Trial Outcomes & Findings for A Study of LY3025876 in Participants With Diabetes (NCT NCT01870297)
NCT ID: NCT01870297
Last Updated: 2019-01-24
Results Overview
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Predose on Day 1 up to Day 56 in each Part
Results posted on
2019-01-24
Participant Flow
Dose escalation was planned for 20 milligrams (mg) of LY3025876 but dose escalation was only up to 15 mg LY3025876.
Participant milestones
| Measure |
Placebo Part A
Part A Placebo for LY3025876 administered as once daily (QD) subcutaneous (SQ) injections for up to 28 days.
|
0.5 mg LY3025876
Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
1.5 mg LY3025876
Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
5.0 mg LY3025876
Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
15 mg LY3025876
Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo + Liraglutide
Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
5.0 mg LY3025876 + Lirgalutide
Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
15
|
8
|
9
|
10
|
9
|
10
|
|
Overall Study
COMPLETED
|
11
|
8
|
7
|
9
|
7
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
7
|
1
|
0
|
3
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo Part A
Part A Placebo for LY3025876 administered as once daily (QD) subcutaneous (SQ) injections for up to 28 days.
|
0.5 mg LY3025876
Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
1.5 mg LY3025876
Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
5.0 mg LY3025876
Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
15 mg LY3025876
Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo + Liraglutide
Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
5.0 mg LY3025876 + Lirgalutide
Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
6
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY3025876 in Participants With Diabetes
Baseline characteristics by cohort
| Measure |
Placebo Part A
n=11 Participants
Part A Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
|
0.5 mg LY3025876
n=15 Participants
Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
1.5 mg LY3025876
n=8 Participants
Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
5.0 mg LY3025876
n=9 Participants
Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
15 mg LY3025876
n=10 Participants
Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo + Liraglutide
n=9 Participants
Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
5.0 mg LY3025876 + Liraglutide
n=10 Participants
Part B:5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Age Part A
|
53.4 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 7.6 • n=107 Participants
|
53.3 years
STANDARD_DEVIATION 7.2 • n=206 Participants
|
61.9 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
55.3 years
STANDARD_DEVIATION 6.8 • n=31 Participants
|
NA years
STANDARD_DEVIATION NA • n=30 Participants
|
NA years
STANDARD_DEVIATION NA • n=3 Participants
|
55.8 years
STANDARD_DEVIATION 7.8 • n=6 Participants
|
|
Age, Continuous
Age Part B
|
NA years
STANDARD_DEVIATION NA • n=99 Participants
|
NA years
STANDARD_DEVIATION NA • n=107 Participants
|
NA years
STANDARD_DEVIATION NA • n=206 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=31 Participants
|
53.2 years
STANDARD_DEVIATION 8.9 • n=30 Participants
|
54.4 years
STANDARD_DEVIATION 5.5 • n=3 Participants
|
53.8 years
STANDARD_DEVIATION 7.1 • n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
50 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
51 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
21 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 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=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=6 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=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
8 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
62 Participants
n=6 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=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 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=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
15 participants
n=107 Participants
|
8 participants
n=206 Participants
|
9 participants
n=7 Participants
|
10 participants
n=31 Participants
|
9 participants
n=30 Participants
|
10 participants
n=3 Participants
|
72 participants
n=6 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
HbA1c Part A
|
8.64 percent of HbA1c
STANDARD_DEVIATION 0.65 • n=99 Participants
|
8.39 percent of HbA1c
STANDARD_DEVIATION 0.93 • n=107 Participants
|
8.43 percent of HbA1c
STANDARD_DEVIATION 0.88 • n=206 Participants
|
8.94 percent of HbA1c
STANDARD_DEVIATION 1.19 • n=7 Participants
|
8.67 percent of HbA1c
STANDARD_DEVIATION 0.92 • n=31 Participants
|
NA percent of HbA1c
STANDARD_DEVIATION NA • n=30 Participants
|
NA percent of HbA1c
STANDARD_DEVIATION NA • n=3 Participants
|
8.59 percent of HbA1c
STANDARD_DEVIATION 0.91 • n=6 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
HbA1c Part B
|
NA percent of HbA1c
STANDARD_DEVIATION NA • n=99 Participants
|
NA percent of HbA1c
STANDARD_DEVIATION NA • n=107 Participants
|
NA percent of HbA1c
STANDARD_DEVIATION NA • n=206 Participants
|
NA percent of HbA1c
STANDARD_DEVIATION NA • n=7 Participants
|
NA percent of HbA1c
STANDARD_DEVIATION NA • n=31 Participants
|
8.56 percent of HbA1c
STANDARD_DEVIATION 0.77 • n=30 Participants
|
8.05 percent of HbA1c
STANDARD_DEVIATION 0.86 • n=3 Participants
|
8.29 percent of HbA1c
STANDARD_DEVIATION 0.84 • n=6 Participants
|
|
Fasting Serum Glucose (FSG)
FSG Part A
|
164.43 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 31.59 • n=99 Participants
|
148.08 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 19.14 • n=107 Participants
|
181.27 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 47.84 • n=206 Participants
|
175.74 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 75.99 • n=7 Participants
|
145.66 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 23.22 • n=31 Participants
|
NA milligram/deciliter (mg/dL)
STANDARD_DEVIATION NA • n=30 Participants
|
NA milligram/deciliter (mg/dL)
STANDARD_DEVIATION NA • n=3 Participants
|
161.63 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 42.87 • n=6 Participants
|
|
Fasting Serum Glucose (FSG)
FSG Part B
|
NA milligram/deciliter (mg/dL)
STANDARD_DEVIATION NA • n=99 Participants
|
NA milligram/deciliter (mg/dL)
STANDARD_DEVIATION NA • n=107 Participants
|
NA milligram/deciliter (mg/dL)
STANDARD_DEVIATION NA • n=206 Participants
|
NA milligram/deciliter (mg/dL)
STANDARD_DEVIATION NA • n=7 Participants
|
NA milligram/deciliter (mg/dL)
STANDARD_DEVIATION NA • n=31 Participants
|
159.73 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 36.54 • n=30 Participants
|
152.22 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 26.62 • n=3 Participants
|
155.78 milligram/deciliter (mg/dL)
STANDARD_DEVIATION 31.02 • n=6 Participants
|
PRIMARY outcome
Timeframe: Predose on Day 1 up to Day 56 in each PartPopulation: All randomized participants who received at least one dose of study drug.
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Placebo Part A
n=11 Participants
Part A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
|
0.5 mg LY3025876
n=15 Participants
Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
1.5 mg LY3025876
n=8 Participants
Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
5.0 mg LY3025876
n=9 Participants
Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
15 mg LY3025876
n=10 Participants
Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo + Liraglutide
n=9 Participants
Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
5.0 mg LY3025876 + Liraglutide
n=10 Participants
Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr PostdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable AUC 0-24 PK data.
AUC(0-24) of individual participants was calculated by equation Area Under Concentration (AUC)=Dose/CL, where the clearance (CL) was estimated using a population PK model.
Outcome measures
| Measure |
Placebo Part A
n=15 Participants
Part A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
|
0.5 mg LY3025876
n=8 Participants
Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
1.5 mg LY3025876
n=9 Participants
Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
5.0 mg LY3025876
n=8 Participants
Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
15 mg LY3025876
n=10 Participants
Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo + Liraglutide
Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
5.0 mg LY3025876 + Liraglutide
Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876
|
51.5 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 61.1
|
207 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 51.2
|
622 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 42.3
|
1930 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 32.4
|
525 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr PostdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable Cmax PK data.
Outcome measures
| Measure |
Placebo Part A
n=14 Participants
Part A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
|
0.5 mg LY3025876
n=8 Participants
Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
1.5 mg LY3025876
n=9 Participants
Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
5.0 mg LY3025876
n=10 Participants
Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
15 mg LY3025876
n=9 Participants
Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo + Liraglutide
Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
5.0 mg LY3025876 + Liraglutide
Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
|---|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of LY3025876
Day 1
|
3.90 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 33.7
|
17.5 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 43.7
|
45.1 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 39.2
|
126 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 44.3
|
40.3 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 48.3
|
—
|
—
|
|
PK: Maximum Concentration (Cmax) of LY3025876
Day 28
|
4.87 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 85.7
|
14.2 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 46.1
|
51.9 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 31.3
|
185 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 26.8
|
44.8 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 53.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose on Day 7, 14, 28, 56, and 180Population: All randomized participants who received at least one dose of study drug in Part A and Part B.
Outcome measures
| Measure |
Placebo Part A
n=11 Participants
Part A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
|
0.5 mg LY3025876
n=15 Participants
Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
1.5 mg LY3025876
n=8 Participants
Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
5.0 mg LY3025876
n=9 Participants
Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
15 mg LY3025876
n=10 Participants
Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo + Liraglutide
n=9 Participants
Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
5.0 mg LY3025876 + Liraglutide
n=10 Participants
Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
|---|---|---|---|---|---|---|---|
|
Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies
Positive Antibodies Day 14
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies
Positive Antibodies Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies
Positive Antibodies Day 28
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies
Positive Antibodies Day 56
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
|
Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies
Positive Antibodies Day 180
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 28Population: All randomized participants who received one dose of study drug and had evaluable PD data baseline and at least 1 post-baseline data in fasting glucose.
Least Squares Mean (LS) Mean change from baseline in fasting glucose was modeled using Mixed Effect Model Repeat Measurement (MMRM) analysis with fixed effects of baseline, treatment, day, treatment\*day interaction, and participant as a random effect.
Outcome measures
| Measure |
Placebo Part A
n=11 Participants
Part A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
|
0.5 mg LY3025876
n=7 Participants
Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
1.5 mg LY3025876
n=8 Participants
Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
5.0 mg LY3025876
n=9 Participants
Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
15 mg LY3025876
n=6 Participants
Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo + Liraglutide
n=8 Participants
Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
5.0 mg LY3025876 + Liraglutide
n=9 Participants
Part B: 5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose
|
3.52 milligram/deciliter (mg/dL)
Standard Error 8.41
|
18.08 milligram/deciliter (mg/dL)
Standard Error 10.02
|
0.12 milligram/deciliter (mg/dL)
Standard Error 9.92
|
-14.50 milligram/deciliter (mg/dL)
Standard Error 9.33
|
22.96 milligram/deciliter (mg/dL)
Standard Error 11.51
|
11.72 milligram/deciliter (mg/dL)
Standard Error 5.94
|
6.32 milligram/deciliter (mg/dL)
Standard Error 5.64
|
Adverse Events
Placebo Part A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
0.5 mg LY3025876
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
1.5 mg LY3025876
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
5.0 mg LY3025876
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
15 mg LY3025876
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Part B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo + Liraglutide
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo Part A
n=11 participants at risk
Part A: Placebo for LY3025876 administered as QD SQ injections for up to 28 days.
|
0.5 mg LY3025876
n=15 participants at risk
Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
1.5 mg LY3025876
n=8 participants at risk
Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
5.0 mg LY3025876
n=9 participants at risk
Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
15 mg LY3025876
n=10 participants at risk
Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo Part B
n=9 participants at risk
Part B: Placebo matching LY3025876 administered as QD SQ injections for up to 28 days.
|
Placebo + Liraglutide
n=10 participants at risk
Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
9.1%
1/11 • Number of events 1
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11
|
6.7%
1/15 • Number of events 1
|
12.5%
1/8 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
90.0%
9/10 • Number of events 10
|
0.00%
0/9
|
30.0%
3/10 • Number of events 4
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
22.2%
2/9 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Frequent bowel movements
|
9.1%
1/11 • Number of events 1
|
0.00%
0/15
|
25.0%
2/8 • Number of events 2
|
66.7%
6/9 • Number of events 6
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
30.0%
3/10 • Number of events 3
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11
|
0.00%
0/15
|
12.5%
1/8 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
30.0%
3/10 • Number of events 3
|
44.4%
4/9 • Number of events 5
|
40.0%
4/10 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
22.2%
2/9 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Asthenia
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Early satiety
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
40.0%
4/10 • Number of events 5
|
|
General disorders
Feeling cold
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Feeling hot
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
20.0%
2/10 • Number of events 2
|
|
General disorders
Injection site bruising
|
9.1%
1/11 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
General disorders
Injection site erosion
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Injection site erythema
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
40.0%
4/10 • Number of events 14
|
22.2%
2/9 • Number of events 3
|
20.0%
2/10 • Number of events 8
|
|
General disorders
Injection site haemorrhage
|
9.1%
1/11 • Number of events 1
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
44.4%
4/9 • Number of events 4
|
10.0%
1/10 • Number of events 2
|
|
General disorders
Injection site mass
|
0.00%
0/11
|
0.00%
0/15
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
General disorders
Injection site pain
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Injection site pruritus
|
0.00%
0/11
|
6.7%
1/15 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
0.00%
0/9
|
40.0%
4/10 • Number of events 5
|
11.1%
1/9 • Number of events 2
|
10.0%
1/10 • Number of events 5
|
|
General disorders
Injection site rash
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
40.0%
4/10 • Number of events 4
|
|
General disorders
Injection site reaction
|
0.00%
0/11
|
0.00%
0/15
|
25.0%
2/8 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
General disorders
Temperature intolerance
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11
|
0.00%
0/15
|
25.0%
2/8 • Number of events 2
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
20.0%
2/10 • Number of events 2
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/11
|
0.00%
0/15
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
1/11 • Number of events 1
|
0.00%
0/15
|
25.0%
2/8 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11
|
0.00%
0/15
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/11
|
6.7%
1/15 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11
|
6.7%
1/15 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
44.4%
4/9 • Number of events 4
|
50.0%
5/10 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.1%
1/11 • Number of events 8
|
0.00%
0/15
|
12.5%
1/8 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
22.2%
2/9 • Number of events 3
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11
|
0.00%
0/15
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11
|
6.7%
1/15 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11
|
6.7%
1/15 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/11
|
6.7%
1/15 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Number of events 1
|
0.00%
0/15
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/11
|
0.00%
0/15
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1
|
0.00%
0/15
|
12.5%
1/8 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Tremor
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Food aversion
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/11
|
0.00%
0/15
|
37.5%
3/8 • Number of events 4
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/11
|
0.00%
0/15
|
12.5%
1/8 • Number of events 1
|
0.00%
0/9
|
0.00%
0/10
|
11.1%
1/9 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/11
|
6.7%
1/15 • Number of events 1
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/10
|
0.00%
0/9
|
0.00%
0/10
|
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