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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGM | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with clarithromycin in healthy participants. This study will last up to approximately 85 days for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3502970 alone (Period 1) | Experimental | Participants received a single 3 milligram (mg) dose of LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug. |
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| Clarithromycin + LY3502970 (Period 2) | Experimental | Participants received below: Day 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H). Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally. Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later |
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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): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970 | PK: AUC(0-∞) of LY3502970 is reported. | Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose |
| PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970 | PK: AUC(0-tlast) of LY3502970 is reported. | Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose |
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 is reported. | Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 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 | 3 mg LY3502970 (Day 1) and 500 mg Clarithromycin Q12H + 3 mg LY3502970 (Day 21) | Participants received below Period 1: Day 1: Single dose of 3 milligram (mg) LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state with no access to food for 4 hours after taking the study drug. Period 2: Day 15 to 31: 500 mg of clarithromycin administered orally every 12 hours (Q12H). Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally. Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later There was a washout period of at least 14 days between Period 1 and Period 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| LY3502970 Alone (Period 1) |
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| Clarithromycin + LY3502970 (Period 2) |
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All participants who received at least one dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Participants received below Period 1: Day 1: Single dose of 3 mg LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state with no access to food for 4 hours after taking the study drug. Period 2: Day 15 to 31: 500 mg of clarithromycin administered orally Q12H. Day 21: 500 mg clarithromycin followed by 3 mg LY3502970 administered orally. Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later There was a washout period of at least 14 days between Period 1 and Period 2. |
| Units | Counts |
|---|---|
| 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): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity AUC(0-∞) of LY3502970 | PK: AUC(0-∞) of LY3502970 is reported. | All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an adverse event (AE) of vomiting that occurred at or before 2 times median time of maximum observed drug concentration (tmax). | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose |
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Baseline up to 43 days
All participants who received at least one dose of study drug regardless of whether they completed all protocol requirements, were included. Participants were analyzed according to the intervention they actually 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 | 3 mg LY3502970 | Participants received a single 3 mg dose of LY3502970 administered orally on Day 1. Participants were fasted overnight and remained in a fasted state for 4 hours after taking the study drug. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | 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 24, 2022 | Apr 17, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2022 | Apr 17, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Clarithromycin | Drug | Administered orally. |
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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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| OG001 | Clarithromycin + LY3502970 (Day 21) | Period 2: Participants received 500 mg of clarithromycin administered orally Q12H from Days 15 to 31. On day 21, one hour after the 500 mg of clarithromycin was administered, a single dose of 3 mg of LY3502970 was administered orally. |
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| Primary | PK: Area Under the Concentration Time Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [ AUC(0-tlast)] of LY3502970 | PK: AUC(0-tlast) of LY3502970 is reported. | All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of tmax. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | ng*h/ mL | Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose |
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| Primary | PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 is reported. | All participants who received at least one dose of LY3502970 and had evaluable PK data. Participants may have been excluded from the PK summary statistics and statistical analysis if a participant had an AE of vomiting that occurred at or before 2 times median time of tmax. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Period 1: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hours Day 1 postdose; Period 2: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 168 and 240 hours Day 21 postdose |
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| 0 |
| 26 |
| 0 |
| 26 |
| 23 |
| 26 |
| EG001 | 500 mg Clarithromycin Q12H | Participants received 500 mg of clarithromycin every 12 hours (Q12H) administered orally from Days 15 to 31. | 0 | 21 | 0 | 21 | 9 | 21 |
| EG002 | 500 mg Clarithromycin Q12H + 3 mg LY3502970 | Participants received 500 mg clarithromycin followed by 3 mg LY3502970 administered orally on day 21. Participants fasted overnight and remained in a fasted state for 4 hours after taking the study drug. Clarithromycin was administered 1 hour prior to LY3502970 dose administration, and a subsequent clarithromycin dose was administered 12 hours later. | 0 | 21 | 0 | 21 | 21 | 21 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Faeces hard | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site bruise | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Taste disorder | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Organic Chemicals |