Trial Outcomes & Findings for A Study of LY3025876 in Healthy Volunteers (NCT NCT01528124)
NCT ID: NCT01528124
Last Updated: 2018-07-16
Results Overview
Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
41 participants
Primary outcome timeframe
Baseline up to 28 days post-dose
Results posted on
2018-07-16
Participant Flow
Participant milestones
| Measure |
Placebo
Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
|
0.15 mg LY3025876
0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
|
0.5 mg LY3025876
0.5 mg LY3025876 administered as subcutaneous injection
|
1.5 mg LY3025876
1.5 mg LY3025876 administered as subcutaneous injection
|
5 mg LY3025876
5 mg LY3025876 administered as subcutaneous injection
|
15 mg LY3025876
15 mg LY3025876 administered as subcutaneous injection
|
30 mg LY3025876
30 mg LY3025876 administered as subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
5
|
6
|
6
|
|
Overall Study
Received Study Drug
|
6
|
6
|
6
|
6
|
5
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
5
|
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 LY3025876 in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
|
0.15 mg LY3025876
n=6 Participants
0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
|
0.5 mg LY3025876
n=6 Participants
0.5 mg LY3025876 administered as subcutaneous injection
|
1.5 mg LY3025876
n=6 Participants
1.5 mg LY3025876 administered as subcutaneous injection
|
5 mg LY3025876
n=5 Participants
5 mg LY3025876 administered as subcutaneous injection
|
15 mg LY3025876
n=6 Participants
15 mg LY3025876 administered as subcutaneous injection
|
30 mg LY3025876
n=6 Participants
30 mg LY3025876 administered as subcutaneous injection
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
33.7 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 3.8 • n=4 Participants
|
29.4 years
STANDARD_DEVIATION 7.4 • n=21 Participants
|
27.8 years
STANDARD_DEVIATION 4.5 • n=8 Participants
|
31.3 years
STANDARD_DEVIATION 7.2 • n=8 Participants
|
32.1 years
STANDARD_DEVIATION 7.2 • n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
40 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=8 Participants
|
0 Participants
n=8 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
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 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=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
41 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=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
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=8 Participants
|
0 Participants
n=8 Participants
|
0 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=8 Participants
|
0 Participants
n=8 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=8 Participants
|
0 Participants
n=8 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
|
6 participants
n=4 Participants
|
5 participants
n=21 Participants
|
6 participants
n=8 Participants
|
6 participants
n=8 Participants
|
41 participants
n=24 Participants
|
|
Fasting Blood Glucose
|
4.68 millimole per liter (mmol/L)
STANDARD_DEVIATION 0.17 • n=5 Participants
|
4.45 millimole per liter (mmol/L)
STANDARD_DEVIATION 0.40 • n=7 Participants
|
4.43 millimole per liter (mmol/L)
STANDARD_DEVIATION 0.40 • n=5 Participants
|
4.97 millimole per liter (mmol/L)
STANDARD_DEVIATION 0.27 • n=4 Participants
|
4.68 millimole per liter (mmol/L)
STANDARD_DEVIATION 0.33 • n=21 Participants
|
4.20 millimole per liter (mmol/L)
STANDARD_DEVIATION 0.35 • n=8 Participants
|
4.57 millimole per liter (mmol/L)
STANDARD_DEVIATION 0.36 • n=8 Participants
|
4.57 millimole per liter (mmol/L)
STANDARD_DEVIATION 0.38 • n=24 Participants
|
|
Body Mass Index (BMI)
|
28.35 kilogram per meter squared (kg/m^2)
STANDARD_DEVIATION 2.31 • n=5 Participants
|
23.88 kilogram per meter squared (kg/m^2)
STANDARD_DEVIATION 4.91 • n=7 Participants
|
26.22 kilogram per meter squared (kg/m^2)
STANDARD_DEVIATION 5.65 • n=5 Participants
|
25.12 kilogram per meter squared (kg/m^2)
STANDARD_DEVIATION 1.99 • n=4 Participants
|
26.78 kilogram per meter squared (kg/m^2)
STANDARD_DEVIATION 6.62 • n=21 Participants
|
23.10 kilogram per meter squared (kg/m^2)
STANDARD_DEVIATION 3.48 • n=8 Participants
|
25.53 kilogram per meter squared (kg/m^2)
STANDARD_DEVIATION 2.91 • n=8 Participants
|
25.54 kilogram per meter squared (kg/m^2)
STANDARD_DEVIATION 4.23 • n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days post-dosePopulation: All enrolled participants who received at least 1 dose of study drug.
Possible drug-relatedness of an adverse event (AE) was in the opinion of the investigator. A summary of all serious and all other non-serious AEs, regardless of any possible causality, is located in the Reported Adverse Event Module.
Outcome measures
| Measure |
Placebo
n=6 Participants
Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
|
0.15 mg LY3025876
n=6 Participants
0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
|
0.5 mg LY3025876
n=6 Participants
0.5 mg LY3025876 administered as subcutaneous injection
|
1.5 mg LY3025876
n=6 Participants
1.5 mg LY3025876 administered as subcutaneous injection
|
5 mg LY3025876
n=5 Participants
5 mg LY3025876 administered as subcutaneous injection
|
15 mg LY3025876
n=6 Participants
15 mg LY3025876 administered as subcutaneous injection
|
30 mg LY3025876
n=6 Participants
30 mg LY3025876 administered as subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events
Serious AEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With 1 or More Drug-related Adverse Events or Any Serious Adverse Events
Other nonserious AEs
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dosePopulation: Pharmacokinetic (PK) Population: all participants who received at least 1 dose of study drug and had evaluable AUC(0-∞) PK data.
Area under the concentration-versus-time curve from time zero to infinity \[AUC(0-∞)\] of LY3025876.
Outcome measures
| Measure |
Placebo
n=6 Participants
Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
|
0.15 mg LY3025876
n=5 Participants
0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
|
0.5 mg LY3025876
n=6 Participants
0.5 mg LY3025876 administered as subcutaneous injection
|
1.5 mg LY3025876
n=5 Participants
1.5 mg LY3025876 administered as subcutaneous injection
|
5 mg LY3025876
n=6 Participants
5 mg LY3025876 administered as subcutaneous injection
|
15 mg LY3025876
n=6 Participants
15 mg LY3025876 administered as subcutaneous injection
|
30 mg LY3025876
30 mg LY3025876 administered as subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3025876
|
NA nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation NA
Not calculated, insufficient LY3025876 plasma concentrations were quantifiable for calculating AUC.
|
62.5 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 11.9
|
180 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 17.0
|
595 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 8.74
|
1920 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 9.99
|
3780 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 25.1
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dosePopulation: PK Population: all participants who received at least 1 dose of study drug and had evaluable Cmax PK data.
Outcome measures
| Measure |
Placebo
n=6 Participants
Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
|
0.15 mg LY3025876
n=6 Participants
0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
|
0.5 mg LY3025876
n=6 Participants
0.5 mg LY3025876 administered as subcutaneous injection
|
1.5 mg LY3025876
n=5 Participants
1.5 mg LY3025876 administered as subcutaneous injection
|
5 mg LY3025876
n=6 Participants
5 mg LY3025876 administered as subcutaneous injection
|
15 mg LY3025876
n=6 Participants
15 mg LY3025876 administered as subcutaneous injection
|
30 mg LY3025876
30 mg LY3025876 administered as subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3025876
|
1.88 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.2
|
7.25 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 53.1
|
16.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 18.2
|
55.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.5
|
187 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.9
|
347 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19.6
|
—
|
SECONDARY outcome
Timeframe: Day 28 post-dosePopulation: All randomized participants who received at least 1 dose of study drug.
Blood samples were collected from all randomized participants to test for the development of antibodies binding to LY3025876.
Outcome measures
| Measure |
Placebo
n=6 Participants
Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
|
0.15 mg LY3025876
n=6 Participants
0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
|
0.5 mg LY3025876
n=6 Participants
0.5 mg LY3025876 administered as subcutaneous injection
|
1.5 mg LY3025876
n=5 Participants
1.5 mg LY3025876 administered as subcutaneous injection
|
5 mg LY3025876
n=6 Participants
5 mg LY3025876 administered as subcutaneous injection
|
15 mg LY3025876
n=6 Participants
15 mg LY3025876 administered as subcutaneous injection
|
30 mg LY3025876
30 mg LY3025876 administered as subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Developing Anti-LY3025876 Antibodies
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.15 mg LY3025876
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.5 mg LY3025876
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1.5 mg LY3025876
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
5 mg LY3025876
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
15 mg LY3025876
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
30 mg LY3025876
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Normal sterile saline solution (0.9% sodium chloride) administered as subcutaneous injection
|
0.15 mg LY3025876
n=6 participants at risk
0.15 milligrams (mg) LY3025876 administered as subcutaneous injection
|
0.5 mg LY3025876
n=6 participants at risk
0.5 mg LY3025876 administered as subcutaneous injection
|
1.5 mg LY3025876
n=6 participants at risk
1.5 mg LY3025876 administered as subcutaneous injection
|
5 mg LY3025876
n=5 participants at risk
5 mg LY3025876 administered as subcutaneous injection
|
15 mg LY3025876
n=6 participants at risk
15 mg LY3025876 administered as subcutaneous injection
|
30 mg LY3025876
n=6 participants at risk
30 mg LY3025876 administered as subcutaneous injection
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • Number of events 1
|
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
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6
|
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
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/5
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
General disorders
Application site erythema
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Hunger
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Injection site pain
|
0.00%
0/6
|
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
|
|
General disorders
Injection site reaction
|
0.00%
0/6
|
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
|
|
General disorders
Pyrexia
|
0.00%
0/6
|
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
|
|
General disorders
Thirst
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/5
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6
|
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
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/5
|
50.0%
3/6 • Number of events 3
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
20.0%
1/5 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6
|
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
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6
|
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
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6
|
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
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6
|
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
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6
|
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
|
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