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| ID | Type | Description | Link |
|---|---|---|---|
| J1H-MC-LAJA | Other Identifier | Eli Lilly & Company |
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The study has two parts. In Part A, single increasing doses of LY3451838 will be administered intravenously (into a vein). In Part B, a single dose of LY3451838 will be administered subcutaneously (just under the skin).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25 milligram (mg) LY3451838 Part A | Experimental | 25 mg LY3451838 single dose administered intravenously (IV) |
|
| 75 mg LY3451838 Part A | Experimental | 75 mg LY3451838 single dose administered IV. |
|
| 250 mg LY3451838 Part A | Experimental | 250 mg LY3451838 single dose administered IV. |
|
| 500 mg LY3451838 Part A | Experimental | 500 mg LY3451838 single dose administered IV. |
|
| 1000 mg LY3451838 Part A | Experimental | 1000 mg LY3451838 single dose administered IV. |
|
| 1500 mg LY3451838 Part A | Experimental | 1500 mg LY3451838 single dose administered IV. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3451838 | Drug | Administered IV Part A |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Treatment Emergent Adverse Event | A summary of other non-serious Adverse Events (AE's), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section. | Baseline through 20 Weeks |
| Number of Participants With One or More Serious Adverse Events | A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Baseline through 20 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Serum Concentration-Time Curve From 0 to Infinity (AUC 0 -∞) of LY3451838 | PK: AUC of LY3451838 | Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose |
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Inclusion Criteria:
Male participants must adhere to contraception restrictions
Female participants must be of non-childbearing potential due to:
Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
Have clinical laboratory test results within normal reference range or with acceptable deviations
Have an estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute per 1.73 meters squared (mL/minute/1.73 m²) of body surface area
Have venous access sufficient to allow for blood sampling
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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40836866 | Derived | Johnson MP, Krikke-Workel J, Patel CN, Morin SM, Turner PK, Clark KA, Donley D, Jin Y, Johnson KW, Vincent M, Stille JR, Broad LM, Patel A. Preclinical and clinical evaluation of LY3451838, a PACAP-neutralizing monoclonal antibody, in randomized, double-blind, placebo-controlled phase 1 and phase 2 studies involving healthy adults and adults with treatment-resistant migraine. Cephalalgia. 2025 Aug;45(8):3331024251368757. doi: 10.1177/03331024251368757. Epub 2025 Aug 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 25 Milligram (mg) LY3451838 Part A | 25 mg LY3451838 single dose administered intravenously (IV) |
| FG001 | 75 mg LY3451838 Part A | 75 mg LY3451838 single dose administered IV. |
| FG002 | 250 mg LY3451838 Part A | 250 mg LY3451838 single dose administered IV. |
| FG003 | 500 mg LY3451838 Part A | 500 mg LY3451838 single dose administered IV. |
| FG004 | 1000 mg LY3451838 Part A | 1000 mg LY3451838 single dose administered IV. |
| FG005 | 1500 mg LY3451838 Part A | 1500 mg LY3451838 single dose administered IV. |
| FG006 | 250 mg LY3451838 Part B | 250 mg LY3451838 single dose administered subcutaneously (SC). |
| FG007 | Placebo | Placebo matching single dose administered IV in Part A and administered SC in Part B. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 25 Milligram (mg) LY3451838 Part A | 25 mg LY3451838 single dose administered intravenously (IV) |
| BG001 | 75 mg LY3451838 Part A | 75 mg LY3451838 single dose administered IV. |
| 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 Any Treatment Emergent Adverse Event | A summary of other non-serious Adverse Events (AE's), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through 20 Weeks |
|
Baseline up to 20 Weeks
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 | 25 mg LY3451838 Part A | 25 milligrams (mg) LY3451838 single dose administered Intravenously (IV). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear haemorrhage | Ear and labyrinth disorders | MedDRA 21.1 | 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 | Aug 13, 2019 | Sep 10, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2020 | Sep 10, 2025 | SAP_001.pdf |
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| 250 mg LY3451838 Part B | Experimental | 250 mg LY3451838 single dose administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Placebo matching single dose administered IV in Part A or administered SC in Part B. |
|
| LY3451838 |
| Drug |
Administered IV Part A |
|
| LY3451838 | Drug | Administered IV Part A |
|
| LY3451838 | Drug | Administered IV Part A |
|
| LY3451838 | Drug | Administered IV Part A |
|
| LY3451838 | Drug | Administered IV Part A |
|
| LY3451838 | Drug | Administered SC Part B |
|
| Placebo | Drug | Administered IV in Part A and SC in Part B |
|
| Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3451838 | PK: Cmax of LY3451838 | Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose |
| BG002 | 250 mg LY3451838 Part A | 250 mg LY3451838 single dose administered IV. |
| BG003 | 500 mg LY3451838 Part A | 500 mg LY3451838 single dose administered IV. |
| BG004 | 1000 mg LY3451838 Part A | 1000 mg LY3451838 single dose administered IV. |
| BG005 | 1500 mg LY3451838 Part A | 1500 mg LY3451838 single dose administered IV. |
| BG006 | 250 mg LY3451838 Part B | 250 mg LY3451838 single dose administered subcutaneously (SC). |
| BG007 | Placebo | Placebo matching single dose administered IV in Part A and administered SC in Part B. |
| BG008 | 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 |
| 250 mg LY3451838 Part A |
250 mg LY3451838 single dose administered IV. |
| OG003 | 500 mg LY3451838 Part A | 500 mg LY3451838 single dose administered IV. |
| OG004 | 1000 mg LY3451838 Part A | 1000 mg LY3451838 single dose administered IV. |
| OG005 | 1500 mg LY3451838 Part A | 1500 mg LY3451838 single dose administered IV. |
| OG006 | 250 mg LY3451838 Part B | 250 mg LY3451838 single dose administered subcutaneously (SC). |
| OG007 | Placebo | Placebo matching single dose administered IV in Part A and administered SC in Part B. |
|
|
| Primary | Number of Participants With One or More Serious Adverse Events | A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through 20 Weeks |
|
|
|
| Secondary | Pharmacokinetics (PK): Area Under the Serum Concentration-Time Curve From 0 to Infinity (AUC 0 -∞) of LY3451838 | PK: AUC of LY3451838 | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per milliliter (μg*h/mL) | Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3451838 | PK: Cmax of LY3451838 | All participants who received at least one dose of study drug and had evaluable PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | Part A: Predose, End of Infusion, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose; Part B: Predose, 3, 6, 12, 24, 36, 48 h, and Days 5, 7, 9, 15, 22, 29, 43, 57, 71, 85, and 141 post-dose |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| EG001 | 75 mg LY3451838 Part A | 75 mg LY3451838 single dose administered IV. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG002 | 250 mg LY3451838 Part A | 250 mg LY3451838 single dose administered IV. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG003 | 500 mg LY3451838 Part A | 500 mg LY3451838 single dose administered IV. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG004 | 1000 mg LY3451838 Part A | 1000 mg LY3451838 single dose administered IV. | 0 | 5 | 0 | 5 | 4 | 5 |
| EG005 | 1500 mg LY3451838 Part A | 1500 mg LY3451838 single dose administered IV. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG006 | 250 mg LY3451838 Part B | 250 mg LY3451838 or Placebo administered subcutaneously (SC). | 0 | 6 | 0 | 6 | 4 | 6 |
| EG007 | Placebo | Placebo administered IV in Part A and administered SC in Part B. | 0 | 14 | 0 | 14 | 12 | 14 |
| Motion sickness | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Application site erythema | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Catheter site bruise | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Catheter site paraesthesia | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Catheter site swelling | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Infusion site bruising | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Infusion site swelling | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vessel puncture site erythema | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA 21.1 | Systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Conjunctivitis viral | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal 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 |
|
| Productive cough | 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 |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
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