Trial Outcomes & Findings for A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants (NCT NCT04840901)

NCT ID: NCT04840901

Last Updated: 2024-11-22

Results Overview

PK: Cmax of Lebrikizumab

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

242 participants

Primary outcome timeframe

Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99

Results posted on

2024-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) 2-milliliters (mL) (125 milligrams per milliliter \[mg/mL\]) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).	Lebrikizumab (Test) - Autoinjector (AI) 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).
Overall Study STARTED	123	119
Overall Study Received at Least One Dose of Study Drug	122	119
Overall Study COMPLETED	118	117
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) 2-milliliters (mL) (125 milligrams per milliliter \[mg/mL\]) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).	Lebrikizumab (Test) - Autoinjector (AI) 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).
Overall Study Lost to Follow-up	3	1
Overall Study Moved	1	0
Overall Study Unable to comply with study schedule	0	1
Overall Study Screen Failure - Randomized but Did Not Receive Study Drug	1	0

Baseline Characteristics

A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) n=122 Participants 2-mL (125 mg/mL) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).	Lebrikizumab (Test) - Autoinjector (AI) n=119 Participants 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).	Total n=241 Participants Total of all reporting groups
Age, Continuous	45.2 years STANDARD_DEVIATION 12.6 • n=39 Participants	44.1 years STANDARD_DEVIATION 13.2 • n=41 Participants	44.7 years STANDARD_DEVIATION 12.9 • n=35 Participants
Sex: Female, Male Female	73 Participants n=39 Participants	64 Participants n=41 Participants	137 Participants n=35 Participants
Sex: Female, Male Male	49 Participants n=39 Participants	55 Participants n=41 Participants	104 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=39 Participants	30 Participants n=41 Participants	50 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	102 Participants n=39 Participants	88 Participants n=41 Participants	190 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	1 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=39 Participants	1 Participants n=41 Participants	3 Participants n=35 Participants
Race (NIH/OMB) Asian	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	28 Participants n=39 Participants	27 Participants n=41 Participants	55 Participants n=35 Participants
Race (NIH/OMB) White	91 Participants n=39 Participants	90 Participants n=41 Participants	181 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United States	122 Participants n=39 Participants	119 Participants n=41 Participants	241 Participants n=35 Participants

PRIMARY outcome

Timeframe: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99

Population: All participants who received a full dose of Lebrikizumab and had evaluable PK sample.

PK: Cmax of Lebrikizumab

Outcome measures

Outcome measures
Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) n=120 Participants 2-mL (125 mg/mL) Lebrikizumab administered SC via pre-filled syringe with needle safety device (PFS-NSD).	Lebrikizumab (Test) - Autoinjector (AI) n=118 Participants 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab	38.5 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 31	41.9 micrograms per milliliter (µg/mL) Geometric Coefficient of Variation 31

PRIMARY outcome

Timeframe: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99

Population: All participants who received a full dose of Lebrikizumab and had evaluable PK sample.

PK: AUC\[0-∞\] of Lebrikizumab

Outcome measures

Outcome measures
Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) n=106 Participants 2-mL (125 mg/mL) Lebrikizumab administered SC via pre-filled syringe with needle safety device (PFS-NSD).	Lebrikizumab (Test) - Autoinjector (AI) n=100 Participants 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab	1340 microgramsday per milliliter (µgd/mL) Geometric Coefficient of Variation 29	1450 microgramsday per milliliter (µgd/mL) Geometric Coefficient of Variation 26

PRIMARY outcome

Timeframe: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99

Population: All participants who received a full dose of Lebrikizumab and had evaluable PK sample.

PK: AUC\[0-tlast\] of Lebrikizumab

Outcome measures

Outcome measures
Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) n=117 Participants 2-mL (125 mg/mL) Lebrikizumab administered SC via pre-filled syringe with needle safety device (PFS-NSD).	Lebrikizumab (Test) - Autoinjector (AI) n=117 Participants 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab	1250 µg*d/mL Geometric Coefficient of Variation 28	1360 µg*d/mL Geometric Coefficient of Variation 25

Adverse Events

Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD)

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Lebrikizumab (Test) - Autoinjector (AI)

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-595-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Other adverse events
Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) n=122 participants at risk 2-mL (125 mg/mL) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).	Lebrikizumab (Test) - Autoinjector (AI) n=119 participants at risk 2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).
Eye disorders Vision blurred	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Abdominal discomfort	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Change of bowel habit	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Diarrhoea	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 3/119 • Number of events 3 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Faeces discoloured	1.6% 2/122 • Number of events 2 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Nausea	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 3/119 • Number of events 3 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Oral disorder	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Retching	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Gastrointestinal disorders Vomiting	1.6% 2/122 • Number of events 2 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.7% 2/119 • Number of events 2 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Influenza like illness	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site erythema	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site haemorrhage	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site induration	1.6% 2/122 • Number of events 2 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site pruritus	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site reaction	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 3/119 • Number of events 3 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Injection site warmth	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Non-cardiac chest pain	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Oedema peripheral	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pain	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.7% 2/119 • Number of events 2 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Pyrexia	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.7% 2/119 • Number of events 2 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Ulcer	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
General disorders Vessel puncture site reaction	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Immune system disorders Allergy to arthropod sting	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations COVID-19	5.7% 7/122 • Number of events 7 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	2.5% 3/119 • Number of events 3 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Conjunctivitis	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Hordeolum	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Lower respiratory tract infection	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Nasopharyngitis	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Pharyngitis	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Tinea versicolour	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Upper respiratory tract infection	1.6% 2/122 • Number of events 2 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Urinary tract infection	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Viral infection	1.6% 2/122 • Number of events 2 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Infections and infestations Vulvovaginitis	0.00% 0/73 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	1.6% 1/64 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Arthropod sting	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Skin abrasion	1.6% 2/122 • Number of events 2 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Skin laceration	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Tooth fracture	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Injury, poisoning and procedural complications Wound	0.82% 1/122 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.00% 0/119 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Investigations Alanine aminotransferase increased	0.00% 0/122 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.	0.84% 1/119 • Number of events 1 • Up to 99 days All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.