Trial Outcomes & Findings for A Study of LY3316531 in Healthy Participants (NCT NCT03611608)

Last Updated: 2024-08-20

Results Overview

To assess target neutralization of calcitonin gene-related peptide by LY3316531 versus placebo, the capsaicin-induced dermal blood flow was measured at baseline (before administration of LY3316531 or placebo) as well as 24 days after a single intravenous dose of LY3316531 or placebo

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

Baseline, Day 24

Results posted on

2024-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo as a single saline intravenous (IV) infusion. Capsaicin-induced Dermal Blood Flow (DBF): Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.	300 Milligram (mg) LY3316531 Participants received a single 300 milligram (mg) LY3316531 IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin \[1000 microgram (µg)/20 microliter (µL)\] applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.
Overall Study STARTED	4	12
Overall Study Received at Least One Dose/Injection	4	12
Overall Study COMPLETED	4	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of LY3316531 in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=4 Participants Participants received placebo as a single saline IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin \[1000 microgram (µg)/20 microliter (µL)\] applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.	300 mg LY3316531 n=12 Participants Participants received a single 300 mg LY3316531 IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.	Total n=16 Participants Total of all reporting groups
Age, Continuous	41.0 years STANDARD_DEVIATION 7.7 • n=5 Participants	26.6 years STANDARD_DEVIATION 8.5 • n=7 Participants	30.2 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Belgium	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 24

Population: All participants who received at least one injection of LY3316531 or Placebo.

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Participants received placebo as a single saline IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.	300 mg LY3316531 n=12 Participants Participants received a single 300 mg LY3316531 IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.
Change From Baseline in Capsaicin-Induced Dermal Blood Flow Following LY3316531 Compared to Placebo	327.19 milliliter/100gram/minute (mL/100g/min) Standard Deviation 67.02	63.65 milliliter/100gram/minute (mL/100g/min) Standard Deviation 53.31

SECONDARY outcome

Timeframe: Pre-dose, end of infusion (30min), and 2 hours (h), 6h, 24h, 10 days, 24 days, 38 days, 52 days, 66 days and 80 days post-dose

Population: All participants who received an injection of LY3316531 and contributed PK samples for analysis.

Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531 was reported.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo as a single saline IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.	300 mg LY3316531 Participants received a single 300 mg LY3316531 IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.
Pharmacokinetics: Maximum Concentration (Cmax) of LY3316531	88.2 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 15	—

SECONDARY outcome

Timeframe: Pre-dose, end of infusion (30min), and 2 hours (h), 6h, 24h, 10 days, 24 days, 38 days, 52 days, 66 days and 80 days post-dose

Population: All participants who received an injection of LY3316531 and contributed PK samples for analysis.

Pharmacokinetics: Area Under Drug Concentration-Time Curve From Zero to Infinity (AUC\[0 ∞\]) of LY3316531 was reported

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received placebo as a single saline IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.	300 mg LY3316531 Participants received a single 300 mg LY3316531 IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.
Pharmacokinetics: Area Under Drug Concentration-Time Curve From Zero to Infinity (AUC[0 ∞]) of LY3316531	42200 microgramhour per milliliter (µgh/mL) Geometric Coefficient of Variation 16	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

300 mg LY3316531

Serious events: 0 serious events

Other events: 9 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
Publication restrictions are in place

Restriction type: LTE60

Measure	Placebo n=4 participants at risk Participants received placebo as a single saline IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.	300 mg LY3316531 n=12 participants at risk Participants received a single 300 mg LY3316531 IV infusion. Capsaicin-induced DBF: Topical doses of 20 microliter (µL) capsaicin (1000 microgram (µg)/20 µL) applied to 2 different locations on the participant's forearm to induce an increase in dermal blood flow. A 20 µL topical dose of vehicle was applied to a third location on the forearm.
Blood and lymphatic system disorders Leukocytosis	25.0% 1/4 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	0.00% 0/12 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Eye disorders Eyelid skin dryness	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
General disorders Chest discomfort	25.0% 1/4 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	0.00% 0/12 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
General disorders Fatigue	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
General disorders Infusion site reaction	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Infections and infestations Angular cheilitis	25.0% 1/4 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	0.00% 0/12 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Infections and infestations Body tinea	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Infections and infestations Nasopharyngitis	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	33.3% 4/12 • Number of events 5 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Infections and infestations Pyuria	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Infections and infestations Tinea pedis	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Infections and infestations Upper respiratory tract infection	25.0% 1/4 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	16.7% 2/12 • Number of events 2 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Injury, poisoning and procedural complications Stress fracture	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	0.00% 0/12 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	25.0% 1/4 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	0.00% 0/12 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.
Skin and subcutaneous tissue disorders Papule	0.00% 0/4 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.	8.3% 1/12 • Number of events 1 • Up To 167 days All participants who received at least one injection of LY3316531 or Placebo.