Trial Outcomes & Findings for A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants (NCT NCT04194892)

NCT ID: NCT04194892

Last Updated: 2026-07-13

Results Overview

Pharmacokinetic (PK): maximum drug concentration (Cmax) of Pegilodecakin.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose)

Results posted on

2026-07-13

Participant Flow

2-way crossover study with 7 days washout period between doses.

Participant milestones

Participant milestones
Measure	Sequence 1 Period 1: Participants received Pegilodecakin subcutaneous (SQ) doses of 0.8 milligrams (mg) at 4 milligrams per milliliter (mg/mL) administered as 0.2 mL injections from a vial drawn into a conventional syringe. Period 2: Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a pre-filled syringe.	Sequence 2 Period 1: Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a pre-filled syringe. Period 2: Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a vial drawn into a conventional syringe.
Period 1 STARTED	6	6
Period 1 Received at Least 1 Dose of Study Drug	6	6
Period 1 COMPLETED	6	6
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	6	6
Period 2 Received at Least 1 Dose of Study Drug	6	6
Period 2 COMPLETED	6	6
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Crossover Study to Evaluate Pegilodecakin (LY3500518) in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence 1 n=6 Participants Period 1: Participants received pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a vial drawn into a conventional syringe. Period 2: Participants received pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a pre-filled syringe.	Sequence 2 n=6 Participants Period 1: Participants received pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a pre-filled syringe. Period 2: Participants received pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a vial drawn into a conventional syringe	Total n=12 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	2 Participants n=20 Participants	2 Participants n=20 Participants	4 Participants n=40 Participants
Age, Continuous	35.2 years STANDARD_DEVIATION 7.65 • n=20 Participants	33.7 years STANDARD_DEVIATION 9.27 • n=20 Participants	34.4 years STANDARD_DEVIATION 8.14 • n=40 Participants
Sex: Female, Male Female	2 Participants n=20 Participants	4 Participants n=20 Participants	6 Participants n=40 Participants
Sex: Female, Male Male	4 Participants n=20 Participants	2 Participants n=20 Participants	6 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=20 Participants	3 Participants n=20 Participants	6 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=20 Participants	3 Participants n=20 Participants	6 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) White	4 Participants n=20 Participants	4 Participants n=20 Participants	8 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Region of Enrollment United States	6 Participants n=20 Participants	6 Participants n=20 Participants	12 Participants n=40 Participants

PRIMARY outcome

Timeframe: Period 1: Days 1 to 4 and Day 8 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose (Day 8-predose)), Period 2: Days 8 to 11 and Day 15 (Predose, 2, 4, 8, 12, 16, 24, 36, 48, 72, and 168 hours post-dose)

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Pharmacokinetic (PK): maximum drug concentration (Cmax) of Pegilodecakin.

Outcome measures

Outcome measures
Measure	Pegilodecakin Vial n=11 Participants Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a vial drawn into a conventional syringe.	Pegilodecakin Pre-filled Syringe (PFS) n=12 Participants Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a pre-filled syringe.
Pharmacokinetic (PK): Maximum Drug Concentration (Cmax) of Pegilodecakin	9050 picogram per milliliter (pg/mL) Geometric Coefficient of Variation 93.7	12000 picogram per milliliter (pg/mL) Geometric Coefficient of Variation 111

PRIMARY outcome

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

Time of maximum serum concentration (Tmax) of Pegilodecakin.

Outcome measures

Outcome measures
Measure	Pegilodecakin Vial n=11 Participants Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a vial drawn into a conventional syringe.	Pegilodecakin Pre-filled Syringe (PFS) n=12 Participants Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a pre-filled syringe.
PK: Time of Maximum Concentration (Tmax) of Pegilodecakin	12.00 hours Interval 8.0 to 24.0	12.00 hours Interval 4.0 to 16.05

PRIMARY outcome

Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.

PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC\[0-inf\] of Pegilodecakin.

Outcome measures

Outcome measures
Measure	Pegilodecakin Vial n=11 Participants Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a vial drawn into a conventional syringe.	Pegilodecakin Pre-filled Syringe (PFS) n=11 Participants Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL administered as 0.2 mL injections from a pre-filled syringe.
PK: Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity AUC[0-inf] of Pegilodecakin	304000 hourpicogram per milliliter (hpg/mL) Geometric Coefficient of Variation 66.6	457000 hourpicogram per milliliter (hpg/mL) Geometric Coefficient of Variation 62.8

Adverse Events

Pegilodecakin Vial

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Pegilodecakin Pre-filled Syringe (PFS)

Serious events: 0 serious events

Other events: 11 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: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI may not disclose any articles or make any presentations related to the services provided by sponsor here under with respect to a project or referring to data, information or materials generated as part of the services without the prior written consent of sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Pegilodecakin Vial n=12 participants at risk Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL were administered as 0.2 mL injections from a vial drawn into a conventional syringe.	Pegilodecakin Pre-filled Syringe (PFS) n=12 participants at risk Participants received Pegilodecakin SQ doses of 0.8 mg at 4 mg/mL were administered as 0.2 mL injections from a pre-filled syringe.
General disorders Injection site reaction right upper quadrant injection site streaking	16.7% 2/12 • Number of events 2 • Up To 15 days All randomized participants who received at least one dose of study drug.	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.
General disorders Injection site reaction right upper quadrant pruritus	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain chest	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain left arm	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.
Nervous system disorders Headache	33.3% 4/12 • Number of events 4 • Up To 15 days All randomized participants who received at least one dose of study drug.	41.7% 5/12 • Number of events 6 • Up To 15 days All randomized participants who received at least one dose of study drug.
Nervous system disorders Lightheadedness	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Acne aggravated	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.
Eye disorders Watery eyes	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal discomfort	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	25.0% 3/12 • Number of events 3 • Up To 15 days All randomized participants who received at least one dose of study drug.	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.
General disorders Injection site reaction right lower quadrant erythema	33.3% 4/12 • Number of events 4 • Up To 15 days All randomized participants who received at least one dose of study drug.	41.7% 5/12 • Number of events 5 • Up To 15 days All randomized participants who received at least one dose of study drug.
General disorders Injection site reaction right lower quadrant hyperpigmentation	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.
General disorders Injection site reaction right lower quadrant pruritis	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.
General disorders Injection site reaction right lower quadrant pruritus	16.7% 2/12 • Number of events 2 • Up To 15 days All randomized participants who received at least one dose of study drug.	25.0% 3/12 • Number of events 3 • Up To 15 days All randomized participants who received at least one dose of study drug.
General disorders Injection site reaction right upper quadrant erythema	41.7% 5/12 • Number of events 5 • Up To 15 days All randomized participants who received at least one dose of study drug.	41.7% 5/12 • Number of events 5 • Up To 15 days All randomized participants who received at least one dose of study drug.
General disorders Injection site reaction right upper quadrant hyperpigmentation	0.00% 0/12 • Up To 15 days All randomized participants who received at least one dose of study drug.	8.3% 1/12 • Number of events 1 • Up To 15 days All randomized participants who received at least one dose of study drug.