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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGH | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 mg/4mg/8mg LY3502970 - Dose Titration Period | Experimental | Participants received escalating oral doses of LY3502970 according to the following dosing schedule:
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| 16 mg LY3502970 (Formulation 1/Formulation 2) - Test Period | Experimental | Participants received 16 mg LY3502970 Formulation 1 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 2 orally QD from Days 29-35 in test period 2. |
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| 16 mg LY3502970 (Formulation 2/Formulation 1) - Test Period | Experimental | Participants received 16 mg LY3502970 Formulation 2 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 1 orally QD from Days 29-35 in test period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3502970 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2 | PK: Cmax of LY3502970 in Formulation 1 and Formulation 2 | Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose |
| PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2 | PK:(AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2 | Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose |
| PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2 | PK: Tmax of LY3502970 in Formulation 1 and Formulation 2 | Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose |
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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 |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 mg/4mg/8mg LY3502970 - Dose Titration Period | Participants received escalating oral doses of LY3502970 according to the following dosing schedule:
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| FG001 | 16 mg LY3502970 (Formulation 1/Formulation 2) - Test Period | Participants received 16 mg LY3502970 Formulation 1 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 2 orally QD from Days 29-35 in test period 2. |
| FG002 | 16 mg LY3502970 (Formulation 2/Formulation 1) -Test Period | Participants received 16 mg LY3502970 Formulation 2 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 1 orally QD from Days 29-35 in test period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose Titration Period |
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| Test Period 1 |
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| Test Period 2 |
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All participants who received at least one dose of LY3502970.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 mg/4mg/8mg LY3502970 - Dose Titration Period | Participants received escalating oral doses of LY3502970 according to the following dosing schedule:
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| Units | Counts |
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| Participants |
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| 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 | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2 | PK: Cmax of LY3502970 in Formulation 1 and Formulation 2 | The pharmacokinetic population consisted of participants from the test period who received at least one dose of LY3502970 and had evaluable PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose |
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From baseline until end of follow-up (up to 49 days)
All participants who received at least one dose of LY3502970. Participants were analyzed based on the actual treatment they received.
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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 | 2 mg LY3502970 - Dose Titration Period | Participants from the dose titration period who received 2 mg LY3502970 were included in this arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | 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 | Mar 14, 2022 | Jan 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2022 | Jan 2, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm. |
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| Primary | PK: Area Under the Plasma Concentration-Time Curve (AUC) From 0 to 24 Hours (AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2 | PK:(AUC (0-24)) of LY3502970 in Formulation 1 and Formulation 2 | The pharmacokinetic population consisted of participants from the test period who received at least one dose of LY3502970 and had evaluable PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour per milliliter (ng*h/mL) | Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose |
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| Primary | PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 in Formulation 1 and Formulation 2 | PK: Tmax of LY3502970 in Formulation 1 and Formulation 2 | The pharmacokinetic population consisted of participants from the test period who received at least one dose of LY3502970 and had evaluable PK samples. | Posted | Median | Full Range | Hours (h) | Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose |
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| 0 |
| 38 |
| 0 |
| 38 |
| 23 |
| 38 |
| EG001 | 4 mg LY3502970 - Dose Titration Period | Participants from the dose titration period who received 4 mg LY3502970 were included in this arm. | 0 | 37 | 0 | 37 | 8 | 37 |
| EG002 | 8 mg LY3502970 - Dose Titration Period | Participants from the dose titration period who received 8 mg LY3502970 were included in this arm. | 0 | 34 | 0 | 34 | 17 | 34 |
| EG003 | 16 mg LY3502970 (Formulation 1) | Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 1) were included in this arm. | 0 | 33 | 0 | 33 | 24 | 33 |
| EG004 | 16 mg LY3502970 (Formulation 2) | Participants from test periods 1 and 2 who received 16 mg LY3502970 (Formulation 2) were included in this arm. | 0 | 34 | 0 | 34 | 24 | 34 |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Catheter site bruise | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Catheter site phlebitis | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Early satiety | General disorders | MedDRA 24.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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