28 | PK: Tmax of LY3502970 | Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
| Pharmacodynamics (PD): Change From Baseline in Body Weight | PD: Change From Baseline in Body Weight | Baseline through Day 29 |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| ICON Early Phase Services | San Antonio | Texas | 78209 | United States |
| BG002 | LY3502970 Cohort 3 | Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|
| OG000 | LY3502970 Cohort 1 | Participants received oral doses of 2 mg LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 QD. |
| OG001 | LY3502970 Cohort 2 | Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD. |
| OG002 | LY3502970 Cohort 3 | Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1 | PK: AUC[0-tlast] of LY3502970 | All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram hour per milliliter (ng*h/mL) | Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
|
|
|
| Secondary | PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1 | PK: Cmax of LY3502970 | All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 1. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
|
|
|
| Secondary | PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 on Day 1 | PK: Tmax of LY3502970 | All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 1. | Posted | Median | Full Range | hours (h) | Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
|
|
|
| Secondary | PK: AUC[0-tlast] of LY3502970 on Day 28 | PK: AUC[0-tlast] of LY3502970 | All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 28. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
|
|
|
| Secondary | PK: Cmax of LY3502970 on Day 28 | PK: Cmax of LY3502970 | All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 28. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
|
|
|
| Secondary | PK: Tmax of LY3502970 on Day 28 | PK: Tmax of LY3502970 | All participants who received at least one dose of LY3502970 and had evaluable PK data on Day 28. | Posted | Median | Full Range | h | Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose) |
|
|
|
| Secondary | Pharmacodynamics (PD): Change From Baseline in Body Weight | PD: Change From Baseline in Body Weight | All participants who received at least one dose of LY3502970. | Posted | Mean | Standard Deviation | kilograms (kg) | Baseline through Day 29 |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 19 |
| 24 |
| EG001 | LY3502970 Cohort 2 | Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD. | 0 | 24 | 0 | 24 | 20 | 24 |
| EG002 | LY3502970 Cohort 3 | Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD. | 0 | 24 | 0 | 24 | 13 | 24 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |