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A Study of LY3463251 in Healthy Participants

A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight Healthy Subjects

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03764774
Enrollment
118
Registered
2018-12-05
Start date
2018-12-06
Completion date
2020-12-07
Last updated
2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen. This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.

Interventions

DRUGLY3463251

Administered SC

DRUGPlacebo

Administered SC

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy males and females

Exclusion criteria

* Diagnosed with Type 1 or Type 2 diabetes * Women who are of childbearing potential or who are breastfeeding * Donated blood of more than 500 millilitres (mL) within the previous 3 months of study screening * Have used any tobacco product within 3 months of Day -1, or are unwilling to refrain from the use of tobacco during the study

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With One or More Adverse Event(s) (AEs), All CausalitiesBaseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary

MeasureTime frameDescription
PK: Maximum Observed Concentration of LY3463251 Part BDay 1: Predose, 6, 12, 24, 48, 72, and 120 hours (hr) postdose; Day 8: Predose; Day 15: Predose; Day 28: Predose; Day 57: Predose; Day 78: Predose, and Day 79: 24 hr postdosePK: Cmax of LY3463251
PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part ADay 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdosePK: AUC versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LY3463251.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part ADay 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdosePK: Cmax of LY3463251
Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BPD: Day -2; Predose: Day 30 and Day 85 (Part B)AUC of glucose was analyzed using a model with treatment + Day + Treatment\*Day + Subject + Random Error where Subject is fitted as a random effect and a repeated statement used with an Unstructured covariance structure.
Change From Baseline in Body Weight at Day 85 Part BBaseline, Day 85 (Part B)Change from Baseline in Body Weight
PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part BDay 1: Predose, 6, 12, 24, 48, 72, 120, and 168 hours (hr) postdose: Day 78: Predose, 24, 48, 168, 336, 696, 1080 hr postdosePK: AUC(0-tau) of LY3463251 during one dosing interval on Day 1 and Day 78.

Countries

United States

Participant flow

Recruitment details

Cohort 4 was terminated early because data from previous cohorts suggested a low probability of achieving competitive weight loss at tolerable doses.

Participants by arm

ArmCount
Placebo Single Dose
Single dose of placebo administered SC on Day 1
16
0.01 Milligram (mg) LY3463251 Part A Cohort 1
Single dose of 0.01 mg LY3463251 administered SC on Day 1.
6
0.03 mg LY3463251 Part A Cohort 2
Single dose of 0.03 mg LY3463251 administered SC on Day 1.
6
0.1 mg LY3463251 Part A Cohort 3
Single dose of 0.1 mg LY3463251 administered SC on Day 1.
6
0.3 mg LY3463251 Part A Cohort 4
Single dose of 0.3 mg LY3463251 administered SC on Day 1.
6
1 mg LY3463251 Part A Cohort 5
Single dose of 1 mg LY3463251 administered SC on Day 1.
6
3 mg LY3463251 Part A Cohort 6
Single dose of 3 mg LY3463251 administered SC on Day 1.
6
10 mg LY3463251 Part A Cohort 7
Single dose of 10 mg LY3463251 administered SC on Day 1.
6
24 mg LY3463251 Part A Cohort 8
Single dose of 24 mg LY3463251 administered SC on Day 1.
6
Placebo Multiple Dose
Placebo administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
13
1 mg LY3463251 Part B Cohort 1
1 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
10
3 mg LY3465231 Part B Cohort 2
3 mg LY3463251 administered SC, QW on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
10
3/6/9 mg LY3463251 Part B Cohort 3
3 mg LY3463251 administered SC, QW on Days 1 and 8. 6 mg LY3463251 administered SC, QW on Days 15 and 22. 9 mg LY3463251 administered SC, QW on Days 29. 36, 43, 50, 57, 64, 71, and 78.
18
3/9/15/24 mg LY3463251 Part B Cohort 4
3 mg LY3463251 administered SC, QW on Days 1 and 8. 9 mg LY3463251 administered SC, QW on Days 15 and 22. 15 mg LY3463251 administered SC, QW on Days 29 and 36. 24 mg LY3463251 administered SC, QW on Days 43, 50, 57, 64, 71, and 78.
3
Total118

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013
Overall StudyAdverse Event00000000000020
Overall StudyLost to Follow-up00000000000001
Overall StudyPhysician Decision00000000041490
Overall StudyStudy Termination00000000010002
Overall StudyWithdrawal by Subject00000000001000

Baseline characteristics

CharacteristicPlacebo Single Dose0.01 Milligram (mg) LY3463251 Part A Cohort 10.03 mg LY3463251 Part A Cohort 20.1 mg LY3463251 Part A Cohort 30.3 mg LY3463251 Part A Cohort 41 mg LY3463251 Part A Cohort 53 mg LY3463251 Part A Cohort 610 mg LY3463251 Part A Cohort 724 mg LY3463251 Part A Cohort 8Placebo Multiple Dose1 mg LY3463251 Part B Cohort 13 mg LY3465231 Part B Cohort 23/6/9 mg LY3463251 Part B Cohort 33/9/15/24 mg LY3463251 Part B Cohort 4Total
Age, Continuous48.3 years
STANDARD_DEVIATION 13.9
47.0 years
STANDARD_DEVIATION 18.1
52.2 years
STANDARD_DEVIATION 10.3
49.0 years
STANDARD_DEVIATION 15.8
41.0 years
STANDARD_DEVIATION 17.4
35.8 years
STANDARD_DEVIATION 12.2
45.2 years
STANDARD_DEVIATION 11.5
53.8 years
STANDARD_DEVIATION 2.8
43.7 years
STANDARD_DEVIATION 15.3
46.9 years
STANDARD_DEVIATION 11.6
48.2 years
STANDARD_DEVIATION 11.9
45.5 years
STANDARD_DEVIATION 9.7
47.9 years
STANDARD_DEVIATION 12.4
37.0 years
STANDARD_DEVIATION 10.8
46.48 years
STANDARD_DEVIATION 12.72
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants5 Participants3 Participants4 Participants5 Participants3 Participants2 Participants3 Participants5 Participants8 Participants8 Participants6 Participants9 Participants3 Participants76 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants1 Participants3 Participants2 Participants1 Participants3 Participants4 Participants3 Participants1 Participants5 Participants2 Participants4 Participants9 Participants0 Participants42 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
5 Participants1 Participants2 Participants1 Participants4 Participants1 Participants1 Participants0 Participants1 Participants3 Participants2 Participants3 Participants6 Participants2 Participants32 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
11 Participants5 Participants4 Participants5 Participants2 Participants4 Participants5 Participants6 Participants5 Participants10 Participants8 Participants7 Participants12 Participants1 Participants85 Participants
Region of Enrollment
United States
16 Participants6 Participants6 Participants6 Participants6 Participants6 Participants6 Participants6 Participants6 Participants13 Participants10 Participants10 Participants18 Participants3 Participants118 Participants
Sex: Female, Male
Female
5 Participants3 Participants3 Participants3 Participants1 Participants0 Participants3 Participants5 Participants1 Participants6 Participants2 Participants4 Participants7 Participants0 Participants43 Participants
Sex: Female, Male
Male
11 Participants3 Participants3 Participants3 Participants5 Participants6 Participants3 Participants1 Participants5 Participants7 Participants8 Participants6 Participants11 Participants3 Participants75 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 60 / 60 / 60 / 60 / 60 / 60 / 60 / 60 / 130 / 100 / 100 / 180 / 3
other
Total, other adverse events
1 / 160 / 60 / 62 / 62 / 62 / 61 / 66 / 66 / 65 / 135 / 105 / 1013 / 183 / 3
serious
Total, serious adverse events
0 / 160 / 60 / 60 / 60 / 60 / 60 / 60 / 60 / 60 / 130 / 100 / 100 / 180 / 3

Outcome results

Primary

Number of Participants With One or More Adverse Event(s) (AEs), All Causalities

A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time frame: Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123)

Population: All enrolled participants, whether or not they completed all protocol requirements.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Placebo Single DoseNumber of Participants With One or More Adverse Event(s) (AEs), All Causalities1 Participants
0.01 Milligram (mg) LY3463251 Part A Cohort 1Number of Participants With One or More Adverse Event(s) (AEs), All Causalities0 Participants
0.03 mg LY3463251 Part A Cohort 2Number of Participants With One or More Adverse Event(s) (AEs), All Causalities0 Participants
0.1 mg LY3463251 Part A Cohort 3Number of Participants With One or More Adverse Event(s) (AEs), All Causalities2 Participants
0.3 mg LY3463251 Part A Cohort 4Number of Participants With One or More Adverse Event(s) (AEs), All Causalities2 Participants
1 mg LY3463251 Part A Cohort 5Number of Participants With One or More Adverse Event(s) (AEs), All Causalities2 Participants
3 mg LY3463251 Part A Cohort 6Number of Participants With One or More Adverse Event(s) (AEs), All Causalities1 Participants
10 mg LY3463251 Part A Cohort 7Number of Participants With One or More Adverse Event(s) (AEs), All Causalities6 Participants
24 mg LY3463251 Part A Cohort 8Number of Participants With One or More Adverse Event(s) (AEs), All Causalities6 Participants
Placebo Multiple DoseNumber of Participants With One or More Adverse Event(s) (AEs), All Causalities5 Participants
1 mg LY3463251 Part B Cohort 1Number of Participants With One or More Adverse Event(s) (AEs), All Causalities5 Participants
3 mg LY3465231 Part B Cohort 2Number of Participants With One or More Adverse Event(s) (AEs), All Causalities5 Participants
3/6/9 mg LY3463251 Part B Cohort 3Number of Participants With One or More Adverse Event(s) (AEs), All Causalities13 Participants
3/9/15/24 mg LY3463251 Part B Cohort 4Number of Participants With One or More Adverse Event(s) (AEs), All Causalities3 Participants
Secondary

Change From Baseline in Body Weight at Day 85 Part B

Change from Baseline in Body Weight

Time frame: Baseline, Day 85 (Part B)

Population: All participants who received at least one dose of LY3463251 and had evaluable PD data in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 85).

ArmMeasureValue (MEAN)Dispersion
Placebo Single DoseChange From Baseline in Body Weight at Day 85 Part B2.11 kilograms (kg)Standard Deviation 1.8
0.01 Milligram (mg) LY3463251 Part A Cohort 1Change From Baseline in Body Weight at Day 85 Part B0.77 kilograms (kg)Standard Deviation 2.66
0.1 mg LY3463251 Part A Cohort 3Change From Baseline in Body Weight at Day 85 Part B-0.28 kilograms (kg)Standard Deviation 2.09
Secondary

Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part B

AUC of glucose was analyzed using a model with treatment + Day + Treatment\*Day + Subject + Random Error where Subject is fitted as a random effect and a repeated statement used with an Unstructured covariance structure.

Time frame: PD: Day -2; Predose: Day 30 and Day 85 (Part B)

Population: All participants who received at least one dose of LY3463251 and had evaluable PD data in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 85).

ArmMeasureGroupValue (MEAN)Dispersion
Placebo Single DosePharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay -214.47 millimole*hour per Liter (mmol*h/L)Standard Deviation 1.99
Placebo Single DosePharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay 3016.30 millimole*hour per Liter (mmol*h/L)Standard Deviation 2.39
Placebo Single DosePharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay 8515.64 millimole*hour per Liter (mmol*h/L)Standard Deviation 2.16
0.01 Milligram (mg) LY3463251 Part A Cohort 1Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay 3017.37 millimole*hour per Liter (mmol*h/L)Standard Deviation 2.47
0.01 Milligram (mg) LY3463251 Part A Cohort 1Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay -216.54 millimole*hour per Liter (mmol*h/L)Standard Deviation 1.95
0.01 Milligram (mg) LY3463251 Part A Cohort 1Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay 8515.35 millimole*hour per Liter (mmol*h/L)Standard Deviation 1.66
0.03 mg LY3463251 Part A Cohort 2Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay 3017.12 millimole*hour per Liter (mmol*h/L)Standard Deviation 3.31
0.03 mg LY3463251 Part A Cohort 2Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay -214.04 millimole*hour per Liter (mmol*h/L)Standard Deviation 3.01
0.1 mg LY3463251 Part A Cohort 3Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay 8514.51 millimole*hour per Liter (mmol*h/L)Standard Deviation 2.92
0.1 mg LY3463251 Part A Cohort 3Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay 3017.33 millimole*hour per Liter (mmol*h/L)Standard Deviation 2.78
0.1 mg LY3463251 Part A Cohort 3Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay -215.52 millimole*hour per Liter (mmol*h/L)Standard Deviation 2.7
0.3 mg LY3463251 Part A Cohort 4Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay 30NA millimole*hour per Liter (mmol*h/L)—
0.3 mg LY3463251 Part A Cohort 4Pharmacodynamics (PD): AUC (0-2hours) of Glucose Part BDay -212.39 millimole*hour per Liter (mmol*h/L)Standard Deviation 1.72
Secondary

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A

PK: Cmax of LY3463251

Time frame: Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose

Population: All participants who received at least one dose of LY3463251 and had evaluable PK data in Part A.

ArmMeasureValue (GEOMETRIC_LEAST_SQUARES_MEAN)Dispersion
Placebo Single DosePharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part ANA nanogram per milliliter (ng/mL)—
0.01 Milligram (mg) LY3463251 Part A Cohort 1Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part ANA nanogram per milliliter (ng/mL)—
0.03 mg LY3463251 Part A Cohort 2Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A9.91 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 17
0.1 mg LY3463251 Part A Cohort 3Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A16.5 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 56
0.3 mg LY3463251 Part A Cohort 4Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A55.0 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 26
1 mg LY3463251 Part A Cohort 5Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A229 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 31
3 mg LY3463251 Part A Cohort 6Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A583 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 35
10 mg LY3463251 Part A Cohort 7Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 Part A1810 nanogram per milliliter (ng/mL)Geometric Coefficient of Variation 19
Secondary

PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part B

PK: AUC(0-tau) of LY3463251 during one dosing interval on Day 1 and Day 78.

Time frame: Day 1: Predose, 6, 12, 24, 48, 72, 120, and 168 hours (hr) postdose: Day 78: Predose, 24, 48, 168, 336, 696, 1080 hr postdose

Population: All participants who received at least one dose of LY3463251 and had evaluable PK data in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 78).

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Placebo Single DosePK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part BDay 15650 ng*h/mLGeometric Coefficient of Variation 34
Placebo Single DosePK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part BDay 7818000 ng*h/mLGeometric Coefficient of Variation 33
0.01 Milligram (mg) LY3463251 Part A Cohort 1PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part BDay 118900 ng*h/mLGeometric Coefficient of Variation 18
0.03 mg LY3463251 Part A Cohort 2PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part BDay 120400 ng*h/mLGeometric Coefficient of Variation 41
0.03 mg LY3463251 Part A Cohort 2PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part BDay 78167000 ng*h/mLGeometric Coefficient of Variation 14
0.1 mg LY3463251 Part A Cohort 3PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUC[0-tau)] for LY3463251 Part BDay 1NA ng*h/mL—
Secondary

PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A

PK: AUC versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LY3463251.

Time frame: Day 1: Predose, 6, 12, 24, 48, 72, 96, 120, 168, 264, 360, 528, 696, and 1008 hr postdose

Population: All participants who received at least one dose of LY3463251 and had evaluable PK data in Part A.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
Placebo Single DosePK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part ANA nanogram * hour per milliliter (ng*h/mL)—
0.01 Milligram (mg) LY3463251 Part A Cohort 1PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part ANA nanogram * hour per milliliter (ng*h/mL)—
0.03 mg LY3463251 Part A Cohort 2PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A1470 nanogram * hour per milliliter (ng*h/mL)Geometric Coefficient of Variation 48
0.1 mg LY3463251 Part A Cohort 3PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A3010 nanogram * hour per milliliter (ng*h/mL)Geometric Coefficient of Variation 50
0.3 mg LY3463251 Part A Cohort 4PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A15700 nanogram * hour per milliliter (ng*h/mL)Geometric Coefficient of Variation 15
1 mg LY3463251 Part A Cohort 5PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A75100 nanogram * hour per milliliter (ng*h/mL)Geometric Coefficient of Variation 15
3 mg LY3463251 Part A Cohort 6PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A245000 nanogram * hour per milliliter (ng*h/mL)Geometric Coefficient of Variation 17
10 mg LY3463251 Part A Cohort 7PK: Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tlast]) of LY3463251 Part A527000 nanogram * hour per milliliter (ng*h/mL)Geometric Coefficient of Variation 21
Secondary

PK: Maximum Observed Concentration of LY3463251 Part B

PK: Cmax of LY3463251

Time frame: Day 1: Predose, 6, 12, 24, 48, 72, and 120 hours (hr) postdose; Day 8: Predose; Day 15: Predose; Day 28: Predose; Day 57: Predose; Day 78: Predose, and Day 79: 24 hr postdose

Population: All participants who received at least one dose of LY3463251 and had evaluable PK in Part B. Data were not collected for the treatment arms (3 mg and 3/9/15/24 mg) because the study was early terminated prior to participants' assessment at the pre-specified time point (Day 78).

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
Placebo Single DosePK: Maximum Observed Concentration of LY3463251 Part BDay 78124 ng/mLGeometric Coefficient of Variation 29
Placebo Single DosePK: Maximum Observed Concentration of LY3463251 Part BDay 141.7 ng/mLGeometric Coefficient of Variation 30
0.01 Milligram (mg) LY3463251 Part A Cohort 1PK: Maximum Observed Concentration of LY3463251 Part BDay 1129 ng/mLGeometric Coefficient of Variation 19
0.03 mg LY3463251 Part A Cohort 2PK: Maximum Observed Concentration of LY3463251 Part BDay 1150 ng/mLGeometric Coefficient of Variation 38
0.03 mg LY3463251 Part A Cohort 2PK: Maximum Observed Concentration of LY3463251 Part BDay 781190 ng/mLGeometric Coefficient of Variation 15
0.1 mg LY3463251 Part A Cohort 3PK: Maximum Observed Concentration of LY3463251 Part BDay 1109 ng/mLGeometric Coefficient of Variation 28

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026