Trial Outcomes & Findings for A Phase I Study of LY3502970 in Healthy Participants (NCT NCT06085482)

Results Overview

Absolute bioavailability of LY3502970, expressed in percentage, was estimated using the AUC(0-∞) values from each individual participant based on IV dosed \[14C\]-LY3502970 compared to oral dosed LY3502970, using formula: \[AUC0-∞(oral) x Dose (IV) divided by AUC0-∞(IV) x Dose (oral)\] x100. The sampling time points from pre-oral dose through 186 hours post-IV dose were used to assess this outcome.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose; 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose.

Results posted on

2026-05-27

Participant Flow

Participant milestones

Participant milestones
Measure	LY3502970 + [14C]-LY3502970 Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 (\[14C\]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity.
Overall Study STARTED	10
Overall Study Received LY3502970	10
Overall Study Received [14C]-LY3502970	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LY3502970 + [14C]-LY3502970 Participants received a single oral dose of 1 milligram (mg) LY3502970 followed six hours later by an intravenous (IV) dose of approximately 21 microgram (μg) of LY3502970 radiolabeled with carbon-14 (\[14C\]-LY3502970) containing approximately 800 nanocurie (nCi) radioactivity.
Overall Study Adverse Event	1

Baseline Characteristics

A Phase I Study of LY3502970 in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LY3502970 + [14C]-LY3502970 n=10 Participants Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.
Age, Continuous	52.4 years STANDARD_DEVIATION 13 • n=51 Participants
Sex: Female, Male Female	5 Participants n=51 Participants
Sex: Female, Male Male	5 Participants n=51 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=51 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=51 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=51 Participants
Race (NIH/OMB) Asian	0 Participants n=51 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=51 Participants
Race (NIH/OMB) Black or African American	3 Participants n=51 Participants
Race (NIH/OMB) White	7 Participants n=51 Participants
Race (NIH/OMB) More than one race	0 Participants n=51 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=51 Participants

PRIMARY outcome

Timeframe: Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose; 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose.

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

Absolute bioavailability of LY3502970, expressed in percentage, was estimated using the AUC(0-∞) values from each individual participant based on IV dosed \[14C\]-LY3502970 compared to oral dosed LY3502970, using formula: \[AUC0-∞(oral) x Dose (IV) divided by AUC0-∞(IV) x Dose (oral)\] x100. The sampling time points from pre-oral dose through 186 hours post-IV dose were used to assess this outcome.

Outcome measures

Outcome measures
Measure	LY3502970 + [14C]-LY3502970 n=10 Participants Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.
Pharmacokinetics (PK): Absolute Bioavailability of LY3502970	77 Percentage Geometric Coefficient of Variation 27

SECONDARY outcome

Timeframe: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose

Population: All participants who received at least 1 dose of study drug and had evaluable PK data.

PK: AUC \[0-∞\] of Total Radioactivity in Plasma.

Outcome measures

Outcome measures
Measure	LY3502970 + [14C]-LY3502970 n=10 Participants Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.
PK: Area Under the Curve Concentration Versus Time Curve From Zero to Infinity (AUC [0-∞]) of Total Radioactivity in Plasma	3.71 nanogram equivalent*hour per milliliter Geometric Coefficient of Variation 29

SECONDARY outcome

Timeframe: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose

Population: All participants who received at least 1 dose of study drug and had evaluable PK data.

PK: AUC \[0-∞\] of \[14C\]-LY3502970 in Plasma.

Outcome measures

Outcome measures
Measure	LY3502970 + [14C]-LY3502970 n=10 Participants Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.
PK: AUC [0-∞] of [14C]-LY3502970 in Plasma	2.91 nanogram equivalent*hour per milliliter Geometric Coefficient of Variation 19

SECONDARY outcome

Timeframe: Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose

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

PK: AUC \[0-∞\] of LY3502970 in Plasma.

Outcome measures

Outcome measures
Measure	LY3502970 + [14C]-LY3502970 n=10 Participants Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.
PK: AUC [0-∞] of LY3502970 in Plasma	108 nanogram*hour per milliliter Geometric Coefficient of Variation 35

SECONDARY outcome

Timeframe: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138 hours post-IV dose

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

PK: Cmax of Total Radioactivity in Plasma.

Outcome measures

Outcome measures
Measure	LY3502970 + [14C]-LY3502970 n=10 Participants Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.
PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma	2.10 nanogram equivalent per milliliter Geometric Coefficient of Variation 59

SECONDARY outcome

Timeframe: 0 (immediately after IV dosing), 2, 5, 10, 15 minutes and 0.5, 1, 2, 4, 6, 10, 18, 30, 42, 66, 90, 114, 138, 162, 186 hours post-IV dose

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

PK: Cmax of \[14C\]-LY3502970 in Plasma.

Outcome measures

Outcome measures
Measure	LY3502970 + [14C]-LY3502970 n=10 Participants Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.
PK: Cmax of [14C]-LY3502970 in Plasma	2.08 nanogram equivalent per milliliter Geometric Coefficient of Variation 53

SECONDARY outcome

Timeframe: Pre-oral dose, 0.5, 1, 2, 4, 6, 6.5, 7, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120 hours post-oral dose

Population: All participants who received at least 1 dose of study drug and had evaluable PK data.

PK: Cmax of LY3502970 in Plasma.

Outcome measures

Outcome measures
Measure	LY3502970 + [14C]-LY3502970 n=10 Participants Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.
PK: Cmax of LY3502970 in Plasma	5.43 nanogram per milliliter Geometric Coefficient of Variation 42

Adverse Events

LY3502970 + [14C]-LY3502970

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LY3502970 + [14C]-LY3502970 n=10 participants at risk Participants received a single oral dose of 1 mg LY3502970 followed six hours later by an intravenous dose of approximately 21 μg of \[14C\]-LY3502970 containing approximately 800 nCi radioactivity.
General disorders Vessel puncture site pain	10.0% 1/10 • Number of events 1 • Baseline through end of the follow-up (Up to Day 19) All participants who received at least one dose of study drug.
Infections and infestations COVID-19	10.0% 1/10 • Number of events 1 • Baseline through end of the follow-up (Up to Day 19) All participants who received at least one dose of study drug.
Nervous system disorders Headache	10.0% 1/10 • Number of events 1 • Baseline through end of the follow-up (Up to Day 19) All participants who received at least one dose of study drug.

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: GT60