Trial Outcomes & Findings for A Study of LY3502970 in Participants With Type 2 Diabetes (NCT NCT04426474)
NCT ID: NCT04426474
Last Updated: 2026-05-26
Results Overview
An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations based on medical judgement. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
Baseline through Follow-up (up to Day 105)
Results posted on
2026-05-26
Participant Flow
Participant milestones
| Measure |
3/6/9 mg LY3502970 QD
Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/15 mg LY3502970 QD
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/21/27 mg LY3502970 QD
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
Placebo QD
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
Participants received 3 milligrams (mg), 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
9
|
9
|
17
|
14
|
|
Overall Study
Received at Least One Dose of Study Drug
|
9
|
10
|
9
|
9
|
17
|
14
|
|
Overall Study
COMPLETED
|
9
|
9
|
8
|
9
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
6
|
8
|
Reasons for withdrawal
| Measure |
3/6/9 mg LY3502970 QD
Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/15 mg LY3502970 QD
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/21/27 mg LY3502970 QD
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
Placebo QD
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
Participants received 3 milligrams (mg), 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
A Study of LY3502970 in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
3/6/12/21/27 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
Total
n=68 Participants
Total of all reporting groups
|
Placebo QD
n=17 Participants
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
n=14 Participants
Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/15 mg LY3502970 QD
n=10 Participants
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
STANDARD_DEVIATION 4.6 • n=52 Participants
|
62.8 years
STANDARD_DEVIATION 4.4 • n=6 Participants
|
57.9 years
STANDARD_DEVIATION 6.3 • n=6 Participants
|
56.0 years
STANDARD_DEVIATION 6.0 • n=20 Participants
|
55.3 years
STANDARD_DEVIATION 8.0 • n=32 Participants
|
57.7 years
STANDARD_DEVIATION 6.4 • n=64 Participants
|
59.6 years
STANDARD_DEVIATION 4.6 • n=50 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=52 Participants
|
5 Participants
n=6 Participants
|
26 Participants
n=6 Participants
|
7 Participants
n=20 Participants
|
4 Participants
n=32 Participants
|
5 Participants
n=64 Participants
|
3 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=52 Participants
|
4 Participants
n=6 Participants
|
42 Participants
n=6 Participants
|
10 Participants
n=20 Participants
|
10 Participants
n=32 Participants
|
4 Participants
n=64 Participants
|
7 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=52 Participants
|
5 Participants
n=6 Participants
|
30 Participants
n=6 Participants
|
7 Participants
n=20 Participants
|
8 Participants
n=32 Participants
|
4 Participants
n=64 Participants
|
3 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=52 Participants
|
4 Participants
n=6 Participants
|
38 Participants
n=6 Participants
|
10 Participants
n=20 Participants
|
6 Participants
n=32 Participants
|
5 Participants
n=64 Participants
|
7 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=52 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=52 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=52 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=52 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=52 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=6 Participants
|
2 Participants
n=20 Participants
|
4 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
2 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=52 Participants
|
8 Participants
n=6 Participants
|
58 Participants
n=6 Participants
|
14 Participants
n=20 Participants
|
10 Participants
n=32 Participants
|
9 Participants
n=64 Participants
|
8 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=52 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=52 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=50 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=52 Participants
|
5 Participants
n=6 Participants
|
40 Participants
n=6 Participants
|
10 Participants
n=20 Participants
|
14 Participants
n=32 Participants
|
4 Participants
n=64 Participants
|
4 Participants
n=50 Participants
|
|
Region of Enrollment
Germany
|
6 Participants
n=52 Participants
|
4 Participants
n=6 Participants
|
28 Participants
n=6 Participants
|
7 Participants
n=20 Participants
|
0 Participants
n=32 Participants
|
5 Participants
n=64 Participants
|
6 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline through Follow-up (up to Day 105)Population: All participants who received at least one dose of study drug.
An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations based on medical judgement. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Outcome measures
| Measure |
3/6/12/15 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/21/27 mg LY3502970 QD
n=10 Participants
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
Placebo QD
n=17 Participants
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
n=14 Participants
Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24, 48, 96 Hours PostdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
Outcome measures
| Measure |
3/6/12/15 mg LY3502970 QD
n=8 Participants
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/21/27 mg LY3502970 QD
n=8 Participants
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=3 Participants
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
Placebo QD
n=6 Participants
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
n=7 Participants
Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
|
97.9 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
191 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 59
|
218 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
101 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
57.9 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 78
|
—
|
SECONDARY outcome
Timeframe: Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24 Hours PostdosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: area under the concentration versus time curve from time 0 to 24 hours \[AUC(0-24)\] of LY3502970
Outcome measures
| Measure |
3/6/12/15 mg LY3502970 QD
n=8 Participants
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/21/27 mg LY3502970 QD
n=8 Participants
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=3 Participants
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
Placebo QD
n=5 Participants
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
n=7 Participants
Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of LY3502970
|
1600 nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 29
|
3120 nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 53
|
3520 nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 29
|
1480 nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
|
850 nanograms hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 73
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All participants who received at least one dose of study drug and had a baseline and at least one post baseline FPG value.
Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG).
Outcome measures
| Measure |
3/6/12/15 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/21/27 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=8 Participants
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
Placebo QD
n=12 Participants
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
n=7 Participants
Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG)
|
-3.00 millimoles per litre (mmol/L)
Standard Error 0.54
|
-2.85 millimoles per litre (mmol/L)
Standard Error 0.55
|
-2.42 millimoles per litre (mmol/L)
Standard Error 0.57
|
-1.14 millimoles per litre (mmol/L)
Standard Error 0.47
|
-2.02 millimoles per litre (mmol/L)
Standard Error 0.60
|
-2.29 millimoles per litre (mmol/L)
Standard Error 0.55
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All participants who received at least one dose of study drug and had a baseline and at least one post baseline fasting insulin value.
PD: Change From Baseline to Week 12 in Fasting Insulin.
Outcome measures
| Measure |
3/6/12/15 mg LY3502970 QD
n=8 Participants
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/21/27 mg LY3502970 QD
n=9 Participants
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=8 Participants
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
Placebo QD
n=11 Participants
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
n=7 Participants
Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=8 Participants
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|
|
PD: Change From Baseline to Week 12 in Fasting Insulin
|
-5.46 picomoles/litre (pmol/L)
Standard Error 14.48
|
15.16 picomoles/litre (pmol/L)
Standard Error 17.97
|
7.30 picomoles/litre (pmol/L)
Standard Error 17.09
|
-9.71 picomoles/litre (pmol/L)
Standard Error 11.14
|
-12.20 picomoles/litre (pmol/L)
Standard Error 13.13
|
-1.32 picomoles/litre (pmol/L)
Standard Error 15.63
|
Adverse Events
Placebo QD
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
3/6/12/21 mg LY3502970 QD
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
3/6/9 mg LY3502970 QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
3/6/12/15 mg LY3502970 QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
3/6/12/21/27 mg LY3502970 QD
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
3/6/9/21/36/45 mg LY3502970 QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo QD
n=17 participants at risk
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
n=14 participants at risk
Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9 mg LY3502970 QD
n=9 participants at risk
Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/15 mg LY3502970 QD
n=10 participants at risk
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/21/27 mg LY3502970 QD
n=9 participants at risk
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=9 participants at risk
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Hand fracture
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo QD
n=17 participants at risk
Participants received placebo administered once daily (QD) as oral daily dosing over 12 weeks.
|
3/6/12/21 mg LY3502970 QD
n=14 participants at risk
Participants received 3 mg, 6 mg,12 mg and 21 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9 mg LY3502970 QD
n=9 participants at risk
Participants received 3 mg, 6 mg and 9 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/15 mg LY3502970 QD
n=10 participants at risk
Participants received 3 mg, 6 mg,12 mg and 15 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/12/21/27 mg LY3502970 QD
n=9 participants at risk
Participants received 3 mg, 6 mg,12 mg, 21 mg and 27 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
3/6/9/21/36/45 mg LY3502970 QD
n=9 participants at risk
Participants received 3 mg, 6 mg, 9 mg, 21 mg, 36 mg and 45 mg LY3502970 administered QD as oral daily dosing with weekly titration for the length of 12 weeks.
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Bundle branch block left
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
33.3%
3/9 • Number of events 3 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
3/17 • Number of events 5 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 3 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
33.3%
3/9 • Number of events 3 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
30.0%
3/10 • Number of events 3 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
42.9%
6/14 • Number of events 7 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
44.4%
4/9 • Number of events 4 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
50.0%
5/10 • Number of events 8 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
33.3%
3/9 • Number of events 4 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
77.8%
7/9 • Number of events 12 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
14.3%
2/14 • Number of events 4 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
55.6%
5/9 • Number of events 23 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
50.0%
5/10 • Number of events 11 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
55.6%
5/9 • Number of events 12 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
55.6%
5/9 • Number of events 24 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
General disorders
Early satiety
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
20.0%
2/10 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
General disorders
Vaccination site pain
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Covid-19
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
21.4%
3/14 • Number of events 3 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Root canal infection
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Investigations
Blood urea increased
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram pr prolongation
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
2/17 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
28.6%
4/14 • Number of events 4 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
44.4%
4/9 • Number of events 4 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
40.0%
4/10 • Number of events 4 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
55.6%
5/9 • Number of events 5 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
66.7%
6/9 • Number of events 6 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Food aversion
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Drug withdrawal headache
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 2 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
30.0%
3/10 • Number of events 4 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
22.2%
2/9 • Number of events 3 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
7.1%
1/14 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Listless
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/17 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/14 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/10 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline through Follow-up (up to Day 105)
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60