A Randomized, Placebo-Controlled, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Galcanezumab in Healthy Chinese Subjects
Phase: PHASE1
Conditions: Healthy
Sponsor: Eli Lilly and Company

Protocol I5Q-MC-CGAY(a) 
 
 
A Randomized, Placebo-Controlled, Single-Dose Study to Assess the Pharmacokinetics, Safety, 
and Tolerability of Galcanezumab in Healthy Chinese Subjects  
 
 
NCT04085289  
 
 
Approval Date: 09-Apr-2019 

I5Q-MC-CGAY(a) Clinical Pharmacology Protocol
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Galcanezumab (LY2951742)
Protocol I5Q-MC-CGAY(a)
A Randomized, Placebo-Controlled, Single-Dose Study to 
Assess the Pharmacokinetics, Safety, and Tolerability of 
Galcanezumab in Healthy Chinese Subjects
Confidential Information
The information contained in this protocol is confidential and is intended for the use of 
clinical investigators.  It is the property of Eli Lilly and Company or its subsidiaries and 
should not be copied by or distributed to persons not involved in the clinical investigation of 
galcanezumab (LY2951742), unless such persons are bound by a confidentiality 
agreement with Eli Lilly and Company or its subsidiaries.
Note to Regulatory Authorities:  This document may contain protected personal data 
and/or commercially confidential information exempt from public disclosure.  Eli Lilly and 
Company requests consultation regarding release/redaction prior to any public release.  In 
the United States, this document is subject to Freedom of Information Act (FOIA) 
Exemption 4 and may not be reproduced or otherwise disseminated without the written 
approval of Eli Lilly and Company or its subsidiaries.
Galcanezumab (LY2951742)
Eli Lilly and Company
Indianapolis, Indiana USA 46285
Clinical Pharmacology Protocol Approved on:  28 Jun 2018
Amendment (a) Electronically Signed and Approved by Lilly on date provided below.
Approval Date: 09-Apr-2019 GMT

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Galcanezumab (LY2951742)
Table of Contents
A Randomized, Placebo-Controlled, Single-Dose Study to 
Assess the Pharmacokinetics, Safety, and Tolerability of 
Galcanezumab in Healthy Chinese Subjects
Section
Page
Protocol I5Q-MC-CGAY(a) A Randomized, Placebo-Controlled, 
Single-Dose Study to Assess the Pharmacokinetics, Safety, and 
Tolerability of Galcanezumab in Healthy Chinese Subjects.................................................1
Table of Contents........................................................................................................................2
1.
Protocol Synopsis................................................................................................................7
2.
Schedule of Activities .........................................................................................................9
3.
Introduction ......................................................................................................................12
3.1.
Study Rationale............................................................................................................12
3.2.
Background..................................................................................................................12
3.2.1.
Clinical Experience with Galcanezumab ..............................................................12
3.2.1.1.
Clinical Pharmacokinetic Data........................................................................12
3.2.1.2.
Clinical Safety Data........................................................................................13
3.3.
Benefit/Risk Assessment..............................................................................................13
4.
Objectives and Endpoints..................................................................................................15
5.
Study Design.....................................................................................................................16
5.1.
Overall Design .............................................................................................................16
5.2.
Number of Participants.................................................................................................16
5.3.
End of Study Definition ...............................................................................................16
5.4.
Scientific Rationale for Study Design...........................................................................16
5.5.
Justification for Dose ...................................................................................................17
6.
Study Population...............................................................................................................18
6.1.
Inclusion Criteria..........................................................................................................18
6.2.
Exclusion Criteria ........................................................................................................19
6.2.1.
Rationale for Exclusion of Certain Study Candidates ...........................................21
6.3.
Lifestyle and/or Dietary Requirements .........................................................................21
6.3.1.
Meals and Dietary Restrictions.............................................................................21
6.3.2.
Caffeine, Alcohol, and Tobacco ...........................................................................21
6.3.3.
Activity................................................................................................................21
6.3.4.
Contraception.......................................................................................................21
6.3.5.
Blood or Plasma Donations ..................................................................................21

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Galcanezumab (LY2951742)
6.4.
Screen Failures.............................................................................................................22
7.
Treatment..........................................................................................................................23
7.1.
Treatment Administered...............................................................................................23
7.1.1.
Packaging and Labeling .......................................................................................23
7.2.
Method of Treatment Assignment ................................................................................24
7.2.1.
Selection and Timing of Doses.............................................................................24
7.3.
Blinding .......................................................................................................................24
7.4.
Dose Modification........................................................................................................24
7.5.
Preparation/Handling/Storage/Accountability...............................................................24
7.6.
Treatment Compliance .................................................................................................25
7.7.
Concomitant Therapy...................................................................................................25
7.8.
Treatment after the End of the Study............................................................................25
8.
Discontinuation Criteria ....................................................................................................26
8.1.
Discontinuation from Study Treatment.........................................................................26
8.1.1.
Discontinuation of Inadvertently Enrolled Subjects..............................................26
8.2.
Discontinuation from the Study....................................................................................26
8.3.
Subjects Lost to Follow-up...........................................................................................26
9.
Study Assessments and Procedures ...................................................................................27
9.1.
Efficacy Assessments...................................................................................................27
9.2.
Adverse Events ............................................................................................................27
9.2.1.
Serious Adverse Events........................................................................................28
9.2.1.1.
Suspected Unexpected Serious Adverse Reactions..........................................28
9.2.2.
Complaint Handling.............................................................................................29
9.3.
Treatment of Overdose.................................................................................................29
9.4.
Pharmacokinetics .........................................................................................................29
9.4.1.
Bioanalysis...........................................................................................................29
9.5.
Safety...........................................................................................................................29
9.5.1.
Laboratory Tests ..................................................................................................29
9.5.2.
Vital Signs ...........................................................................................................30
9.5.3.
Electrocardiograms ..............................................................................................30
9.5.4.
Injection Site Assessments ...................................................................................30
9.5.5.
Physical Examination...........................................................................................30
9.5.6.
Body Weight........................................................................................................31
9.5.7.
Tuberculosis Testing ............................................................................................31
9.5.8.
Safety Monitoring ................................................................................................31
9.6.
Pharmacodynamics ......................................................................................................31
9.6.1.
Immunogenicity Assessments ..............................................................................31
9.7.
Genetics .......................................................................................................................32

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Galcanezumab (LY2951742)
9.8.
Biomarkers...................................................................................................................32
9.9.
Health Economics ........................................................................................................32
10.
Statistical Considerations and Data Analysis.....................................................................33
10.1. Sample Size Determination ..........................................................................................33
10.2. Populations for Analyses..............................................................................................33
10.2.1.
Study Participant Disposition ...............................................................................33
10.2.2.
Study Participant Characteristics ..........................................................................33
10.3. Statistical Analyses ......................................................................................................33
10.3.1.
Pharmacokinetic Analyses....................................................................................33
10.3.1.1.
Pharmacokinetic Parameter Estimation...........................................................33
10.3.1.2.
Pharmacokinetic Statistical Inference .............................................................34
10.3.2.
Safety Analyses....................................................................................................34
10.3.2.1.
Clinical Evaluation of Safety..........................................................................34
10.3.2.2.
Statistical Evaluation of Safety.......................................................................34
10.3.3.
Evaluation of Immunogenicity .............................................................................34
10.3.4.
Interim Analyses..................................................................................................34
11.
References ........................................................................................................................35

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Galcanezumab (LY2951742)
List of Tables
Table
Page
Table CGAY.1.
Objectives and Endpoints .......................................................................15
Table CGAY.2.
Treatments Administered........................................................................23
Table CGAY.3.
Amendment Summary for Protocol I5Q-MC-CGAY 
Amendment(a)........................................................................................45

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Galcanezumab (LY2951742)
List of Appendices
Appendix
Page
Appendix 1.
Abbreviations and Definitions ................................................................36
Appendix 2.
Clinical Laboratory Tests........................................................................40
Appendix 3.
Study Governance, Regulatory and Ethical Considerations.....................41
Appendix 4.
Blood Sampling Summary......................................................................44
Appendix 5.
Protocol Amendment I5Q-MC-CGAY(a) Summary A 
Randomized, Placebo-Controlled, Single-Dose Study to Assess the 
Pharmacokinetics, Safety, and Tolerability of Galcanezumab in 
Healthy Chinese Subjects .......................................................................45

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Galcanezumab (LY2951742)
1. Protocol Synopsis
Title of Study:
A Randomized, Placebo-Controlled, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of 
Galcanezumab in Healthy Chinese Subjects.
Rationale: 
Galcanezumab is a humanized monoclonal antibody being developed for migraine prophylaxis. This is a study of 
galcanezumab in Chinese subjects and the results will be used to support registration for this indication in China.
Objective(s)/Endpoints:  
Objectives
Endpoints
Primary
To investigate the pharmacokinetics (PK) of 
galcanezumab following a single subcutaneous (SC)
administration of galcanezumab to healthy Chinese 
subjects.
Cmax and area under the concentration versus time 
curve from time zero to infinity (AUC[0-∞]) of 
galcanezumab.
Secondary
To investigate the safety and tolerability of a single SC 
administration of galcanezumab to healthy Chinese 
subjects.
Incidence of adverse events (AEs) and serious AEs.
Summary of Study Design:
Study I5Q-MC-CGAY is a single-center, randomized, subject- and investigator-blind, placebo-controlled, 
parallel-group, single-dose study in healthy Chinese subjects.  Healthy males and females, as determined by medical 
history, physical examination, vital signs, clinical laboratory tests, and electrocardiograms, will be enrolled.  
Subjects are to be native Chinese, at least 18 years of age, with a body mass index between 18.5 and 35.0 kg/m2,
inclusive, at screening.  Females must test negative for pregnancy and females of childbearing potential must agree 
to use a reliable method of contraception during the study and for 5 months after dosing.  Subjects will be excluded 
if they have allergies to either monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone  
Treatment Arms and Planned Duration for an Individual Subject:  
Each subject will have a screening visit within 28 days prior to dosing.  Subjects will be randomized within a cohort 
to receive galcanezumab or placebo:  Subjects in Cohort A will receive a single dose of 120 mg galcanezumab or 
placebo; Cohort B will receive a single dose of 240 mg galcanezumab or placebo.  Dosing of cohorts may be 
conducted in parallel or sequentially at the discretion of the Investigator.
Subjects will be admitted to the clinical research unit on Day -1 and may be discharged after all assessments have 
been completed on Day 3.  Subjects may remain inpatient up to Day 15 to improve visit compliance, at the 
discretion of the investigator.  A single SC dose of galcanezumab or placebo will be administered according to 

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Galcanezumab (LY2951742)
randomization on the morning of Day 1.  Subjects will return for outpatient visits for up to 5 months after dosing for 
safety, tolerability, immunogenicity, and PK assessments.
Number of Subjects:
Approximately 30 subjects may be enrolled in this study to adjust for any discontinuations and try to ensure that 
approximately 20 subjects complete the study (10 per cohort; 8 galcanezumab and 2 placebo).  The sample size is 
customary for Phase 1 studies evaluating safety, tolerability, and PK, and is not powered on the basis of statistical 
hypothesis testing.
Statistical Analysis:
There will be no formal statistical analyses.  The PK, safety, tolerability, and immunogenicity data will be 
summarized using standard descriptive statistics, as appropriate.

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Galcanezumab (LY2951742)
2. Schedule of Activities

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Galcanezumab (LY2951742)
Study Schedule Protocol I5Q-MC-CGAY
Week
0
1
2
3
4
6
8
10
12
16
20
Daya
SCRb
- 1
1
2
3
5
6
8
10
12
15
22
29
43
57
71
85
113
141c
Visit Window (days)
㼼1
㼼2
㼼2
㼼3
㼼3
㼼3
㼼3
㼼3
㼼3
CRU admission/visitsd
X
Inpatient stay
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Randomization
X
Study drug injection
Xe
Informed Consent
X
Eligibility assessment
X
Medical history
X
Recording of AEsf
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Concomitant medication
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Physical examg
X
X
Predose
X
X
X
X
X
X
X
X
Body temperature
X
Height, weighth
X
Predose
X
Vital signs (hours)i
X
Predose, 
8
24
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Single 12-lead ECG (hours)
X
X
24
X
X (ED only)
Clinical Laboratory tests
X
X
Predose
X
X
X
X (ED only)
Serology:  HIV, HBV, HCV
X
Urine drug screen, ethanol 
breath testj
X
X
Chest x-ray and T-SPOT test
X
Pregnancy testk
X
X
X
Galcanezumab PK blood 
sampling (hours)l
8
24
48
96
120
168
216
264
336
504
672
1008
1344
1680
2016
2688
3360
PGx blood sampling
Predose
Immunogenicity blood 
samplingm
Predose
X
X
X
X
X

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Galcanezumab (LY2951742)
Abbreviations:  AE = adverse event; CRU = clinical research unit; ECG = electrocardiogram; ED = early discontinuation; HBV = hepatitis B virus; 
HCV = hepatitis C virus; HIV = human immunodeficiency virus; PK = pharmacokinetics; PGx = pharmacogenetics; SCR = screening; T-SPOT = T-SPOT®
tuberculosis test.
a
If these procedures cannot be done on the same day, they should be done at closest time possible. 
b
Screening evaluations to be performed within 28 days prior to dosing.
c
Also procedures for early discontinuation.
d
Subjects will be admitted to the CRU on Day -1, and may be discharged on Day 3 after the procedures scheduled at 48 hours after dosing have been 
completed.  Subjects may remain inpatient up to Day 15 to improve visit compliance, at the discretion of the investigator.  Unless specified, safety monitoring 
procedures should be done close to the dosing time on Day 1, except for screening and the day before dosing.
e
Per randomization scheme.  Where possible, subjects to stay in the semi-recumbent position for 4 hours following study drug administration.
f
The investigator will record additional details regarding AEs related to injection sites and hypersensitivity events.
g
Complete physical examination to be performed at screening and at the final visit for each subject; symptom-directed physical examination only at other visits 
and as clinically indicated.
h
Height to be measured at screening only.
i
Vital signs include sitting blood pressure and pulse rate.
j
Additional urine drug screen and breath ethanol tests may be performed at the investigator’s discretion.
k
Females only.  Blood pregnancy test will be done on screening; urine test at other times as indicated, or when performed at the investigator’s discretion.
l
It is preferred that on days without dosing the PK samples should be taken close to the Day 1 dosing time.  Nominal PK sampling times are given as targets to 
be achieved within reasonable limits. Additional samples may be taken (see Section 9.6.1). 
m Additional samples may be taken (see Section 9.6.1). 

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Galcanezumab (LY2951742)
3. Introduction
3.1.
Study Rationale
This is a study of galcanezumab in Chinese subjects.  The main purpose of this study is to 
evaluate the pharmacokinetics (PK), safety, and tolerability of galcanezumab in healthy Chinese 
subjects.  The results from this study will be used to support registration for migraine 
prophylaxis in China.  
3.2.
Background
Galcanezumab (LY2951742) is a humanized monoclonal antibody that binds to calcitonin 
gene-related peptide (CGRP), a peptide that is widely expressed in the central and peripheral 
nervous system and acts as a local facilitator of inflammatory processes. Lilly is currently 
evaluating galcanezumab for the prophylaxis of migraine and cluster headache.
3.2.1. Clinical Experience with Galcanezumab
Four clinical pharmacology studies with galcanezumab have been completed to date in healthy 
subjects.  The subject population included 446 healthy subjects of whom 419 subjects received at 
least 1 dose of galcanezumab (dose range 1 to 600 mg).
Two Phase 2 studies and the double-blinded phase of three Phase 3 studies in migraine patients 
have completed, and demonstrated consistent efficacy in migraine prevention.  The treatment 
phase of a further Phase 3 open-label study in migraine patients has also completed. Additional 
Phase 3 studies in migraine patients are ongoing, including 2 studies conducted in Japanese 
patients. In the completed Phase 2 studies, a total of 380 migraine patients received repeated 
doses of galcanezumab; 150 mg every 2 weeks in 1 study, or 5 to 300 mg every 4 weeks in the 
other.  In the completed Phase 3 studies, safety and efficacy of galcanezumab were tested in 
migraine patients who received either placebo or galcanezumab at doses of 120 mg monthly,
after a 240 mg loading dose, or 240 mg monthly. Safety and efficacy profiles of both doses were 
comparable.
In September 2018, galcanezumab (Emgality™) was approved in the US for the prevention of 
migraine in adults.  Additionally, galcanezumab was approved in the EU in November 2018, for 
the prophylaxis of migraine in adults who have at least 4 migraine days per month.  The 
approved dose of galcanezumab is a loading dose of 240 mg followed by monthly doses of 
120 mg.
In addition to migraine prevention, safety and efficacy of galcanezumab were also tested in 
2 completed Phase 3 studies in patients with episodic and chronic cluster headache at 300 mg 
monthly dose.
3.2.1.1.
Clinical Pharmacokinetic Data
Galcanezumab exhibited PK properties consistent with an immunoglobulin G monoclonal 
antibody. Based on population PK analysis, the apparent clearance of galcanezumab was 
approximately 0.008 L/h (34% inter-individual variability), the half-life associated with the 
terminal elimination phase (t1/2) was 27 days and the mean maximum observed drug

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Galcanezumab (LY2951742)
concentration (Cmax) is expected to be achieved by 5 to 7 days after subcutaneous 
administration.  Galcanezumab exposure increases proportionally with dose.  Race is not a 
statistically significant covariate of galcanezumab PK.  
3.2.1.2.
Clinical Safety Data
Two serious adverse events (SAEs) were reported in subjects who received galcanezumab during 
the clinical pharmacology program:  a death due to drowning, which was not considered by the 
investigator to be related to investigational product and atrial fibrillation, which was considered 
to be possibly related to investigational product.  Other than the subject who died, no subjects 
discontinued from any clinical pharmacology study because of an adverse event (AE).
In the clinical pharmacology program, the incidences of common treatment-emergent adverse 
events (TEAEs), including headache, injection site erythema, injection site pain, and upper 
respiratory tract infection, were similar to those of subjects who received at least 1 dose of 
placebo, and frequency did not appear dose dependent.  A low frequency (1%) of TEAEs related 
to cardiovascular safety occurred in subjects who received at least 1 dose of galcanezumab, and 
none occurred in subjects who received placebo.  No consistent blood pressure, heart rate, or 
electrocardiogram (ECG) findings were observed across treatment groups, including placebo.
There were no reports of TEAEs related to suicidal ideation and behavior.
In an integrated analysis of data from all 6 ongoing or completed migraine patient studies, 67.0%
of patients in the galcanezumab-pooled dose group reported at least one TEAE.  The common 
TEAEs (reported by ≥1.5% of patients before rounding) in this group included injection site 
pain, nasopharyngitis, upper respiratory tract infection, and injection site reaction (ISR).  A total 
of 81 patients (3.1%) in the galcanezumab-pooled dose group discontinued due to AEs.  Those 
AEs that led to discontinuation in >2 patients in this group were:  ISR, migraine, urticaria, 
injection site erythema, and rash.  Serious hypersensitivity cases of urticaria have been reported 
in migraine patients receiving galcanezumab; non-serious adverse drug reactions included ISR, 
vertigo, constipation, and pruritus.
Nine of 160 subjects developed treatment-emergent antidrug antibody after a single dose of 
240 mg galcanezumab solution in a clinical pharmacology study. Overall, the presence of 
antidrug antibodies (ADAs) did not affect the PK, efficacy, or safety of galcanezumab.
Aggregate findings from healthy subjects and patients who developed treatment-emergent ADA
did not reveal a relationship between injection site reactions or hypersensitivity reactions and 
immunogenicity
More information about the known and expected benefits, risks and reasonably anticipated AEs 
may be found in the Investigator’s Brochure (IB).  Information on AEs expected to be related to 
the investigational product may be found in Section 7 (Development Core Safety Information) of 
the IB.
3.3.
Benefit/Risk Assessment
This study will evaluate single doses of 120 and 240 mg galcanezumab.  The justification of 
these doses can be found in Section 5.5.  No clinically significant safety or tolerability concerns 

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Galcanezumab (LY2951742)
have been identified in subjects to date for galcanezumab up to the highest single dose given 
(600 mg). In this study, there is no anticipated therapeutic benefit for the subjects.  Potential 
risks include but are not limited to hypersensitivity reactions.  The risk profile of galcanezumab
remains supportive of further clinical development. 
More information about the known and expected benefits, risks, SAEs and reasonably 
anticipated AEs of galcanezumab are to be found in the IB.  

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Galcanezumab (LY2951742)
4. Objectives and Endpoints
Table CGAY.1 shows the objectives and endpoints of the study.
Table CGAY.1.
Objectives and Endpoints
Objectives
Endpoints
Primary
To investigate the PK of galcanezumab following a 
single SC administration of galcanezumab to healthy
Chinese subjects.  
Cmax and area under the concentration versus time 
curve from time zero to infinity (AUC[0-∞]) of 
galcanezumab.
Secondary
To investigate the safety and tolerability of a single SC 
administration of galcanezumab to healthy Chinese 
subjects.
Incidence of AEs and SAEs.
Exploratory
To evaluate galcanezumab with respect to 
immunogenicity in healthy Chinese subjects.  
Development of ADAs to galcanezumab.

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Galcanezumab (LY2951742)
5. Study Design
5.1.
Overall Design
This is a Phase 1, single-center, randomized, subject- and investigator-blind, placebo-controlled, 
parallel-group, single-dose study in healthy Chinese subjects.  Subjects will be assigned to 1 of 
2 cohorts and randomized to receive galcanezumab or placebo (4:1 ratio), as described in 
Section 7.2.  Subjects will receive the following treatments:

Cohort A: a single dose of 120 mg galcanezumab or placebo

Cohort B:  a single dose of 240 mg galcanezumab or placebo
Dosing of cohorts may be conducted in parallel or sequentially at the discretion of the 
Investigator.
Subjects will be admitted to the clinical research unit (CRU) on Day -1 and may be discharged 
after all assessments have been completed on Day 3.  Subjects may remain inpatient up to Day 
15 to improve visit compliance, at the discretion of the investigator.  A single SC dose of 
galcanezumab or placebo will be administered according to randomization on the morning of 
Day 1.  Subjects will return for outpatient visits for up to 5 months after dosing for safety, 
tolerability, immunogenicity, and PK assessments.  
Safety and tolerability will be assessed throughout the study by means of vital sign 
measurements, clinical laboratory tests, ECG, physical examinations (as indicated), and AE 
recording.
Study governance considerations are described in detail in Appendix 3.
5.2.
Number of Participants
Approximately 30 subjects may be enrolled to ensure that approximately 20 subjects complete 
the study.  Up to 15 subjects will be enrolled in each of 2 cohorts and randomized to receive 
either galcanezumab or placebo (4:1 ratio), to ensure that approximately 8 subjects receiving 
galcanezumab and 2 subjects receiving placebo complete each cohort.  For purposes of this 
study, a subject will be considered to have completed the study when they complete the
follow-up procedures at approximately 20 weeks, as shown in the Schedule of Activities 
(Section 2).
5.3.
End of Study Definition
End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of 
Activities (Section 2) for the last subject.
5.4.
Scientific Rationale for Study Design
The subject- and investigator-blinded, randomized, placebo-controlled design minimizes bias on 
safety and tolerability assessments, and allows a more robust comparison among galcanezumab 
and placebo doses.  

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Galcanezumab (LY2951742)
The selection of healthy subjects is appropriate and in keeping with standard regional practices 
for clinical pharmacology studies.  The inclusion and exclusion criteria are chosen to select 
subjects who are known to be free from any significant illness and from any condition that could 
affect their safety or interfere with meeting the study objectives.  
The approximately 20-week PK sampling is based on clinical PK data for galcanezumab 
following administration of single doses of up to 600-mg to healthy subjects (t1/2 was 27 days).  
Based upon the available clinical PK data for galcanezumab, the duration of this study is
adequate to achieve the study objectives.
5.5.
Justification for Dose
Galcanezumab 120 mg and 240 mg were selected for this study because these doses were 
evaluated in the Phase 3 China registration trials for the treatment of migraine prophylaxis.

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Galcanezumab (LY2951742)
6. Study Population
Eligibility of subjects for the study will be based on the results of screening medical history, 
physical examination, vital signs, clinical laboratory tests and ECG. 
The nature of any conditions present at the time of the physical examination and any preexisting 
conditions will be documented.
Screening may occur up to 28 days prior to dosing.  Subjects who are not dosed within 28 days 
of screening may be subjected to an additional medical assessment and/or clinical measurements 
to confirm their eligibility.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, are not permitted.
6.1.
Inclusion Criteria
Subjects are eligible for inclusion in the study only if they meet all of the following criteria at 
screening and/or admission:
[1]
are native Chinese (all 4 biological grandparents and both biological parents 
to be of Chinese origin)
[2]
are overtly healthy males or females, as determined by medical history and 
physical examination  
[2a] female subjects:
All females must test negative for pregnancy at the time of enrollment based 
on a serum pregnancy test and females of childbearing potential must agree to 
use a reliable method of birth control during the study as well as for 5 months 
after dosing.  Acceptable methods of birth control for this study include oral
contraceptives, implantable contraceptives, injectable contraceptives, a 
contraceptive patch, barrier methods (such as diaphragms with contraceptive 
jelly, cervical caps with contraceptive jelly, condoms with contraceptive 
foam, or intrauterine devices), or a partner with vasectomy.  Birth control is 
not required if the female is infertile due to surgical sterilization 
(hysterectomy, or at least 6 weeks after surgical bilateral oophorectomy or 
tubal ligation) confirmed by medical history or menopause.  Menopause is 
defined as spontaneous amenorrhea for at least 12 months not induced by a 
medical condition, or spontaneous amenorrhea of 6-12 months and a 
follicle-stimulating hormone level >40 mIU/mL.
[3]
are at least 18 years old, at the time of screening
[4]
have a body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive, at 
screening
[5]
have clinical laboratory test results within normal reference range for the 
population or investigative site, or results with acceptable deviations that are 
judged to be not clinically significant by the investigator

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Galcanezumab (LY2951742)
[6]
have venous access sufficient to allow for blood sampling as per the protocol
[7]
are reliable and willing to make themselves available for the duration of the 
study and are willing to follow study procedures
[8]
are able and willing to sign the informed consent form (ICF)
6.2.
Exclusion Criteria
Subjects will be excluded from study enrollment if they meet any of the following criteria at 
screening and/or enrollment:
[9] are investigative site personnel directly affiliated with this study and their 
immediate families.  Immediate family is defined as a spouse, biological or 
legal guardian, child, or sibling
[10] are Lilly employees or are employees of third-party organizations involved 
with the study
[11] are currently enrolled in a clinical study involving an investigational product 
or any other type of medical research judged not to be scientifically or 
medically compatible with this study  
[12] have participated, within the last 30 days, in a clinical study involving an 
investigational product.  If the previous investigational product has a long 
half-life, 5 half-lives or 30 days (whichever is longer) should have passed
[13] have previously completed or withdrawn from this study or any other study 
investigating galcanezumab, and have previously received the investigational 
product 
[14] have known allergies to galcanezumab, related compounds or any components 
of the formulation, or history of significant atopy
[15] have received treatment with any CGRP antibody (including galcanezumab), 
or antibody against CGRP receptor (including erenumab), or have received 
biologic agents (such as monoclonal antibodies) within 4 months or 
5 half-lives (whichever is longer) prior to dosing 
[16] have a history of multiple or severe allergies or has had an anaphylactic
reaction to prescription or non-prescription drugs or food
[17] have allergies to either monoclonal antibodies, diphenhydramine, epinephrine, 
or methylprednisolone
[18] have an abnormality in the 12-lead ECG that, in the opinion of the
investigator, increases the risks associated with participating in the study 
[19] have clinically significant abnormality in vital signs as determined by the 
investigator

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Galcanezumab (LY2951742)
[20] have a history or presence of significant cardiovascular, respiratory, hepatic, 
renal, gastrointestinal, endocrine, hematological, or neurological disorders 
capable of significantly altering the absorption, metabolism, or elimination of 
drugs; of constituting a risk when taking the study medication; or of 
interfering with the interpretation of data
[21] have a history of previous or presence of current neuropsychiatric disorders
[22] regularly use known drugs of abuse and/or show positive findings on drug 
screening
[23] show evidence of human immunodeficiency virus (HIV) infection and/or 
positive human HIV antibodies
[24] show evidence of hepatitis C and/or positive hepatitis C antibody
[25] show evidence of hepatitis B and/or positive hepatitis B surface antigen
[26] have a history or show evidence of active tuberculosis (TB) as documented by 
medical history and examination, chest x-rays (posterior anterior and lateral), 
and TB testing (positive [not indeterminate] T-SPOT® TB test). One repeat
of the T-SPOT® TB test is permitted following an indeterminate result.  For 
more details, see Section 9.5.7.
[27] are women who are lactating
[28] have used or intend to use over-the-counter or prescription medication within 
7 days prior to dosing and during the study without agreement by sponsor
(including traditional Chinese medicine, herbal supplements, systemic 
glucocorticoids, immunomodulatory drugs, drugs with propensity for dermal 
reactions, drugs with known liver toxicity, etc).  Stable doses of hormone 
replacement therapy (HRT; including estrogen, estrogen/progesterone 
combination, and thyroid replacement therapy) are allowed for inclusion. 
Occasional paracetamol/acetaminophen up to a 2-g dose in a 24-hour period, 
stool softener, or nasal saline preparations may be allowed for inclusion at the 
discretion of the investigator.  
[29] have donated blood of more than 400 mL or has undergone major surgery
within the 4 weeks prior to admission
[30] are unwilling to abide by caffeine restrictions as specified in Section 6.3.2
[31] have an average weekly alcohol intake that exceeds 21 units per week (males 
up to age 65) and 14 units per week (males over 65 and females), or are 
unwilling to stop alcohol consumption 48 hours prior to admission to CRU 
and during residence in the CRU (1 unit = 12 oz or 360 mL of beer; 5 oz or 
150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
[32] have had lymphoma, leukemia, or any malignancy within the past 5 years 
except for basal cell or squamous epithelial carcinomas of the skin that have 
been resected with no evidence of metastatic disease for 3 years

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Galcanezumab (LY2951742)
[33] currently smoke in excess of 5 cigarettes/day or use tobacco or nicotine
substitutes (within the last 6 months of screening), or subjects unwilling to 
refrain from smoking or are unable to abide by CRU restrictions
[34] in the opinion of the investigator or sponsor, are unsuitable for inclusion in the 
study
6.2.1. Rationale for Exclusion of Certain Study Candidates
Criteria [9] and [10] prevent conflict of interest in study participants.  Criteria [11] through [34]
exclude medical conditions, medication intolerance, and concomitant medication use that may 
confound the assessment of study endpoints or interfere with study implementation by the CRU 
(Criteria [30], [33]) or that may both constitute a risk for the subject and confound assessment of 
study endpoints: (Criteria [11]-[29], [31]-[32], [34]).
6.3.
Lifestyle and/or Dietary Requirements
Throughout the study, subjects may undergo medical assessments and review of compliance with 
requirements before continuing in the study.  
6.3.1. Meals and Dietary Restrictions
Standardized meals will be provided during each subject’s stay in the CRU. 
6.3.2. Caffeine, Alcohol, and Tobacco
Subjects should maintain to their regular habit of caffeine- or xanthine-containing food and 
drinks during the outpatient days. Two servings of xanthine-containing food and drinks per day 
will be allowed while subjects are resident at the CRU.
Alcohol will not be permitted from 48 hours prior to admission until discharge from the CRU.
While resident in the CRU, subject should abide by the CRU guidelines for smoking.  Subjects 
will be questioned about their smoking habits at screening.
6.3.3. Activity
Subjects should avoid strenuous physical activity 48 hours prior to CRU admission until at least 
30 days after dosing.
6.3.4. Contraception
Females of childbearing potential must agree to use a reliable method of birth control during the 
study and for 5 months after dosing (see Section 6.1).  Birth control is not required if the female 
is infertile due to surgical sterilization (hysterectomy, or at least 6 weeks after surgical bilateral 
oophorectomy or tubal ligation) confirmed by medical history or menopause.
6.3.5. Blood or Plasma Donations
Blood or plasma donations must not be made during the study, until 150 days after dosing.

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6.4.
Screen Failures
Individuals who do not meet the criteria for participation in this study (screen failure) may not be 
re-screened.  
Any subject with a routine screening laboratory assessment that falls outside of the specified 
parameters may undergo repeat laboratory testing 1 time, based on investigator judgment, 
without being considered a screen failure.  If the laboratory assessment again falls outside of the
specified parameters on the re-test, then the subject is to be considered a screen failure.

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7. Treatment
7.1.
Treatment Administered
Investigational product doses and formulations are summarized in Table CGAY.2.  
Table CGAY.2.
Treatments Administered
Cohort A
Cohort B
Product:
Galcanezumab
Placebo
Galcanezumab
Placebo
Total dose:
120 mg
-
240 mg
-
Concentration:
120 mg/mL
-
120 mg/mL
-
No. of injections
1 x 1 mL
1 x 1 mL
2 x 1 mL
2 x 1 mL
Route of 
administration
Subcutaneous
Subcutaneous
Subcutaneous
Subcutaneous
Formulation and 
presentation:
Solution in a prefilled 
syringe 
Placebo solution in a 
prefilled syringe
Solution in a prefilled 
syringe 
Placebo solution in a 
prefilled syringe
Injections will be administered by the clinical staff in the abdomen.  The subjects and clinical 
site staff will be blinded to the treatment; the sponsor will be unblinded.  The dose volumes and 
number of injections for subjects in each cohort are presented in Table CGAY.2.  
Galcanezumab or placebo will be administered as SC injections into the abdomen. The location 
of the injection(s) will be recorded.  Multiple injections making up a single dose (i.e. for 
Cohort B) should be apart from each other, so ISRs, if any, can be observed separately. Subjects 
may stay in the semi-recumbent position for 4 hours following study drug administration, where 
possible.
The investigator or designee is responsible for:

explaining the correct use of the investigational product(s) to the site personnel 

verifying that instructions are followed properly

maintaining accurate records of investigational product dispensing and collection

and returning all unused medication to Lilly or its designee at the end of the study
Note: In some cases, sites may destroy the material if, during the investigative site selection, the 
evaluator has verified and documented that the site has appropriate facilities and written 
procedures to dispose of clinical materials.
7.1.1. Packaging and Labeling
Galcanezumab and matching placebo (excipients only) will be supplied as an injectable solution 
in 1-mL, single-dose, prefilled, disposable manual syringes with study-specific labels.  The 
syringes (and contents) containing either galcanezumab or placebo will be visibly 
indistinguishable from each other.  Syringes will be supplied in single syringe cartons, with the 
appropriate quantity of syringes dispensed specific to the planned dispensing schedule of the
investigational product.

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Clinical study materials will be labeled according to the country’s regulatory requirements.  
7.2.
Method of Treatment Assignment
Subjects who meet the study entry criteria will be randomized to receive either galcanezumab or 
placebo in a 4:1 ratio via a computer-generated random sequence using an interactive 
web-response system (IWRS).
7.2.1. Selection and Timing of Doses
Doses will be administered according to randomization on the morning of Day 1.  The actual 
time of all dose administrations will be recorded in the subject’s electronic case report form 
(eCRF).
7.3.
Blinding
Blinding will be maintained throughout the conduct of the study as described in the separate 
Blinding Plan.
This will be a subject- and investigator-blinded study.  The subjects and clinical staff will be 
blinded to which treatment (galcanezumab or placebo) the subjects are assigned to.  The sponsor 
will be unblinded.  
Emergency unblinding for AEs may be performed through the IWRS, which may supplement or 
take the place of emergency codes generated by a computer drug-labeling system.  This option 
may be used ONLY if the subject’s well-being requires knowledge of the subject’s treatment 
assignment.  All calls resulting in an unblinding event are recorded and reported by the IWRS.
In case of an emergency, the investigator has the sole responsibility for determining if unblinding 
of a subject’s treatment assignment is warranted for medical management of the event.  The 
subject’s safety must always be the first consideration in making such a determination.  If the 
investigator decides that unblinding is warranted, it is the responsibility of the investigator to 
promptly document the decision and rationale and notify Lilly as soon as possible.
7.4.
Dose Modification
Dose adjustments are not permitted in this study.
7.5.
Preparation/Handling/Storage/Accountability
The investigator or designee must confirm appropriate temperature conditions have been 
maintained, as communicated by the sponsor, during transit for all investigational product
received and any discrepancies are reported and resolved before use of the study treatment.
Only participants enrolled in the study may receive investigational product or study materials, 
and only authorized site staff may supply or administer investigational product. All 
investigational product should be stored in an environmentally controlled and monitored (manual 
or automated) area in accordance with the labeled storage conditions with access limited to the 
investigator and authorized site staff.

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The packaged investigational product must be stored according to the storage requirements 
printed onto the packaging label.  
To administer the galcanezumab injections, the investigational sites are to refer to the pharmacy 
binder for the preparation and handling instructions of the packaged investigational product.
The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study treatment accountability, reconciliation, and record maintenance (such as
receipt, reconciliation and final disposition records).
7.6.
Treatment Compliance
The investigational product will be administered at the clinical site, and documentation of 
treatment administration will occur at the site.
7.7.
Concomitant Therapy
Stable doses of HRT, including estrogen, estrogen/progesterone combination, and thyroid 
replacement therapy, will be allowed during the study.  Unless agreed by the sponsor, 
over-the-counter medications or other prescription medications are to be avoided within 7 days 
prior to dosing and during the study (especially traditional Chinese medicine, herbal 
supplements, systemic glucocorticoids, immunomodulatory drugs, drugs with propensity for 
dermal reactions, drugs with known liver toxicity, etc).  
If the need for concomitant medication arises, inclusion or continuation of the subject may be at 
the discretion of the investigator after consultation with a Lilly Clinical Pharmacologist (CP) or 
Clinical Research Physician (CRP).  Occasional paracetamol/acetaminophen, up to a 2-g dose in 
a 24-hour period, stool softener, or nasal saline preparations may be used at the discretion of the 
investigator.  Any additional medication used during the course of the study must be 
documented.
7.8.
Treatment after the End of the Study
This section is not applicable for this study.

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8. Discontinuation Criteria
Subjects discontinuing from the study prematurely for any reason must complete AE and 
follow-up procedures per Section 2 of this protocol.
8.1.
Discontinuation from Study Treatment
Not applicable for this single-dose study.
8.1.1. Discontinuation of Inadvertently Enrolled Subjects
If the sponsor or investigator identifies a patient who did not meet enrollment criteria and was 
inadvertently enrolled, a discussion must occur between the Lilly CP/CRP and the investigator to 
determine if the patient may continue in the study.  If both agree it is medically appropriate to 
continue, the investigator must obtain documented approval from the Lilly CP/CRP to allow the 
inadvertently enrolled patient to continue in the study.  
8.2.
Discontinuation from the Study
Subjects will be discontinued in the following circumstances:

Enrollment in any other clinical study involving an investigational product or enrollment 
in any other type of medical research judged not to be scientifically or medically 
compatible with this study

Participation in the study needs to be stopped for medical, safety, regulatory, or other 
reasons consistent with applicable laws, regulations, and good clinical practice (GCP)

Investigator Decision
o
the investigator decides that the subject should be discontinued from the study

Subject Decision
o
the subject, or legal representative, requests to be withdrawn from the study.
8.3.
Subjects Lost to Follow-up
A subject will be considered lost to follow-up if he or she repeatedly fails to return for scheduled 
visits and is unable to be contacted by the study site.  Site personnel are expected to make 
diligent attempts to contact subjects who fail to return for a scheduled visit or were otherwise 
unable to be followed up by the site.

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9. Study Assessments and Procedures
Section 2 lists the Schedule of Activities, detailing the study procedures and their timing 
(including tolerance limits for timing).
Appendix 2 lists the clinical laboratory tests that will be performed for this study.
Appendix 4 provides a summary of the maximum number and volume of invasive samples, for
all sampling, during the study.
Unless otherwise stated in subsections below, all samples collected for specified laboratory tests 
will be destroyed within 60 days of receipt of confirmed test results.  Certain samples may be 
retained for a longer period, if necessary, to comply with applicable laws, regulations, or 
laboratory certification standards.
9.1.
Efficacy Assessments
This section is not applicable for this study.
9.2.
Adverse Events
Investigators are responsible for monitoring the safety of subjects who have entered this study 
and for alerting Lilly or its designee to any event that seems unusual, even if this event may be 
considered an unanticipated benefit to the subject.
The investigator is responsible for the appropriate medical care of subjects during the study.
Investigators must document their review of each laboratory safety report.
The investigator remains responsible for following, through an appropriate health care option, 
AEs that are serious or otherwise medically important, considered related to the investigational 
product or the study, or that caused the subject to discontinue the investigational product before 
completing the study.  The subject should be followed until the event resolves, stabilizes with 
appropriate diagnostic evaluation, or is reasonably explained.  The frequency of follow-up 
evaluations of the AE is left to the discretion of the investigator.
After the ICF is signed, study site personnel will record, via eCRF, the occurrence and nature of 
each subject’s preexisting conditions.  Additionally, site personnel will record any change in the 
condition(s) and the occurrence and nature of any AEs.  
The investigator will interpret and document whether or not an AE has a reasonable possibility 
of being related to study treatment, study device, or a study procedure, taking into account 
concomitant treatment or pathologies.  
A “reasonable possibility” means that there is a potential cause and effect relationship between 
the investigational product, study device and/or study procedure and the AE.
Planned surgeries should not be reported as AEs unless the underlying medical condition has 
worsened during the course of the study.

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9.2.1. Serious Adverse Events
An SAE is any AE from this study that results in one of the following:

death

initial or prolonged inpatient hospitalization

a life-threatening experience (that is, immediate risk of dying)

persistent or significant disability/incapacity

congenital anomaly/birth defect

important medical events that may not be immediately life-threatening or result in death 
or hospitalization but may jeopardize the patient or may require intervention to prevent 
one of the other outcomes listed in the definition above

when a condition related to the PFS necessitates medical or surgical intervention to 
preclude either permanent impairment of a body function or permanent damage to a body 
structure, the serious outcome of “required intervention” will be assigned.
Study site personnel must alert the Lilly CRP/CP, or its designee, of any SAE as soon as 
practically possible.
Additionally, study site personnel must alert Lilly Global Patient Safety, or its designee, of any 
SAE within 24 hours of investigator awareness of the event via a sponsor-approved method.  If 
alerts are issued via telephone, they are to be immediately followed with official notification on 
study-specific SAE forms.  This 24-hour notification requirement refers to the initial SAE 
information and all follow-up SAE information.
Although all AEs are recorded in the eCRF after signing informed consent, SAE reporting to the
sponsor begins after the subject has signed informed consent and has received investigational 
product.  However, if an SAE occurs after signing informed consent, but prior to receiving 
investigational product, AND is considered reasonably possibly related to a study procedure then 
it MUST be reported.
Investigators are not obligated to actively seek AEs or SAEs in subjects once they have 
discontinued from and/or completed the study (the subject summary eCRF has been completed).  
However, if the investigator learns of any SAE, including a death, at any time after a subject has 
been discharged from the study, and he/she considers the event reasonably possibly related to the 
study treatment or study participation, the investigator must promptly notify Lilly. 
Pregnancy (maternal or paternal exposure to investigational product) does not meet the definition 
of an AE.  However, to fulfill regulatory requirements any pregnancy should be reported 
following the SAE process to collect data on the outcome for both mother and fetus.
9.2.1.1.
Suspected Unexpected Serious Adverse Reactions 
Suspected unexpected serious adverse reactions (SUSARs) are serious events that are not listed 
in the IB and that the investigator reports as related to investigational product or procedure.  Lilly 

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Galcanezumab (LY2951742)
has procedures that will be followed for the recording and expedited reporting of SUSARs that 
are consistent with global regulations and the associated detailed guidances.
9.2.2. Complaint Handling
Lilly collects product complaints on investigational products and drug delivery systems used in 
clinical trials in order to ensure the safety of study participants, monitor quality, and to facilitate 
process and product improvements.
Subjects should be instructed to contact the investigator as soon as possible if he or she has a 
complaint or problem with the investigational product so that the situation can be assessed.
9.3.
Treatment of Overdose
For the purposes of this study, an overdose of galcanezumab is considered any dose higher than 
the dose assigned through randomization.  There is no specific antidote for galcanezumab.  In 
case of known or suspected overdose, it is recommended that the subject be monitored for 
any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted 
immediately.
9.4.
Pharmacokinetics
At the visits and times specified in the Schedule of Activities, venous blood samples of 
approximately 2 mL (maximum 2.5 mL) each will be collected to determine the serum 
concentrations of galcanezumab.  A maximum of 3 samples may be collected at additional time 
points during the study if warranted and agreed upon between both the investigator and sponsor.  
Instructions for the collection and handling of blood samples will be provided by the sponsor.  
The actual date and time (24-hour clock time) of each sampling will be recorded.
Drug concentration information that may unblind the study will not be reported to investigative 
sites or blinded personnel until the study has been unblinded.
9.4.1. Bioanalysis
Samples will be analyzed at a laboratory approved by the sponsor and stored at a facility 
designated by the sponsor.
Concentrations of galcanezumab will be assayed using a validated method.  Analyses of samples 
collected from placebo-treated subjects are not planned.
Bioanalytical samples collected to measure investigational product concentrations will be 
retained for a maximum of 1 year following last subject visit for the study.  
9.5.
Safety
9.5.1. Laboratory Tests
For each subject, laboratory tests detailed in Appendix 2 should be conducted according to the 
Schedule of Activities (Section 2).

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All safety laboratory tests will be conducted at a local laboratory.
9.5.2. Vital Signs
For each subject, vital signs measurements should be conducted according to the Schedule of 
Activities (Section 2) and as clinically indicated.  
Blood pressure and pulse rate should be measured after at least 5 minutes in the sitting position.
Unscheduled orthostatic vital signs should be assessed, if possible, during any AE of dizziness or 
posture-induced symptoms.  If orthostatic measurements are required, subjects should be supine 
for at least 5 minutes and stand for at least 2 minutes.
9.5.3. Electrocardiograms
For each subject, a single 12-lead digital ECG will be collected according to the Schedule of 
Activities (Section 2).  Any clinically significant findings from ECGs that result in a diagnosis 
and that occur after the subject receives the first dose of the investigational product, should be 
reported to Lilly, or its designee, as an AE via eCRF. 
Electrocardiograms must be recorded before collecting any blood for safety or PK tests.
Subjects must be supine for at least 5 minutes before ECG collection and remain supine but 
awake during ECG collection.  Electrocardiograms may be obtained at additional times, when 
deemed clinically necessary.  All ECGs recorded should be stored at the investigational site.
Electrocardiograms will be interpreted by a qualified physician (the investigator or qualified 
designee) at the site as soon after the time of ECG collection as possible, and ideally while the 
subject is still present, to determine whether the subject meets entry criteria at the relevant 
visit(s) and for immediate subject management, should any clinically relevant findings be 
identified.  
If a clinically significant finding is identified after enrollment, the investigator will determine if 
the subject can continue in the study.  The investigator, or qualified designee, is responsible for 
determining if any change in subject management is needed, and must document his/her review 
of the ECG printed at the time of collection.  Any new clinically relevant finding should be 
reported as an AE.
9.5.4. Injection Site Assessments
The investigator will record additional details regarding AEs related to injection sites and 
hypersensitivity events. If an ISR occurs, it will be closely monitored until resolution.  
Investigational site staff will be provided with separate instructions/training in how to 
consistently evaluate ISRs and their severity.  
9.5.5. Physical Examination
Physical examinations and routine medical assessments will be conducted as specified in the 
Schedule of Activities (Section 2) and as clinically indicated.

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9.5.6. Body Weight
Body weight will be recorded as specified in the Schedule of Activities (Section 2) and as 
clinically indicated.
9.5.7. Tuberculosis Testing
Subjects will be tested as indicated in the Schedule of Activities (Section 2) for evidence of
active TB, which includes a T-SPOT® TB test. If the first test result is indeterminate, 1 repeat is 
allowed. If the repeat result is indeterminate, the subject will be excluded from the study.
Subjects who have had household contact with a person with active TB must be excluded unless
appropriate and documented prophylaxis treatment for TB has been completed. Subjects with 
any history of active TB are excluded from the study, regardless of previous or current TB 
treatments.
9.5.8. Safety Monitoring
The Lilly CP or CRP/scientist will monitor safety data throughout the course of the study.
Lilly will review SAEs within time frames mandated by company procedures.  The Lilly CP or 
CRP will review the following data:

trends in safety data

laboratory analytes

AEs including monitoring of ISRs and allergic reactions.
When appropriate, the Lilly CP or CRP will consult with the functionally independent Global 
Patient Safety therapeutic area physician or clinical research scientist.
In the event that safety monitoring uncovers an issue that needs to be addressed by unblinding at 
the group level, additional analyses of the safety data will be conducted by the personnel 
included in the Blinding Plan.
9.6.
Pharmacodynamics
9.6.1. Immunogenicity Assessments 
At the visits and times specified in the Schedule of Activities (Section 2), venous blood samples 
of approximately 10 mL each will be collected to determine antibody production against 
galcanezumab.  Treatment-emergent antidrug antibodies (TE-ADAs) are defined in Section 
10.3.3.  In the event of drug hypersensitivity reactions (immediate or non-immediate), additional 
samples will be collected as close to the onset of the event as possible, at the resolution of the 
event, and 30 days following the event.  If additional immunogenicity testing samples are taken
at an unscheduled visit due to a hypersensitivity reaction then a corresponding PK sample will 
also be taken at that time.  Instructions for the collection and handling of blood samples will be 

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Galcanezumab (LY2951742)
provided by the sponsor.  The actual date and time (24-hour clock time) of each sampling will be 
recorded.  
Immunogenicity will be assessed by a validated assay designed to detect ADAs in the presence 
of galcanezumab at a laboratory approved by the sponsor.  Antibodies may be further 
characterized and/or evaluated for their ability to neutralize the activity of galcanezumab using a 
validated assay.  
Samples will be retained for a maximum of 15 years after the last subject visit, or for a shorter 
period if local regulations and Ethical Review Boards (ERBs) allow, at a facility selected by the 
sponsor.  The duration allows the sponsor to respond to future regulatory requests related to the 
investigational product.  Any samples remaining after 15 years will be destroyed.
9.7.
Genetics
A blood sample will be collected for pharmacogenetic analysis as specified in the Schedule of 
Activities, where local regulations allow.  
Samples will not be used to conduct unspecified disease or population genetic research either 
now or in the future.  Samples will be used to investigate variable exposure or response to 
galcanezumab and to investigate genetic variants thought to play a role in migraine and/or 
cluster headache.  Assessment of variable response may include evaluation of AEs or differences 
in efficacy.  
All samples will be coded with the subject number.  These samples and any data generated can 
be linked back to the subject only by the investigative site personnel.  
Samples will be retained for a maximum of 15 years after the last subject visit, or for a shorter 
period if local regulations and/or ERBs impose shorter time limits, for the study at a facility 
selected by Lilly or its designee.  This retention period enables use of new technologies, response 
to regulatory questions, and investigation of variable response that may not be observed until 
later in the development of galcanezumab or after galcanezumab is commercially available.  
Molecular technologies are expected to improve during the 15 year storage period and therefore 
cannot be specifically named.  However, existing approaches include whole genome or exome 
sequencing, genome wide association studies, multiplex assays, and candidate gene studies.  
Regardless of technology utilized, data generated will be used only for the specific research 
scope described in this section. 
9.8.
Biomarkers
This section is not applicable for this study.
9.9.
Health Economics
This section is not applicable for this study.

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10.
Statistical Considerations and Data Analysis
10.1. Sample Size Determination
Approximately 30 subjects may be enrolled in this study to adjust for any discontinuations and 
try to ensure that approximately 20 subjects complete the study (10 per cohort; 8 galcanezumab 
and 2 placebo).  The sample size is customary for Phase 1 studies evaluating safety and PK, and 
is not powered on the basis of statistical hypothesis testing.
Subjects who receive treatment may not be replaced.
10.2. Populations for Analyses
10.2.1. Study Participant Disposition
A detailed description of subject disposition will be provided at the end of the study. 
10.2.2. Study Participant Characteristics
The subject’s age, sex, weight, height, BMI, race/sub-race, tobacco/nicotine habits, or other 
demographic characteristics will be recorded and may be used in the PK, safety, and 
immunogenicity analyses as quantitative or classification variables
10.3. Statistical Analyses
Statistical analysis of this study will be the responsibility of Eli Lilly and Company or its 
designee.
Pharmacokinetic and immunogenicity analyses will be conducted on the full analysis set.  This 
set includes all data from all randomized subjects receiving at least 1 dose of the investigational 
product according to the treatment the subjects actually received.  
Safety analyses will be conducted for all enrolled subjects, whether or not they completed all 
protocol requirements.
Additional exploratory analyses of the data will be conducted as deemed appropriate.  Study 
results may be pooled with the results of other studies for population PK analysis purposes.  
10.3.1. Pharmacokinetic Analyses
10.3.1.1. Pharmacokinetic Parameter Estimation
Pharmacokinetic parameters for galcanezumab will be calculated by standard noncompartmental 
methods of analysis.
The primary parameters for analysis will be Cmax and AUC(0-∞) of galcanezumab.  Other 
noncompartmental parameters, such as area under the concentration versus time curve from time 
zero to time t, where t is the last time point with a measurable concentration (AUC[0-tlast]), time 
of maximum observed drug concentration (tmax), t1/2, apparent clearance, and apparent volume 
of distribution may be reported.

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Galcanezumab (LY2951742)
10.3.1.2. Pharmacokinetic Statistical Inference
The PK parameter estimates for galcanezumab will be summarized using appropriate descriptive 
statistics.  
10.3.2. Safety Analyses
10.3.2.1. Clinical Evaluation of Safety
All investigational product and protocol procedure AEs will be listed, and if the frequency of 
events allows, safety data will be summarized using descriptive methodology.
The incidence of symptoms for each treatment will be presented by severity and by association 
with investigational product as perceived by the investigator.  Symptoms reported to occur prior 
to enrollment will be distinguished from those reported as new or increased in severity during the 
study.  Each symptom will be classified by the most suitable term from the medical regulatory 
dictionary.
The number of investigational product-related SAEs will be reported.
10.3.2.2. Statistical Evaluation of Safety
Safety parameters that will be assessed include safety lab parameters and vital signs.  The 
parameters will be listed, and summarized using standard descriptive statistics.  Additional 
analysis will be performed if warranted upon review of the data.
10.3.3. Evaluation of Immunogenicity 
The frequency and percentage of subjects with preexisting ADA and with TE-ADA+ to 
galcanezumab will be tabulated. Treatment-emergent ADAs are defined as those with a titer 
2-fold (1 dilution) greater than the minimum required dilution if no ADAs were detected at 
baseline (treatment-induced ADA) or those with a 4-fold (2 dilutions) increase in titer compared 
to baseline if ADAs were detected at baseline (treatment-boosted ADA). For the TE-ADA+ 
subjects the distribution of maximum titers will be described.  The frequency of neutralizing 
antibodies will also be tabulated in TE-ADA+ subjects.
The relationship of ADA to PK parameters and safety endpoints may be assessed.
10.3.4. Interim Analyses
No interim analyses are planned for this study.  If an unplanned interim analysis is deemed 
necessary, the Lilly CP, CRP/investigator, or designee will consult with the appropriate medical 
director or designee to determine if it is necessary to amend the protocol.

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Galcanezumab (LY2951742)
11.
References
None cited.

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Appendix 1. Abbreviations and Definitions 
 

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Term 
Definition 
TE-ADA 
Treatment-emergent antidrug antibody 
AE 
adverse event:  Any untoward medical occurrence in a patient or clinical investigation 
subject administered a pharmaceutical product that does not necessarily have a causal 
relationship with this treatment.  An AE can therefore be any unfavorable and unintended 
sign (including an abnormal laboratory finding), symptom, or disease temporally associated 
with the use of a medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product. 
AUC 
area under the concentration versus time curve 
AUC(0-∞) 
area under the concentration versus time curve from time zero to infinity 
AUC(0-tlast) 
area under the concentration versus time curve from time zero to time t, where t is the last 
time point with a measurable concentration 
blinding 
A procedure in which one or more parties to the study are kept unaware of the treatment 
assignment(s).  Unless otherwise specified, blinding will remain in effect until final 
database lock. 
A single-blind study is one in which the investigator and/or his staff are aware of the 
treatment but the subject is not, or vice versa, or when the sponsor is aware of the treatment 
but the investigator and/his staff and the subject are not.  A double-blind study is one in 
which neither the subject nor any of the investigator or sponsor staff who are involved in 
the treatment or clinical evaluation of the subjects are aware of the treatment received. 
BMI 
body mass index 
CGRP 
calcitonin gene-related peptide 
CIOMS 
Council for International Organizations of Medical Sciences 
Cmax 
maximum observed drug concentration 
complaint 
A complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, purity, durability, reliability, safety or effectiveness, or 
performance of a drug or drug delivery system. 
compliance 
Adherence to all the study-related requirements, good clinical practice (GCP) requirements, 
and the applicable regulatory requirements. 
confirmation 
A process used to confirm that laboratory test results meet the quality requirements defined 
by the laboratory generating the data and that Lilly is confident that results are accurate.  
Confirmation will either occur immediately after initial testing or will require that samples 
be held to be retested at some defined time point, depending on the steps required to obtain 
confirmed results. 
CP 
clinical pharmacologist 
CRP 
clinical research physician:  Individual responsible for the medical conduct of the study.  
Responsibilities of the CRP may be performed by a physician, clinical research scientist, 
global safety physician or other medical officer. 

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CRU 
clinical research unit 
ECG 
electrocardiogram(s) 
eCRF 
electronic case report form 
ED 
early discontinuation 
enroll 
The act of assigning a subject to a treatment.  Subjects who are enrolled in the study are 
those who have been assigned to a treatment. 
enter 
Subjects entered into a study are those who sign the informed consent form directly or 
through their legally acceptable representatives. 
ERB 
Ethical Review Board 
FSH 
follicle-stimulating hormone 
GCP 
good clinical practice 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HRT 
hormone replacement therapy 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
ICH 
International Council for Harmonization 
informed consent 
A process by which a subject voluntarily confirms his or her willingness to participate in a 
particular study, after having been informed of all aspects of the study that are relevant to 
the subject’s decision to participate.  Informed consent is documented by means of a 
written, signed and dated informed consent form.   
interim analysis 
An interim analysis is an analysis of clinical study data, separated into treatment groups, 
that is conducted before the final reporting database is created/locked. 
Investigational 
product (IP) 
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference 
in a clinical study, including products already on the market when used or assembled 
(formulated or packaged) in a way different from the authorized form, or marketed products 
used for an unauthorized indication, or marketed products used to gain further information 
about the authorized form. 
investigator 
A person responsible for the conduct of the clinical study at a study site.  If a study is 
conducted by a team of individuals at a study site, the investigator is the responsible leader 
of the team and may be called the principal investigator. 
ISR 
injection site reaction 

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Galcanezumab (LY2951742) 
IWRS 
interactive web-response system 
Legal 
Representative 
An individual or judicial or other body authorized under applicable law to consent, on 
behalf of a prospective subject, to the subject’s participation in the clinical study. 
Non-
investigational 
product (non-IP) 
A product that is not being tested or used as a reference in the clinical study, but is provided 
to subjects and used in accordance with the protocol, such as:  concomitant or rescue/escape 
medication for preventative, diagnostic, or therapeutic reasons, medication to ensure 
adequate medical care, and/or products used to induce a physiological response. 
PD 
pharmacodynamic(s) 
PFS 
pre-filled syringe 
PGx 
pharmacogenetics 
PK 
pharmacokinetic(s) 
randomize 
the process of assigning subjects to an experimental group on a random basis 
RBC 
red blood cells 
SAE 
serious adverse event 
SC 
subcutaneous 
SCR/screen 
The act of determining if an individual meets minimum requirements to become part of a 
pool of potential candidates for participation in a clinical study.   
SUSARs 
suspected unexpected serious adverse reactions  
t1/2 
half-life associated with the terminal elimination phase 
TB 
tuberculosis 
TE-ADA 
Treatment-emergent antidrug antibody 
TEAE 
treatment-emergent adverse event:  Any untoward medical occurrence that emerges during 
a defined treatment period, having been absent pretreatment, or worsens relative to the 
pretreatment state, and does not necessarily have to have a causal relationship with this 
treatment  
tmax 
time of maximum observed drug concentration 
WBC 
white blood cells 

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Appendix 2. Clinical Laboratory Tests 
Safety Laboratory Tests 
Hematologya 
Clinical Chemistrya 
Hematocrit 
Sodium 
Hemoglobin 
Potassium 
Erythrocyte count (RBC) 
Glucose, random 
Mean cell volume  
Blood urea nitrogen (BUN) 
Mean cell hemoglobin  
Total protein 
Mean cell hemoglobin concentration  
Albumin 
Leukocytes (WBC)  
Total bilirubin 
Platelets 
Alkaline phosphatase (ALP) 
Absolute counts of: 
Aspartate aminotransferase (AST) 
Neutrophils 
Alanine aminotransferase (ALT) 
Lymphocytes 
Creatinine 
Monocytes 
 
Eosinophils 
Serologyc 
Basophils 
Hepatitis B surface antigen 
Cell morphology 
Hepatitis C antibody 
 
HIV 
Urinalysisa 
 
Specific gravity 
Ethanol testingd 
pH 
Urine drug screend 
Protein 
Pregnancy teste 
Glucose 
FSH (females only; to confirm postmenopausal status)c  
Ketones 
T-SPOT® TB testc 
Bilirubin 
 
Urobilinogen 
 
Blood 
 
Nitrite 
 
Microscopic examination of sedimentb 
 
 
 
 
 
Abbreviations:  FSH = follicle-stimulating hormone; HIV = human immunodeficiency virus; RBC = red blood cells; 
TB = tuberculosis; WBC = white blood cells. 
a All safety laboratory tests will be conducted by the local laboratory.  
b Test only if dipstick result is abnormal. 
c Performed at screening only. 
d Urine drug screen and ethanol breath testing may be repeated prior to admission to the clinical research unit and 
as indicated. 
e Females only.  Blood pregnancy test will be done on screening, and may be repeated using urine test prior to 
admission to the clinical research unit and as indicated.  
 
 
 

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Appendix 3. Study Governance, Regulatory and Ethical 
Considerations 
Informed Consent 
The investigator is responsible for: 
 ensuring that the subject understands the nature of the study, the potential risks and 
benefits of participating in the study, and that their participation is voluntary. 
 ensuring that informed consent is given by each subject or legal representative.  This 
includes obtaining the appropriate signatures and dates on the informed consent form 
(ICF) prior to the performance of any protocol procedures and prior to the administration 
of investigational product. 
 answering any questions the subject may have throughout the study and sharing in a 
timely manner any new information that may be relevant to the subject’s willingness to 
continue his or her participation in the study. 
 providing a copy of the ICF to the participant or the participant’s legal representative and 
retaining a copy on file. 
Recruitment 
Lilly or its designee is responsible for the central recruitment strategy for patients.  Individual 
investigators may have additional local requirements or processes.  Study-specific recruitment 
material should be approved by Lilly. 
Ethical Review 
The investigator must give assurance that the ethical review board (ERB) was properly 
constituted and convened as required by International Council for Harmonization (ICH) 
guidelines and other applicable laws and regulations. 
Documentation of ERB approval of the protocol and the ICF must be provided to Lilly before the 
study may begin at the investigative site(s).  Lilly or its representatives must approve the ICF 
before it is used at the investigative site(s).  All ICFs must be compliant with the ICH guideline 
on GCP. 
The study site’s ERB(s) should be provided with the following: 
 the current IB and updates during the course of the study 
 ICF 
 relevant curricula vitae 
Regulatory Considerations 
This study will be conducted in accordance with the protocol and with: 

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Galcanezumab (LY2951742)
1) consensus ethics principles derived from international ethics guidelines, 
including the Declaration of Helsinki and Council for International 
Organizations of Medical Sciences (CIOMS) International Ethical Guidelines 
2) applicable ICH GCP Guidelines 
3) applicable laws and regulations
Some of the obligations of the sponsor will be assigned to a third-party organization.
Protocol Signatures
The sponsor’s responsible medical officer will approve the protocol, confirming that, to the best 
of his or her knowledge, the protocol accurately describes the planned design and conduct of the 
study.  
After reading the protocol, each principal investigator will sign the protocol signature page and 
send a copy of the signed page to a Lilly representative.
Final Report Signature
The investigator or designee will sign the clinical study report for this study, indicating 
agreement with the analyses, results, and conclusions of the report.
The sponsor’s responsible medical officer and statistician will sign/approve the final clinical 
study report for this study, confirming that, to the best of his or her knowledge, the report 
accurately describes the conduct and results of the study.
Data Quality Assurance
To ensure accurate, complete, and reliable data, Lilly or its representatives will do the following:

provide instructional material to the study sites, as appropriate.

provide training to instruct the investigators and study coordinators.  This training will 
give instruction on the protocol, the completion of the electronic case report form 
(eCRF), and study procedures.

make periodic visits to the study site.

be available for consultation and stay in contact with the study site personnel by mail, 
telephone, and/or fax.

review and evaluate eCRF data and/or use standard computer edits to detect errors in data 
collection.

conduct a quality review of the database.
In addition, Lilly or its representatives will periodically check a sample of the subject data 
recorded against source documents at the study site.  The study may be audited by Lilly and/or 
regulatory agencies at any time.  Investigators will be given notice before an audit occurs.

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Galcanezumab (LY2951742)
The investigator will keep records of all original source data.  This might include laboratory 
tests, medical records, and clinical notes.  If requested, the investigator will provide the sponsor, 
applicable regulatory agencies, and applicable ERBs with direct access to the original source 
documents.
Data Collection Tools/Source Data
An electronic data capture system will be used in this study.  The site must define and retain all 
source records and must maintain a record of any data where source data are directly entered into 
the data capture system.
Data Protection
Data systems used for the study will have controls and requirements in accordance with local 
data protection law.  
The purpose and use of subject personal information collected will be provided in a written 
document to the subject by the sponsor.
Study and Site Closure
Discontinuation of Study Sites
Study site participation may be discontinued if Lilly or its designee, the investigator, or the ERB 
of the study site judges it necessary for medical, safety, regulatory, or other reasons consistent 
with applicable laws, regulations, and GCP.
Discontinuation of the Study
The study will be discontinued if Lilly or its designee judges it necessary for medical, safety, 
regulatory, or other reasons consistent with applicable laws, regulations, and GCP.

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Appendix 4. Blood Sampling Summary
This table summarizes the approximate number of venipunctures and blood volumes for all 
blood sampling (screening, safety laboratories, and bioanalytical assays) during the study.  Fewer 
venipunctures and blood draws may actually occur, but this will not require a protocol 
amendment.
Protocol I5Q-MC-CGAY Sampling Summary
Purpose
Maximum Blood Volume 
per Sample (mL)
Maximum Number 
of Blood Samples
Maximum Total 
Volume (mL)
Screening testsa
28
1
28
Clinical laboratory testsa
8
6
48
Galcanezumab Pharmacokineticsb
2.5
17
42.5
Immunogenicityb
10
6
60
Pharmacogenetics
10
1
10
Total
188.5
Total for clinical purposes [rounded up to nearest 10 mL]
190
a
Additional samples may be drawn if needed for safety purposes.
b
Additional samples may be drawn in the event of hypersensitivity reactions.

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Galcanezumab (LY2951742)
Appendix 5.
Protocol Amendment I5Q-MC-CGAY(a) 
Summary A Randomized, Placebo-Controlled, Single-Dose 
Study to Assess the Pharmacokinetics, Safety, and 
Tolerability of Galcanezumab in Healthy Chinese Subjects
Overview
Protocol I5Q-MC-CGAY [A Randomized, Placebo-Controlled, Single-Dose Study to Assess the 
Pharmacokinetics, Safety, and Tolerability of Galcanezumab in Healthy Chinese Subjects] has 
been amended.  The new protocol is indicated by Amendment (a) and will be used to conduct the 
study in place of any preceding version of the protocol.
The overall changes and rationale for the changes made to this protocol are described in the 
following table:
Table CGAY.3.
Amendment Summary for Protocol I5Q-MC-CGAY Amendment(a)
Section # and Name
Description of Change
Brief Rationale
3.2.1.  Clinical Experience with 
Galcanezumab
The dose ranges of Phase 2 and 
3 studies have been added to the 
clinical background. Information 
about galcanezumab marketed 
approval also added. 
The additional background has 
been added to provide a summary 
of all galcanezumab dose ranges 
used to date in clinical studies as 
well as detailing the approved 
dose. 
2.  Schedule of Activities 
5.1 Overall Design
Wording has been added to allow 
visits within Day -1 to Day 15 to be 
inpatient if necessary.
Inpatient visits aim to improve 
subject visit compliance  for those 
subjects who reside far from the 
clinical site.
2.  Schedule of Activities 
6.2.  Exclusion Criteria
9.5.7.  Tuberculosis Testing
Appendix 2.  Clinical Laboratory Tests
Exclusion criterion 26 has been 
expanded to exclude subjects with a 
history of tuberculosis (TB) and 
outline a mandatory T-SPOT® TB 
test and chest x-ray examination.
Section 9.5.7 created to supplement 
exclusion criterion 26 and provide 
more detail regarding exclusion of 
subjects with exposure to TB.  
TB test and chest x-ray have been 
added to the Schedule of Activities
at screening and the TB test has 
been added to the Clinical 
Laboratory Tests table.  
To provide solid evidence 
supporting an absence of active
tuberculosis in subjects.

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Section # and Name
Description of Change
Brief Rationale
7.1.  Treatment Administered 
Reference to the clinical pharmacist 
being unblinded has been removed.
Requirement to dose in a sitting 
position during dosing has been 
removed and flexibility has been 
added for subject positioning 
postdose.
Detail regarding preparation and 
storage of investigational product 
removed.
To clarify that only the sponsor 
will be unblinded.
Positioning during and after 
galcanezumab dosing updated to 
reflect protocols in the same 
program.
Investigational product detail 
moved to a more relevant section 
of the protocol (Section 7.5).
7.2.  Method of Treatment Assignment
Clarification added regarding 
subject randomization via a 
computer-generated random 
sequence using an interactive 
web-response system (IWRS).
Change reflects randomization 
method used by the study site.
7.3  Blinding
Reference to the clinical pharmacist
being unblinded has been removed.
The method of unblinding has been 
changed from emergency codes to 
being performed through the IWRS.
To clarify that only the sponsor 
will be unblinded.
Change reflects the unblinding 
procedure when using an IWRS.
7.5.  Preparation/Handling/Storage/
Accountability
Detail regarding investigational 
product storage and preparation 
instructions has been added.
To ensure investigational product 
details are in the relevant section 
of the protocol. 
9.5.1.  Laboratory Tests 
Appendix 2.  Clinical Laboratory Tests
The location of safety test analysis 
has been updated to the local 
laboratory at all time points rather 
than a central vendor. 
Change allows subject safety data 
to be reviewed within a timely 
manner at the clinical site. 
10.3.2.2.  Statistical Evaluation of 
Safety
Removed ECG parameters from list 
of safety parameters that will be 
assessed. 
ECGs will not be databased 
therefore do not require statistical 
evaluation. 
Appendix 4.  Blood Sampling 
Summary
Maximum blood volumes per 
sample for screening tests and 
clinical laboratory tests have been 
updated. 
Change reflects blood volume 
requirements for safety testing at 
the local laboratory. 
The synopsis and abbreviations list have been updated accordingly with the outlined changes 
above and are not detailed on the following pages.

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Revised Protocol Sections
Note:
All deletions have been identified by strikethroughs.
All additions have been identified by the use of underscore.
2.  Schedule of Activities

A row was added to the schedule for ‘Chest x-ray and T-SPOT test’ to be performed at 
screening only. 

The abbreviation ‘T-SPOT = T-SPOT® tuberculosis test’ was added to the abbreviation 
footnote.

Footnote ‘d’ was updated as follows: 
d Subjects will be admitted to the CRU on Day -1, and will may be discharged on Day 3 after the
procedures scheduled at 48 hours after dosing have been completed.  Subjects may remain inpatient up to 
Day 15 to improve visit compliance, at the discretion of the investigator.  Unless specified, safety 
monitoring procedures should be done close to the dosing time on Day 1, except for screening and the day 
before dosing.
3.2.1.  Clinical Experience with Galcanezumab
Four clinical pharmacology studies with galcanezumab have been completed to date in healthy 
subjects.  The subject population included 446 healthy subjects of whom 419 subjects received at 
least 1 dose of galcanezumab (dose range 1 to 600 mg).  Two Phase 2 studies and the 
double-blinded phase of three Phase 3 studies in migraine patients have completed, and 
demonstrated consistent efficacy in migraine prevention.  The treatment phase of a further 
Phase 3 open-label study in migraine patients has also completed.  Additional Phase 3 studies in 
migraine patients are ongoing, including 2 studies conducted in Japanese patients. In the 
completed Phase 2 studies, a total of 380 migraine patients received repeated doses of 
galcanezumab; 150 mg every 2 weeks in 1 study, or 5 to 300 mg every 4 weeks in the other.  In
the completed Phase 3 studies, safety and efficacy of galcanezumab were tested in migraine 
patients who received either placebo or galcanezumab at doses of 120 mg monthly, after a 
240 mg loading dose, or 240 mg monthly.  Safety and efficacy profiles of both doses were 
comparable.
In September 2018, galcanezumab (Emgality™) was approved in the US for the prevention of 
migraine in adults.  Additionally, galcanezumab was approved in the EU in November 2018, for 
the prophylaxis of migraine in adults who have at least 4 migraine days per month.  The 
approved dose of galcanezumab is a loading dose of 240 mg followed by monthly doses of 
120 mg.
In addition to migraine prevention, safety and efficacy of galcanezumab were also tested in 
2 completed Phase 3 studies in patients with episodic and chronic cluster headache at 300 mg 
monthly dose.

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5.  Study Design 
Subjects will be admitted to the clinical research unit (CRU) on Day -1 and will may be 
discharged after all assessments have been completed on Day 3.   Subjects may remain inpatient 
up to Day 15 to improve visit compliance, at the discretion of the investigator.   
6.2.  Exclusion Criteria 
[26] 
have a history or show evidence of active tuberculosis (TB) as documented by 
based on medical history and examination, chest x-rays (posterior anterior and 
lateral), and TB testing (positive [not indeterminate] T-SPOT® TB test).  One 
repeat of the T-SPOT® TB test is permitted following an indeterminate result.  For 
more details, see Section 9.5.7. 
7.1.  Treatments Administered 
Investigational product doses and formulations are summarized in Table CGAY.2.  Further 
details for the preparation of all investigational products will be provided in the pharmacy 
manual. 
… 
The prefilled syringe (PFS) of galcanezumab or placebo (excipients only) for injection should be 
stored in the refrigerator (2 to 8°C).  The PFS should be removed from the refrigerated storage 
and allowed to equilibrate to room temperature for approximately 30 minutes before 
administration. 
Injections will be administered by the clinical staff in the abdomen.  The subjects and clinical 
site staff (except pharmacist) will be blinded to the treatment; the pharmacist and sponsor will be 
unblinded.   The dose volumes and number of injections for subjects in each cohort are presented 
in Table CGAY.2. 
Galcanezumab or placebo will be administered as SC injections into the abdomen while the 
subject is in a sitting position.  The location of the injection(s) will be recorded.  Multiple 
injections making up a single dose (i.e. for Cohort B) should be apart from each other, so ISRs, if 
any, can be observed separately.  Subjects should may stay in the semi-recumbent position for 
4 hours following study drug administration, where possible. 
7.2.  Method of Treatment Assignment 
Subjects who meet the study entry criteria will be randomized to receive either galcanezumab or 
placebo in a 4:1 ratio via a computer-generated random sequence using an interactive 
web-response system (IWRS). 
7.3.  Blinding 
This will be a subject- and investigator-blinded study.  The subjects and clinical staff (except 
pharmacist) will be blinded to which treatment (galcanezumab or placebo) the subjects are 
assigned to.  The pharmacist and the sponsor will be unblinded.     

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Galcanezumab (LY2951742) 
Emergency codes will be available to the investigator.  A code, which reveals the treatment for a 
specific study subject, may be opened during the study only if the subject’s well-being requires 
knowledge of the subject’s treatment assignment.Emergency unblinding for AEs may be 
performed through the IWRS, which may supplement or take the place of emergency codes 
generated by a computer drug-labeling system.  This option may be used ONLY if the subject’s 
well-being requires knowledge of the subject’s treatment assignment.  All calls resulting in an 
unblinding event are recorded and reported by the IWRS. 
In case of an emergency, the investigator has the sole responsibility for determining if unblinding 
of a subject’s treatment assignment is warranted for medical management of the event.   The 
subject’s safety must always be the first consideration in making such a determination.   If the 
investigator decides that unblinding is warranted, it is the responsibility of the investigator to 
promptly document the decision and rationale and notify Lilly as soon as possible. 
Upon completion of the study, all codes must be returned to Lilly or its designee. 
7.5.  Preparation/Handling/Storage/Accountability 
The packaged investigational product must be stored according to the storage requirements 
printed onto the packaging label.   
To administer the galcanezumab injections, the investigational sites are to refer to the pharmacy 
binder for the preparation and handling instructions of the packaged investigational product. 
9.5.1.  Laboratory Tests 
With the exception of safety laboratory test results that may unblind the study, Lilly or its 
designee will provide the investigator with the results of laboratory tests analyzed by a central 
vendor, if a central vendor is used for the study All safety laboratory tests will be conducted at a 
local laboratory. 
9.5.7.  Tuberculosis Testing 
Subjects will be tested as indicated in the Schedule of Activities (Section 2) for evidence of 
active TB, which includes a T-SPOT® TB test.  If the first test result is indeterminate, 1 repeat is 
allowed.  If the repeat result is indeterminate, the subject will be excluded from the study.  
Subjects who have had household contact with a person with active TB must be excluded unless 
appropriate and documented prophylaxis treatment for TB has been completed.  Subjects with 
any history of active TB are excluded from the study, regardless of previous or current TB 
treatments. 
10.3.2.2.  Statistical Evaluation of Safety 
Safety parameters that will be assessed include safety lab parameters and, vital signs, and ECG 
parameters. 

I5Q-MC-CGAY(a) Clinical Pharmacology Protocol
Page 50
Galcanezumab (LY2951742)
Appendix 2.  Clinical Laboratory Tests

A ‘T-SPOT® TB test’ was added to the table to be performed at screening only. 

The abbreviation ‘TB = tuberculosis’ was added to the abbreviation footnote.

Footnote ‘a’ was updated as follows: 
a Day -1 tests to be conducted by the local laboratory; other scheduled assessments to be conducted at a 
central laboratory All safety laboratory tests will be conducted by the local laboratory.
Appendix 4.  Blood Sampling Summary
Protocol I5Q-MC-CGAY Sampling Summary
Purpose
Maximum Blood Volume 
per Sample (mL)
Maximum Number 
of Blood Samples
Maximum Total 
Volume (mL)
Screening testsa
45 28
1
45 28
Clinical laboratory testsa
9 8
6
54 48
Galcanezumab Pharmacokineticsb
2.5
17
42.5
Immunogenicityb
10
6
60
Pharmacogenetics
10
1
10
Total
211.5 188.5
Total for clinical purposes [rounded up to nearest 10 mL]
220 190
a
Additional samples may be drawn if needed for safety purposes.
b
Additional samples may be drawn in the event of hypersensitivity reactions.

Leo Document ID = 9aabaeb2-88e9-4f35-9d7e-bb6fa41179f1
Approver: 
Approval Date & Time: 09-Apr-2019 18:41:48 GMT
Signature meaning: Approved
Approver: 
Approval Date & Time: 09-Apr-2019 19:35:49 GMT
Signature meaning: Approved
PPD
PPD