Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J1D-MC-GZAA | Other Identifier | Eli Lilly and Company |
Not provided
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Trial was terminated due to an insufficient benefit/tolerability ratio
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The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.
This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.01 Milligram (mg) LY3463251 Part A Cohort 1 | Experimental | Single dose of 0.01 mg LY3463251 administered subcutaneously (SC) on Day 1. |
|
| 0.03 mg LY3463251 Part A Cohort 2 | Experimental | Single dose of 0.03 mg LY3463251 administered SC on Day 1. |
|
| 0.1 mg LY3463251 Part A Cohort 3 | Experimental | Single dose of 0.1 mg LY3463251 administered SC on Day 1. |
|
| 0.3 mg LY3463251 Part A Cohort 4 | Experimental | Single dose of 0.3 mg LY3463251 administered SC on Day 1. |
|
| 1 mg LY3463251 Part A Cohort 5 | Experimental | Single dose of 1 mg LY3463251 administered SC on Day 1. |
|
| 3 mg LY3463251 Part A Cohort 6 | Experimental | Single dose of 3 mg LY3463251 administered SC on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3463251 | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With One or More Adverse Event(s) (AEs), All Causalities | A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A | PK: Cmax of LY3463251 | Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose |
| PK: Maximum Observed Concentration of LY3463251 Part B |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
| 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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36630958 | Derived | Benichou O, Coskun T, Gonciarz MD, Garhyan P, Adams AC, Du Y, Dunbar JD, Martin JA, Mather KJ, Pickard RT, Reynolds VL, Robins DA, Zvada SP, Emmerson PJ. Discovery, development, and clinical proof of mechanism of LY3463251, a long-acting GDF15 receptor agonist. Cell Metab. 2023 Feb 7;35(2):274-286.e10. doi: 10.1016/j.cmet.2022.12.011. Epub 2023 Jan 10. |
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Cohort 4 was terminated early because data from previous cohorts suggested a low probability of achieving competitive weight loss at tolerable doses.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Single Dose | Single dose of placebo administered subcutaneously (SC) on Day 1 |
| FG001 | 0.01 Milligram (mg) LY3463251 Part A Cohort 1 | Single dose of 0.01 mg LY3463251 administered SC on Day 1. |
| FG002 | 0.03 mg LY3463251 Part A Cohort 2 | Single dose of 0.03 mg LY3463251 administered SC on Day 1. |
| FG003 | 0.1 mg LY3463251 Part A Cohort 3 | Single dose of 0.1 mg LY3463251 administered SC on Day 1. |
| FG004 | 0.3 mg LY3463251 Part A Cohort 4 | Single dose of 0.3 mg LY3463251 administered SC on Day 1. |
| FG005 | 1 mg LY3463251 Part A Cohort 5 | Single dose of 1 mg LY3463251 administered SC on Day 1. |
| FG006 | 3 mg LY3463251 Part A Cohort 6 | Single dose of 3 mg LY3463251 administered SC on Day 1. |
| FG007 | 10 mg LY3463251 Part A Cohort 7 | Single dose of 10 mg LY3463251 administered SC on Day 1. |
| FG008 | 24 mg LY3463251 Part A Cohort 8 | Single dose of 24 mg LY3463251 administered SC on Day 1. |
| FG009 | Placebo Multiple Dose | Placebo administered SC, once weekly (QW) on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| FG010 | 1 mg LY3463251 Part B Cohort 1 | 1 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| FG011 | 3 mg LY3465231 Part B Cohort 2 | 3 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| FG012 | 3/6/9 mg LY3463251 Part B Cohort 3 | 3 mg LY3463251 administered SC QW on Days 1 and 8. 6 mg LY3463251 administered SC QW on Days 15 and 22. 9 mg LY3463251 administered SC QW on Days 29. 36, 43, 50, 57, 64, 71, and 78. |
| FG013 | 3/9/15/24 mg LY3463251 Part B Cohort 4 | 3 mg LY3463251 administered SC QW on Days 1 and 8. 9 mg LY3463251 administered SC QW on Days 15 and 22. 15 mg LY3463251 administered SC QW on Days 29 and 36. 24 mg LY3463251 administered SC QW on Days 43, 50, 57, 64, 71, and 78. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants, whether or not they completed all protocol requirements.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Single Dose | Single dose of placebo administered SC on Day 1 |
| BG001 | 0.01 Milligram (mg) LY3463251 Part A Cohort 1 | Single dose of 0.01 mg LY3463251 administered SC on Day 1. |
| 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 Adverse Event(s) (AEs), All Causalities | A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | All enrolled participants, whether or not they completed all protocol requirements. | Posted | Count of Participants | Participants | No | Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123) |
|
Part A: Baseline up to 42 days Part B: Baseline up to 123 days
All enrolled participants whether or not they completed all protocol requirements.
Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thyroid mass | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
Cohort 4 was terminated early because data from previous cohorts suggested a low probability of achieving competitive weight loss at tolerable doses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2020 | Sep 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2021 | Sep 10, 2021 | SAP_001.pdf |
Not provided
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|
| 10 mg LY3463251 Part A Cohort 7 | Experimental | Single dose of 10 mg LY3463251 administered SC on Day 1. |
|
| 24 mg LY3463251 Part A Cohort 8 | Experimental | Single dose of 24 mg LY3463251 administered SC on Day 1. |
|
| Placebo Single Dose | Placebo Comparator | Single dose of placebo administered SC. |
|
| 1 mg LY3463251 Part B Cohort 1 | Experimental | 1 mg LY3463251 administered SC, once weekly (QW) for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
|
| 3 mg LY3465231 Part B Cohort 2 | Experimental | 3 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
|
| 3/6/9 mg LY3463251 Part B Cohort 3 | Experimental | 3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78. |
|
| 3/9/15/24 mg LY3463251 Part B Cohort | Experimental | 3 mg LY3463251 administered SC, QW on Days 1 and 8. 9 mg LY3463251 administered SC, QW on Days 15 and 22. 15 mg LY3463251 administered SC, QW on Days 29 and 36. 24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78. |
|
| Placebo Multiple Dose | Placebo Comparator | Placebo administered SC, QW for 12 weeks. |
|
| Placebo | Drug | Administered SC |
|
PK: Cmax of LY3463251 |
| Day 1: Predose, 6, 12, 24, 48, 72, and 120 hours (hr) postdose; Day 8: Predose; Day 15: Predose; Day 28: Predose; Day 57: Predose; Day 78: Predose, and Day 79: 24 hr postdose |
| PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A | PK: AUC versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LY3463251. | Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose |
| PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part B | PK: AUC(0-tau) of LY3463251 during one dosing interval on Day 1 and Day 78. | Day 1: Predose, 6, 12, 24, 48, 72, 120, and 168 hours (hr) postdose: Day 78: Predose, 24, 48, 168, 336, 696, 1080 hr postdose |
| Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part B | AUC of glucose was analyzed using a model with treatment + Day + Treatment*Day + Subject + Random Error where Subject is fitted as a random effect and a repeated statement used with an Unstructured covariance structure. | PD: Day -2; Predose: Day 30 and Day 85 (Part B) |
| Change From Baseline in Body Weight at Day 85 Part B | Change from Baseline in Body Weight | Baseline, Day 85 (Part B) |
| Adverse Event |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Study Termination |
|
| BG002 | 0.03 mg LY3463251 Part A Cohort 2 | Single dose of 0.03 mg LY3463251 administered SC on Day 1. |
| BG003 | 0.1 mg LY3463251 Part A Cohort 3 | Single dose of 0.1 mg LY3463251 administered SC on Day 1. |
| BG004 | 0.3 mg LY3463251 Part A Cohort 4 | Single dose of 0.3 mg LY3463251 administered SC on Day 1. |
| BG005 | 1 mg LY3463251 Part A Cohort 5 | Single dose of 1 mg LY3463251 administered SC on Day 1. |
| BG006 | 3 mg LY3463251 Part A Cohort 6 | Single dose of 3 mg LY3463251 administered SC on Day 1. |
| BG007 | 10 mg LY3463251 Part A Cohort 7 | Single dose of 10 mg LY3463251 administered SC on Day 1. |
| BG008 | 24 mg LY3463251 Part A Cohort 8 | Single dose of 24 mg LY3463251 administered SC on Day 1. |
| BG009 | Placebo Multiple Dose | Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| BG010 | 1 mg LY3463251 Part B Cohort 1 | 1 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| BG011 | 3 mg LY3465231 Part B Cohort 2 | 3 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| BG012 | 3/6/9 mg LY3463251 Part B Cohort 3 | 3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78. |
| BG013 | 3/9/15/24 mg LY3463251 Part B Cohort 4 | 3 mg LY3463251 administered SC, QW on Days 1 and 8. 9 mg LY3463251 administered SC, QW on Days 15 and 22. 15 mg LY3463251 administered SC, QW on Days 29 and 36. 24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78. |
| BG014 | 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 |
|
| OG002 | 0.03 mg LY3463251 Part A Cohort 2 | Single dose of 0.03 mg LY3463251 administered SC on Day 1. |
| OG003 | 0.1 mg LY3463251 Part A Cohort 3 | Single dose of 0.1 mg LY3463251 administered SC on Day 1. |
| OG004 | 0.3 mg LY3463251 Part A Cohort 4 | Single dose of 0.3 mg LY3463251 administered SC on Day 1. |
| OG005 | 1 mg LY3463251 Part A Cohort 5 | Single dose of 1 mg LY3463251 administered SC on Day 1. |
| OG006 | 3 mg LY3463251 Part A Cohort 6 | Single dose of 3 mg LY3463251 administered SC on Day 1. |
| OG007 | 10 mg LY3463251 Part A Cohort 7 | Single dose of 10 mg LY3463251 administered SC on Day 1. |
| OG008 | 24 mg LY3463251 Part A Cohort 8 | Single dose of 24 mg LY3463251 administered SC on Day 1. |
| OG009 | Placebo Multiple Dose | Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| OG010 | 1 mg LY3463251 Part B Cohort 1 | 1 mg LY3463251 administered SC, QW for 12 weeks on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| OG011 | 3 mg LY3465231 Part B Cohort 2 | 3 mg LY3463251 administered SC, QW for 12 weeks Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| OG012 | 3/6/9 mg LY3463251 Part B Cohort 3 | 3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78. |
| OG013 | 3/9/15/24 mg LY3463251 Part B Cohort 4 | 3 mg LY3463251 administered SC, QW on Days 1 and 8. 9 mg LY3463251 administered SC, QW on Days 15 and 22. 15 mg LY3463251 administered SC, QW on Days 29 and 36. 24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78. |
|
|
| Secondary | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A | PK: Cmax of LY3463251 | All participants who received at least one dose of LY3463251 and had evaluable PK data in Part A. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose |
|
|
|
| Secondary | PK: Maximum Observed Concentration of LY3463251 Part B | PK: Cmax of LY3463251 | All participants who received at least one dose of LY3463251 and had evaluable PK in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 78). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 6, 12, 24, 48, 72, and 120 hours (hr) postdose; Day 8: Predose; Day 15: Predose; Day 28: Predose; Day 57: Predose; Day 78: Predose, and Day 79: 24 hr postdose |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A | PK: AUC versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LY3463251. | All participants who received at least one dose of LY3463251 and had evaluable PK data in Part A. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram * hour per milliliter (ng*h/mL) | Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose |
|
|
|
| Secondary | PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part B | PK: AUC(0-tau) of LY3463251 during one dosing interval on Day 1 and Day 78. | All participants who received at least one dose of LY3463251 and had evaluable PK data in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 78). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Day 1: Predose, 6, 12, 24, 48, 72, 120, and 168 hours (hr) postdose: Day 78: Predose, 24, 48, 168, 336, 696, 1080 hr postdose |
|
|
|
| Secondary | Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part B | AUC of glucose was analyzed using a model with treatment + Day + Treatment*Day + Subject + Random Error where Subject is fitted as a random effect and a repeated statement used with an Unstructured covariance structure. | All participants who received at least one dose of LY3463251 and had evaluable PD data in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 85). | Posted | Mean | Standard Deviation | millimole*hour per Liter (mmol*h/L) | PD: Day -2; Predose: Day 30 and Day 85 (Part B) |
|
|
|
| Secondary | Change From Baseline in Body Weight at Day 85 Part B | Change from Baseline in Body Weight | All participants who received at least one dose of LY3463251 and had evaluable PD data in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 85). | Posted | Mean | Standard Deviation | kilograms (kg) | Baseline, Day 85 (Part B) |
|
|
|
| 16 |
| 0 |
| 16 |
| 1 |
| 16 |
| EG001 | 0.01 mg LY3463251 | 0.01 mg LY3463251 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | 0.03 mg LY3463251 | 0.03 mg LY3463251 | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | 0.1 mg LY3463251 | 0.1 mg LY3463251 | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | 0.3 mg LY3463251 | 0.3 mg LY3463251 | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | 1 mg LY3463251 | 1 mg LY3463251 | 0 | 6 | 0 | 6 | 2 | 6 |
| EG006 | 3 mg LY3463251 | 3 mg LY3463251 | 0 | 6 | 0 | 6 | 1 | 6 |
| EG007 | 10 mg LY3463251 | 10 mg LY3463251 | 0 | 6 | 0 | 6 | 6 | 6 |
| EG008 | 24 mg LY3463251 | 24 mg LY3463251 | 0 | 6 | 0 | 6 | 6 | 6 |
| EG009 | Placebo QW | Placebo QW | 0 | 13 | 0 | 13 | 5 | 13 |
| EG010 | 1 mg LY3463251 QW | 1 mg LY3463251 QW | 0 | 10 | 0 | 10 | 5 | 10 |
| EG011 | 3 mg LY3463251 QW | 3 mg LY3463251 QW | 0 | 10 | 0 | 10 | 5 | 10 |
| EG012 | 3/6/9 mg LY3463251 QW | 3/6/9 mg LY3463251 QW | 0 | 18 | 0 | 18 | 13 | 18 |
| EG013 | 3/9/15/24 mg LY3463251 QW | 3/9/15/24 mg LY3463251 QW | 0 | 3 | 0 | 3 | 3 | 3 |
| Periorbital swelling | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hunger | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 21.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Aura | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Urine abnormality | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
Not provided
|
| Day 78 |
|
|
|
| Day 78 |
|
|
|
| Day 30 |
|
|
| Day 85 |
|
|