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| ID | Type | Description | Link |
|---|---|---|---|
| J1X-MC-GZHA | Other Identifier | Eli Lilly and Company |
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This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo - SC | Placebo Comparator | Participants received Placebo subcutaneously (SC). |
|
| 0.5 mg LY3493269 IV | Experimental | Participants received 0.5 mg LY3493269 intravenously (IV). |
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| 0.15 mg LY3493269 SC | Experimental | Participants received 0.15 mg LY3493269 SC. |
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| 0.5 mg LY3493269 SC | Experimental | Participants received 0.5 mg LY3493269 SC. |
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| 1.5 mg LY3493269 SC | Experimental | Participants received 1.5 mg LY3493269 SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3493269 - SC | Drug | Administered SC |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through final follow-up (Up To Day 43) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269 | Pharmacokinetics (PK): Area Under the Concentration time curve from time zero to infinity (AUC 0-∞) of LY3493269 | Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination |
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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 | Placebo SC | Participants received Placebo subcutaneously (SC). |
| FG001 | 0.15 mg LY3493269 SC | Participants received 0.15 milligrams (mg) LY3493269 SC. |
| FG002 | 0.5 mg LY3493269 SC | Participants received 0.5 mg LY3493269 SC. |
| FG003 | 0.5 mg LY3493269 IV | Participants received 0.5 mg LY3493269 intravenously (IV). |
| FG004 | 1.5 mg LY3493269 SC | Participants received 1.5 mg LY3493269 SC. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo SC | Participants received Placebo subcutaneously(SC). |
| BG001 | 0.15 mg LY3493269 SC | Participants received 0.15 mg LY3493269 SC. |
| 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through final follow-up (Up To Day 43) |
|
Baseline Up To 43 Days
All participants who received at least one dose of study drug.
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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 | Placebo SC | Participants received Placebo SC. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus tachycardia | Cardiac disorders | MedDRA 22.1 | 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 | Oct 10, 2019 | Mar 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 28, 2020 | Mar 2, 2021 | SAP_001.pdf |
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| Placebo - SC | Drug | Administered SC |
|
| LY3493269 - IV | Drug | Administered IV |
|
| PK: Maximum Concentration (Cmax) of LY3493269 | PK: Maximum Concentration (Cmax) of LY3493269 | Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination |
| PK: Time to Maximum Concentration (Tmax) of LY3493269 | PK: Time to Maximum Concentration (Tmax) of LY3493269 | Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination |
| BG002 | 0.5 mg LY3493269 SC | Participants received 0.5 mg LY3493269 SC. |
| BG003 | 0.5 mg LY3493269 IV | Participants received 0.5 mg LY3493269 intravenously (IV). |
| BG004 | 1.5 mg LY3493269 SC | Participants received 1.5 mg LY3493269 SC. |
| BG005 | Total | Total of all reporting groups |
| 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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| OG002 | 0.5 mg LY3493269 SC | Participants received 0.5 mg LY3493269 SC. |
| OG003 | 0.5 mg LY3493269 IV | Participants received 0.5 mg LY3493269 intravenously (IV). |
| OG004 | 1.5 mg LY3493269 SC | Participants received 1.5 mg LY3493269 SC. |
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC 0-∞) of LY3493269 | Pharmacokinetics (PK): Area Under the Concentration time curve from time zero to infinity (AUC 0-∞) of LY3493269 | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hour per milliliter (ng*h/mL) | Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 and early termination |
|
|
|
| Secondary | PK: Maximum Concentration (Cmax) of LY3493269 | PK: Maximum Concentration (Cmax) of LY3493269 | All participants who received at least one dose of study drug. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination |
|
|
|
| Secondary | PK: Time to Maximum Concentration (Tmax) of LY3493269 | PK: Time to Maximum Concentration (Tmax) of LY3493269 | All participants who received at least one dose of study drug. | Posted | Median | Full Range | hours (hr) | Day 1: Predose, 6, 12 hours; Day 2: 24 hours; Day 3: 48 hours; Day 4: 72 hours; Day 5: 96 hours; Day 6:120 hours; Day 8:168 hours; and any time during the visit on Day 15, Day 29, Day 43 early termination |
|
|
|
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | 0.15 mg LY3493269 SC | Participants received 0.15 mg LY3493269 SC. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | 0.5 mg LY3493269 SC | Participants received 0.5 mg LY3493269 SC. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | 0.5 mg LY3493269 IV | Participants received 0.5 mg LY3493269 IV. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG004 | 1.5 mg LY3493269 SC | Participants received 1.5 mg LY3493269 SC. | 0 | 6 | 0 | 6 | 6 | 6 |
| Vision blurred | Eye disorders | MedDRA 22.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Catheter site bruise | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Catheter site phlebitis | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Early satiety | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Medical device site erosion | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Medical device site erythema | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 22.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Scratch | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA 22.1 | Systematic Assessment |
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| Appetite disorder | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
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| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Poor quality sleep | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
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