Trial Outcomes & Findings for A Study of Donanemab (LY3002813) in Healthy Chinese Participants (NCT NCT05533411)

Last Updated: 2024-10-04

Results Overview

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

Baseline up to Day 85

Results posted on

2024-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Single placebo dose administered intravenously (IV) on Day 1.	350 Milligram (mg) Donanemab Single 350 mg Donanemab dose administered IV on Day 1.	700 mg Donanemab Single 700 mg Donanemab dose administered IV on Day 1.	1400 mg Donanemab Single 1400 mg Donanemab dose administered IV on Day 1.
Overall Study STARTED	6	10	10	10
Overall Study Received At Least 1 Dose of Study Drug	6	10	10	10
Overall Study COMPLETED	6	10	10	10
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Donanemab (LY3002813) in Healthy Chinese Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=6 Participants Single placebo dose administered IV on Day 1.	350 mg Donanemab n=10 Participants Single 350 mg Donanemab dose administered IV on Day 1.	700 mg Donanemab n=10 Participants Single 700 mg Donanemab dose administered IV on Day 1.	1400 mg Donanemab n=10 Participants Single 1400 mg Donanemab dose administered IV on Day 1.	Total n=36 Participants Total of all reporting groups
Age, Continuous	27.0 years STANDARD_DEVIATION 7.0 • n=99 Participants	28.1 years STANDARD_DEVIATION 6.2 • n=107 Participants	32.8 years STANDARD_DEVIATION 4.5 • n=206 Participants	27.9 years STANDARD_DEVIATION 5.8 • n=157 Participants	29.2 years STANDARD_DEVIATION 6.0 • n=390 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Sex: Female, Male Male	6 Participants n=99 Participants	10 Participants n=107 Participants	10 Participants n=206 Participants	10 Participants n=157 Participants	36 Participants n=390 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Asian	6 Participants n=99 Participants	10 Participants n=107 Participants	10 Participants n=206 Participants	10 Participants n=157 Participants	36 Participants n=390 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) White	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants	0 Participants n=390 Participants
Region of Enrollment China	6 Participants n=99 Participants	10 Participants n=107 Participants	10 Participants n=206 Participants	10 Participants n=157 Participants	36 Participants n=390 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 85

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Single placebo dose administered IV on Day 1.	350 mg Donanemab n=10 Participants Single 350 mg Donanemab dose administered IV on Day 1.	700 mg Donanemab n=10 Participants Single 700 mg Donanemab dose administered IV on Day 1.	1400 mg Donanemab n=10 Participants Single 1400 mg Donanemab dose administered IV on Day 1.
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Treatment-emergent Adverse Events	1 participants	2 participants	0 participants	0 participants
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Serious Adverse Events	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose

Population: All enrolled participants who received at least 1 full dose of donanemab and had baseline, and at least 1 postbaseline evaluable PK sample.

PK: Cmax of Donanemab

Outcome measures

Outcome measures
Measure	Placebo n=10 Participants Single placebo dose administered IV on Day 1.	350 mg Donanemab n=10 Participants Single 350 mg Donanemab dose administered IV on Day 1.	700 mg Donanemab n=10 Participants Single 700 mg Donanemab dose administered IV on Day 1.	1400 mg Donanemab Single 1400 mg Donanemab dose administered IV on Day 1.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Donanemab	119 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 13	236 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 9	539 microgram per milliliter (μg/mL) Geometric Coefficient of Variation 30	—

SECONDARY outcome

Timeframe: Predose, Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57 and 85 postdose

Population: All enrolled participants who received at least 1 full dose of donanemab and had baseline, and at least 1 postbaseline evaluable PK sample.

PK: AUC\[0-∞\] of Donanemab

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Single placebo dose administered IV on Day 1.	350 mg Donanemab n=10 Participants Single 350 mg Donanemab dose administered IV on Day 1.	700 mg Donanemab n=10 Participants Single 700 mg Donanemab dose administered IV on Day 1.	1400 mg Donanemab Single 1400 mg Donanemab dose administered IV on Day 1.
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Donanemab	9050 microgram * hour/milliliter (μg.h/mL) Geometric Coefficient of Variation 23	22600 microgram * hour/milliliter (μg.h/mL) Geometric Coefficient of Variation 17	53100 microgram * hour/milliliter (μg.h/mL) Geometric Coefficient of Variation 27	—

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

350 Milligrams (mg) Donanemab

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

700 mg Donanemab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

1400 mg Donanemab

Serious events: 0 serious events

Other events: 5 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: 8005955979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Placebo n=6 participants at risk Single placebo dose administered intravenously (IV) on Day 1.	350 Milligrams (mg) Donanemab n=10 participants at risk Single 350 mg Donanemab dose administered IV on Day 1.	700 mg Donanemab n=10 participants at risk Single 700 mg Donanemab dose administered IV on Day 1.	1400 mg Donanemab n=10 participants at risk Single 1400 mg Donanemab dose administered IV on Day 1.
Immune system disorders Allergy to arthropod bite	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Infections and infestations Asymptomatic COVID-19	16.7% 1/6 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	30.0% 3/10 • Number of events 3 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Infections and infestations COVID-19	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	20.0% 2/10 • Number of events 2 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Infections and infestations Otitis media	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Investigations Alanine aminotransferase increased	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Investigations Blood creatine phosphokinase increased	16.7% 1/6 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 2 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Investigations Blood urea increased	16.7% 1/6 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Investigations Blood uric acid increased	50.0% 3/6 • Number of events 3 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Investigations Lymphocyte count decreased	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Investigations Neutrophil count increased	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Investigations White blood cell count increased	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/6 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	10.0% 1/10 • Number of events 1 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.	0.00% 0/10 • Baseline up to 85 days All participants randomly assigned to study intervention and who take at least 1 dose of study intervention.