Trial Outcomes & Findings for A Study of LY3053102 in Healthy Participants (NCT NCT01736241)

NCT ID: NCT01736241

Last Updated: 2018-07-19

Results Overview

A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

Baseline through Day 31

Results posted on

2018-07-19

Participant Flow

Participant milestones

Participant milestones
Measure
2 mg LY3053102
LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
7 mg LY3053102
LY3053102: A single dose of 7 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
20 mg LY3053102
LY3053102: A single dose of 20 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
50 mg LY3053102
LY3053102: A single dose of 50 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
150 mg LY3053102
LY3053102: A single dose of 150 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
405 mg LY3053102
LY3053102: A single dose of 405 mg, administered subcutaneously.
Placebo
Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort.
Overall Study
STARTED
6
6
6
5
6
6
6
Overall Study
Received at Least One Dose of Study Drug
6
6
6
5
6
6
6
Overall Study
COMPLETED
6
6
6
5
6
6
6
Overall Study
NOT COMPLETED
0
0
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of LY3053102 in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
2 mg LY3053102
n=6 Participants
LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
7 mg LY3053102
n=6 Participants
LY3053102: A single dose of 7 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
20 mg LY3053102
n=6 Participants
LY3053102: A single dose of 20 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
50 mg LY3053102
n=5 Participants
LY3053102: A single dose of 50 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
150 mg LY3053102
n=6 Participants
LY3053102: A single dose of 150 mg, administered subcutaneously. The dose was escalated for a new cohort of randomized participants based on the safety results over at least a 7-day evaluation period postdose.
405 mg LY3053102
n=6 Participants
LY3053102: A single dose of 405 mg, administered subcutaneously.
Placebo
n=6 Participants
Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 newly randomized participant in each LY3053102-dose level cohort.
Total
n=41 Participants
Total of all reporting groups
Age, Continuous
35.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
33.2 years
STANDARD_DEVIATION 4.3 • n=7 Participants
39.7 years
STANDARD_DEVIATION 11.1 • n=5 Participants
36.2 years
STANDARD_DEVIATION 14.7 • n=4 Participants
34.3 years
STANDARD_DEVIATION 10.7 • n=21 Participants
31.0 years
STANDARD_DEVIATION 8.9 • n=10 Participants
34.5 years
STANDARD_DEVIATION 7.4 • n=115 Participants
34.8 years
STANDARD_DEVIATION 9.4 • n=24 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
2 Participants
n=24 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
6 Participants
n=7 Participants
5 Participants
n=5 Participants
5 Participants
n=4 Participants
6 Participants
n=21 Participants
6 Participants
n=10 Participants
6 Participants
n=115 Participants
39 Participants
n=24 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
5 Participants
n=4 Participants
6 Participants
n=21 Participants
6 Participants
n=10 Participants
6 Participants
n=115 Participants
41 Participants
n=24 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
Asian
6 Participants
n=5 Participants
6 Participants
n=7 Participants
5 Participants
n=5 Participants
5 Participants
n=4 Participants
5 Participants
n=21 Participants
6 Participants
n=10 Participants
5 Participants
n=115 Participants
38 Participants
n=24 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
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=10 Participants
1 Participants
n=115 Participants
3 Participants
n=24 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=24 Participants
Region of Enrollment
Singapore
6 participants
n=5 Participants
6 participants
n=7 Participants
6 participants
n=5 Participants
5 participants
n=4 Participants
6 participants
n=21 Participants
6 participants
n=10 Participants
6 participants
n=115 Participants
41 participants
n=24 Participants

PRIMARY outcome

Timeframe: Baseline through Day 31

Population: Participants who received at least one dose of LY3053102 or placebo.

A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Outcome measures

Outcome measures
Measure
2 mg LY3053102
n=6 Participants
LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously.
7 mg LY3053102
n=6 Participants
LY3053102: A single dose of 7 mg, administered subcutaneously.
20 mg LY3053102
n=6 Participants
LY3053102: A single dose of 20 mg, administered subcutaneously.
50 mg LY3053102
n=5 Participants
LY3053102: A single dose of 50 mg, administered subcutaneously.
150 mg LY3053102
n=6 Participants
LY3053102: A single dose of 150 mg, administered subcutaneously.
405 mg LY3053102
n=6 Participants
LY3053102: A single dose of 405 mg, administered subcutaneously.
Placebo
n=6 Participants
Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort.
Number of Participants With One or More Adverse Events (AEs) or Any Serious AEs
5 participants
6 participants
4 participants
4 participants
6 participants
5 participants
6 participants

SECONDARY outcome

Timeframe: Time 0 to 168 hours after study drug administration on Day 1

Population: Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data.

AUC curve from time 0 to 168 hours postdose of LY3053102.

Outcome measures

Outcome measures
Measure
2 mg LY3053102
n=6 Participants
LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously.
7 mg LY3053102
n=6 Participants
LY3053102: A single dose of 7 mg, administered subcutaneously.
20 mg LY3053102
n=6 Participants
LY3053102: A single dose of 20 mg, administered subcutaneously.
50 mg LY3053102
n=5 Participants
LY3053102: A single dose of 50 mg, administered subcutaneously.
150 mg LY3053102
n=6 Participants
LY3053102: A single dose of 150 mg, administered subcutaneously.
405 mg LY3053102
n=6 Participants
LY3053102: A single dose of 405 mg, administered subcutaneously.
Placebo
Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3053102
7.24 microgram*hour/milliliter
Geometric Coefficient of Variation 29.6
16.1 microgram*hour/milliliter
Geometric Coefficient of Variation 50.3
94.0 microgram*hour/milliliter
Geometric Coefficient of Variation 45.5
192 microgram*hour/milliliter
Geometric Coefficient of Variation 38.0
481 microgram*hour/milliliter
Geometric Coefficient of Variation 74.0
1810 microgram*hour/milliliter
Geometric Coefficient of Variation 49.1

SECONDARY outcome

Timeframe: Time 0 to 168 hours after study drug administration on Day 1

Population: Participants who received at least one dose of LY3053102 and with evaluable LY3053102 concentration data.

Cmax of LY3053102 from time 0 to 168 hours after study drug administration on Day 1.

Outcome measures

Outcome measures
Measure
2 mg LY3053102
n=6 Participants
LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously.
7 mg LY3053102
n=6 Participants
LY3053102: A single dose of 7 mg, administered subcutaneously.
20 mg LY3053102
n=6 Participants
LY3053102: A single dose of 20 mg, administered subcutaneously.
50 mg LY3053102
n=5 Participants
LY3053102: A single dose of 50 mg, administered subcutaneously.
150 mg LY3053102
n=6 Participants
LY3053102: A single dose of 150 mg, administered subcutaneously.
405 mg LY3053102
n=6 Participants
LY3053102: A single dose of 405 mg, administered subcutaneously.
Placebo
Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort.
PK: Observed Maximum Drug Concentration (Cmax) of LY3053102
0.0693 microgram/milliliter
Geometric Coefficient of Variation 30.2
0.140 microgram/milliliter
Geometric Coefficient of Variation 52.0
0.784 microgram/milliliter
Geometric Coefficient of Variation 46.8
1.68 microgram/milliliter
Geometric Coefficient of Variation 44.7
4.49 microgram/milliliter
Geometric Coefficient of Variation 67.6
16.2 microgram/milliliter
Geometric Coefficient of Variation 49.0

SECONDARY outcome

Timeframe: Baseline, up to Day 31

Population: Participants who received at least one dose of LY3053102 or placebo and with evaluable anti-drug (LY3053102) ADA data.

LY3053102 anti-drug antibodies (ADA) were assessed at baseline, 15 and 29 days. The number of participants with an initial postbaseline positive titer (defined as a \>=2-fold increase in the ADA titer from baseline) anti-drug (LY3053102) ADA at each time point were summarized.

Outcome measures

Outcome measures
Measure
2 mg LY3053102
n=6 Participants
LY3053102: A single dose of 2 milligrams (mg), administered subcutaneously.
7 mg LY3053102
n=6 Participants
LY3053102: A single dose of 7 mg, administered subcutaneously.
20 mg LY3053102
n=6 Participants
LY3053102: A single dose of 20 mg, administered subcutaneously.
50 mg LY3053102
n=5 Participants
LY3053102: A single dose of 50 mg, administered subcutaneously.
150 mg LY3053102
n=6 Participants
LY3053102: A single dose of 150 mg, administered subcutaneously.
405 mg LY3053102
n=6 Participants
LY3053102: A single dose of 405 mg, administered subcutaneously.
Placebo
n=6 Participants
Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort.
Number of Participants Who Developed Anti-LY3053102 Antibodies
Day 29
0 participants
1 participants
0 participants
0 participants
0 participants
0 participants
0 participants
Number of Participants Who Developed Anti-LY3053102 Antibodies
Day 15
0 participants
1 participants
0 participants
0 participants
0 participants
0 participants
0 participants

Adverse Events

2 mg LY3053102

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

7 mg LY3053102

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

20 mg LY3053102

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

50 mg LY3053102

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

150 mg LY3053102

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

405 mg LY3053102

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
2 mg LY3053102
n=6 participants at risk
LY3053102: A single dose of 2 mg, administered subcutaneously.
7 mg LY3053102
n=6 participants at risk
LY3053102: A single dose of 7 mg, administered subcutaneously.
20 mg LY3053102
n=6 participants at risk
LY3053102: A single dose of 20 mg, administered subcutaneously.
50 mg LY3053102
n=5 participants at risk
LY3053102: A single dose of 50 mg, administered subcutaneously.
150 mg LY3053102
n=6 participants at risk
LY3053102: A single dose of 150 mg, administered subcutaneously.
405 mg LY3053102
n=6 participants at risk
LY3053102: A single dose of 405 mg, administered subcutaneously.
Placebo
n=6 participants at risk
Placebo: A single dose of LY3053102-matching placebo, administered subcutaneously to 1 participant in each LY3053102-dose level cohort.
Gastrointestinal disorders
Abdominal distension
0.00%
0/6
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
Gastrointestinal disorders
Diarrhoea
16.7%
1/6 • Number of events 1
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
50.0%
3/6 • Number of events 3
16.7%
1/6 • Number of events 1
Gastrointestinal disorders
Dry mouth
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
Gastrointestinal disorders
Mouth ulceration
0.00%
0/6
0.00%
0/6
0.00%
0/6
20.0%
1/5 • Number of events 1
0.00%
0/6
0.00%
0/6
0.00%
0/6
Gastrointestinal disorders
Nausea
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
50.0%
3/6 • Number of events 3
0.00%
0/6
Gastrointestinal disorders
Vomiting
16.7%
1/6 • Number of events 1
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
General disorders
Feeling cold
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
0.00%
0/6
16.7%
1/6 • Number of events 1
General disorders
Injection site erythema
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
33.3%
2/6 • Number of events 2
0.00%
0/6
0.00%
0/6
General disorders
Injection site haematoma
16.7%
1/6 • Number of events 1
16.7%
1/6 • Number of events 1
0.00%
0/6
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
General disorders
Pyrexia
0.00%
0/6
16.7%
1/6 • Number of events 1
16.7%
1/6 • Number of events 1
0.00%
0/5
0.00%
0/6
0.00%
0/6
33.3%
2/6 • Number of events 2
General disorders
Temperature intolerance
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
General disorders
Thirst
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
Injury, poisoning and procedural complications
Arthropod bite
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
0.00%
0/6
16.7%
1/6 • Number of events 1
Injury, poisoning and procedural complications
Excoriation
16.7%
1/6 • Number of events 1
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
0.00%
0/6
0.00%
0/6
Injury, poisoning and procedural complications
Laceration
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
16.7%
1/6 • Number of events 1
0.00%
0/6
0.00%
0/6
Injury, poisoning and procedural complications
Procedural site reaction
50.0%
3/6 • Number of events 4
0.00%
0/6
16.7%
1/6 • Number of events 1
20.0%
1/5 • Number of events 1
16.7%
1/6 • Number of events 3
33.3%
2/6 • Number of events 3
83.3%
5/6 • Number of events 6
Injury, poisoning and procedural complications
Scratch
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
16.7%
1/6 • Number of events 1
0.00%
0/6
0.00%
0/6
Metabolism and nutrition disorders
Increased appetite
33.3%
2/6 • Number of events 2
83.3%
5/6 • Number of events 5
66.7%
4/6 • Number of events 4
40.0%
2/5 • Number of events 2
83.3%
5/6 • Number of events 5
83.3%
5/6 • Number of events 5
16.7%
1/6 • Number of events 1
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
0.00%
0/5
0.00%
0/6
0.00%
0/6
0.00%
0/6
Nervous system disorders
Dysgeusia
0.00%
0/6
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
Nervous system disorders
Headache
16.7%
1/6 • Number of events 1
50.0%
3/6 • Number of events 3
16.7%
1/6 • Number of events 1
0.00%
0/5
0.00%
0/6
0.00%
0/6
16.7%
1/6 • Number of events 1
Nervous system disorders
Tremor
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
Psychiatric disorders
Tobacco abuse
0.00%
0/6
0.00%
0/6
0.00%
0/6
20.0%
1/5 • Number of events 1
0.00%
0/6
0.00%
0/6
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/6
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/5
33.3%
2/6 • Number of events 2
16.7%
1/6 • Number of events 1
16.7%
1/6 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/6
16.7%
1/6 • Number of events 1
16.7%
1/6 • Number of events 1
0.00%
0/5
16.7%
1/6 • Number of events 1
16.7%
1/6 • Number of events 1
0.00%
0/6
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
16.7%
1/6 • Number of events 1
0.00%
0/6
0.00%
0/6
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6
Skin and subcutaneous tissue disorders
Rash erythematous
0.00%
0/6
0.00%
0/6
0.00%
0/6
0.00%
0/5
0.00%
0/6
16.7%
1/6 • Number of events 1
0.00%
0/6

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60