Trial Outcomes & Findings for A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants (NCT NCT06475729)

NCT ID: NCT06475729

Last Updated: 2025-12-30

Results Overview

Cmax of Mirikizumab is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 498 participants
• Primary outcome timeframe: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
• Results posted on: 2025-12-30

Participant Flow

Participant milestones

Measure	200 mg Mirikizumab (Reference) Participants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
Overall Study STARTED	249	249
Overall Study All Participants Who Were Exposed to Study Intervention (Safety Population)	240	244
Overall Study COMPLETED	237	241
Overall Study NOT COMPLETED	12	8

Reasons for withdrawal

Measure	200 mg Mirikizumab (Reference) Participants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
Overall Study Withdrawal by Subject	2	1
Overall Study Randomized but did not receive any dose	3	2
Overall Study Lost to Follow-up	1	2
Overall Study Physician Decision	5	2
Overall Study Adverse Event	1	1

Baseline Characteristics

A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants

Baseline characteristics by cohort

Measure	200 mg Mirikizumab (Reference) n=240 Participants Participants received 200 mg mirikizumab reference formulation, 2 × 1-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) n=244 Participants Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	Total n=484 Participants Total of all reporting groups
Age, Continuous	42.7 years STANDARD_DEVIATION 11.6 • n=174 Participants	42.4 years STANDARD_DEVIATION 12.5 • n=166 Participants	42.5 years STANDARD_DEVIATION 12.1 • n=167 Participants
Sex: Female, Male Female	112 Participants n=174 Participants	135 Participants n=166 Participants	247 Participants n=167 Participants
Sex: Female, Male Male	128 Participants n=174 Participants	109 Participants n=166 Participants	237 Participants n=167 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	111 Participants n=174 Participants	108 Participants n=166 Participants	219 Participants n=167 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	129 Participants n=174 Participants	136 Participants n=166 Participants	265 Participants n=167 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants	1 Participants n=166 Participants	1 Participants n=167 Participants
Race (NIH/OMB) Asian	8 Participants n=174 Participants	10 Participants n=166 Participants	18 Participants n=167 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants	1 Participants n=166 Participants	1 Participants n=167 Participants
Race (NIH/OMB) Black or African American	52 Participants n=174 Participants	56 Participants n=166 Participants	108 Participants n=167 Participants
Race (NIH/OMB) White	177 Participants n=174 Participants	174 Participants n=166 Participants	351 Participants n=167 Participants
Race (NIH/OMB) More than one race	3 Participants n=174 Participants	2 Participants n=166 Participants	5 Participants n=167 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants
Region of Enrollment United States	240 Participants n=174 Participants	244 Participants n=166 Participants	484 Participants n=167 Participants

PRIMARY outcome

Timeframe: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

Population: All enrolled participants who received a full dose of study intervention and have evaluable PK data for this outcome according to the study intervention actually received.

Cmax of Mirikizumab is reported.

Outcome measures

Measure	200 mg Mirikizumab (Reference) n=238 Participants Participants received 200 mg mirikizumab reference formulation, 2 × 1-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) n=243 Participants Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab	12.9 microgram per milliliter (ug/mL) Geometric Coefficient of Variation 40	13.5 microgram per milliliter (ug/mL) Geometric Coefficient of Variation 39

PRIMARY outcome

Timeframe: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

Population: All enrolled participants who received a full dose of study intervention and have evaluable PK data for this outcome according to the study intervention actually received.

AUC [0-∞] of Mirikizumab is reported.

Outcome measures

Measure	200 mg Mirikizumab (Reference) n=238 Participants Participants received 200 mg mirikizumab reference formulation, 2 × 1-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) n=243 Participants Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab	225 microgram*day per milliliter (ug*day/mL) Geometric Coefficient of Variation 41	228 microgram*day per milliliter (ug*day/mL) Geometric Coefficient of Variation 41

PRIMARY outcome

Timeframe: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

Population: All enrolled participants who received a full dose of study intervention and have evaluable PK data for this outcome according to the study intervention actually received.

AUC [0 to tlast] of Mirikizumab is reported.

Outcome measures

Measure	200 mg Mirikizumab (Reference) n=238 Participants Participants received 200 mg mirikizumab reference formulation, 2 × 1-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) n=241 Participants Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab	220 microgram*day per milliliter (ug*day/mL) Geometric Coefficient of Variation 40	223 microgram*day per milliliter (ug*day/mL) Geometric Coefficient of Variation 41

Adverse Events

200 mg Mirikizumab (Reference)

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

200 mg Mirikizumab (Test)

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	200 mg Mirikizumab (Reference) n=240 participants at risk Participants received 200 mg mirikizumab reference formulation, 2 × 1-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.	200 mg Mirikizumab (Test) n=244 participants at risk Participants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
Ear and labyrinth disorders Ear pain	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Cardiac disorders Angina pectoris	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Cardiac disorders Palpitations	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Gastrointestinal disorders Abdominal discomfort	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Gastrointestinal disorders Abdominal pain	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Gastrointestinal disorders Constipation	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Gastrointestinal disorders Diarrhoea	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Gastrointestinal disorders Gastritis	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Gastrointestinal disorders Haemorrhoids	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Gastrointestinal disorders Nausea	1.2% 3/240 • Number of events 4 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Gastrointestinal disorders Toothache	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Gastrointestinal disorders Vomiting	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Chest pain	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Chills	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Fatigue	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Injection site bruising	0.83% 2/240 • Number of events 3 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Injection site pain	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Injection site reaction	1.7% 4/240 • Number of events 6 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	2.0% 5/244 • Number of events 5 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Pain	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Peripheral swelling	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Pyrexia	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
General disorders Vessel puncture site bruise	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Hepatobiliary disorders Hepatitis	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Immune system disorders Hypersensitivity	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Cellulitis	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Covid-19	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Escherichia urinary tract infection	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Furuncle	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Gastroenteritis	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Pharyngitis	1.2% 3/240 • Number of events 3 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Pharyngitis streptococcal	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Rhinitis	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Tooth infection	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Infections and infestations Upper respiratory tract infection	1.7% 4/240 • Number of events 4 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Ankle fracture	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Arthropod bite	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Clavicle fracture	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Contusion	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Hand fracture	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Ligament sprain	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Limb injury	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Pulmonary contusion	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Road traffic accident	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Injury, poisoning and procedural complications Skin laceration	0.42% 1/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Investigations Alanine aminotransferase increased	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Investigations Aspartate aminotransferase increased	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Investigations Blood potassium increased	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Investigations Sars-cov-2 test positive	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Metabolism and nutrition disorders Decreased appetite	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Metabolism and nutrition disorders Dehydration	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Metabolism and nutrition disorders Hyperkalaemia	1.2% 3/240 • Number of events 4 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Musculoskeletal and connective tissue disorders Back pain	1.7% 4/240 • Number of events 4 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Musculoskeletal and connective tissue disorders Myalgia	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Nervous system disorders Dizziness	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Nervous system disorders Headache	3.8% 9/240 • Number of events 9 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	4.9% 12/244 • Number of events 14 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Nervous system disorders Loss of consciousness	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Nervous system disorders Paraesthesia	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Nervous system disorders Syncope	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Psychiatric disorders Abnormal dreams	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Psychiatric disorders Insomnia	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Respiratory, thoracic and mediastinal disorders Cough	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.82% 2/244 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.2% 3/240 • Number of events 3 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Respiratory, thoracic and mediastinal disorders Sneezing	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Skin and subcutaneous tissue disorders Dermatitis contact	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Skin and subcutaneous tissue disorders Rash	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Skin and subcutaneous tissue disorders Urticaria	0.42% 1/240 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Vascular disorders Hypertension	0.83% 2/240 • Number of events 2 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.00% 0/244 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.
Vascular disorders Hypotension	0.00% 0/240 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.	0.41% 1/244 • Number of events 1 • Baseline up to Day 74 All participants who were exposed to study intervention (Safety Population). Participants were analyzed according to the intervention they actually received.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 08005455979

Email: ClinicalTrials.gov@lilly.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60