Trial Outcomes & Findings for A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (NCT NCT05563246)
NCT ID: NCT05563246
Last Updated: 2025-03-25
Results Overview
Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
233 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2025-03-25
Participant Flow
Participant milestones
| Measure |
10 mg LY3473329
Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period.
|
60 mg LY3473329
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
64
|
68
|
67
|
|
Overall Study
Received at Least One Dose of Study Drug
|
34
|
63
|
68
|
67
|
|
Overall Study
COMPLETED
|
33
|
60
|
65
|
67
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
3
|
0
|
Reasons for withdrawal
| Measure |
10 mg LY3473329
Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period.
|
60 mg LY3473329
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
All randomized participants who had non-missing baseline Lp(a) data, as assessed by the intact Lp(a) assay. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage.
Baseline characteristics by cohort
| Measure |
10 mg LY3473329
n=34 Participants
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=64 Participants
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=68 Participants
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
n=67 Participants
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
Total
n=233 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.06 years
STANDARD_DEVIATION 10.01 • n=34 Participants
|
65.50 years
STANDARD_DEVIATION 9.36 • n=64 Participants
|
64.75 years
STANDARD_DEVIATION 9.35 • n=68 Participants
|
62.78 years
STANDARD_DEVIATION 9.93 • n=67 Participants
|
64.29 years
STANDARD_DEVIATION 9.61 • n=233 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=34 Participants
|
22 Participants
n=64 Participants
|
24 Participants
n=68 Participants
|
19 Participants
n=67 Participants
|
76 Participants
n=233 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=34 Participants
|
42 Participants
n=64 Participants
|
44 Participants
n=68 Participants
|
48 Participants
n=67 Participants
|
157 Participants
n=233 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=34 Participants
|
11 Participants
n=64 Participants
|
10 Participants
n=68 Participants
|
9 Participants
n=67 Participants
|
34 Participants
n=233 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=34 Participants
|
50 Participants
n=64 Participants
|
57 Participants
n=68 Participants
|
58 Participants
n=67 Participants
|
195 Participants
n=233 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
3 Participants
n=64 Participants
|
1 Participants
n=68 Participants
|
0 Participants
n=67 Participants
|
4 Participants
n=233 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=233 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=34 Participants
|
17 Participants
n=64 Participants
|
19 Participants
n=68 Participants
|
18 Participants
n=67 Participants
|
63 Participants
n=233 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=34 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=67 Participants
|
1 Participants
n=233 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=34 Participants
|
5 Participants
n=64 Participants
|
1 Participants
n=68 Participants
|
1 Participants
n=67 Participants
|
9 Participants
n=233 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=34 Participants
|
41 Participants
n=64 Participants
|
45 Participants
n=68 Participants
|
45 Participants
n=67 Participants
|
153 Participants
n=233 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=34 Participants
|
1 Participants
n=64 Participants
|
3 Participants
n=68 Participants
|
3 Participants
n=67 Participants
|
7 Participants
n=233 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=34 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=67 Participants
|
0 Participants
n=233 Participants
|
|
Region of Enrollment
Australia
|
6 Participants
n=34 Participants
|
12 Participants
n=64 Participants
|
12 Participants
n=68 Participants
|
12 Participants
n=67 Participants
|
42 Participants
n=233 Participants
|
|
Region of Enrollment
Brazil
|
6 Participants
n=34 Participants
|
13 Participants
n=64 Participants
|
12 Participants
n=68 Participants
|
12 Participants
n=67 Participants
|
43 Participants
n=233 Participants
|
|
Region of Enrollment
China
|
4 Participants
n=34 Participants
|
8 Participants
n=64 Participants
|
9 Participants
n=68 Participants
|
9 Participants
n=67 Participants
|
30 Participants
n=233 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=34 Participants
|
5 Participants
n=64 Participants
|
8 Participants
n=68 Participants
|
7 Participants
n=67 Participants
|
24 Participants
n=233 Participants
|
|
Region of Enrollment
Hungary
|
6 Participants
n=34 Participants
|
11 Participants
n=64 Participants
|
11 Participants
n=68 Participants
|
11 Participants
n=67 Participants
|
39 Participants
n=233 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=34 Participants
|
8 Participants
n=64 Participants
|
8 Participants
n=68 Participants
|
9 Participants
n=67 Participants
|
29 Participants
n=233 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=34 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=68 Participants
|
4 Participants
n=67 Participants
|
12 Participants
n=233 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=34 Participants
|
4 Participants
n=64 Participants
|
5 Participants
n=68 Participants
|
3 Participants
n=67 Participants
|
14 Participants
n=233 Participants
|
|
Lp(a) - Assessed via Intact Lp(a) Assay
|
220.99 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 60.39 • n=28 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the intact Lp(a) assay. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage.
|
223.47 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 97.36 • n=52 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the intact Lp(a) assay. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage.
|
242.42 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 100.18 • n=57 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the intact Lp(a) assay. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage.
|
250.53 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 96.66 • n=57 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the intact Lp(a) assay. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage.
|
236.63 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 93.74 • n=194 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the intact Lp(a) assay. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage.
|
|
Lp(a) - Assessed via Apo(a) Assay
|
269.67 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 78.10 • n=34 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the apo(a) assay.
|
256.28 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 96.55 • n=63 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the apo(a) assay.
|
273.84 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 90.68 • n=68 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the apo(a) assay.
|
265.30 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 85.80 • n=67 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the apo(a) assay.
|
265.99 nanomoles per liter (nmol/L)
STANDARD_DEVIATION 88.93 • n=232 Participants • All randomized participants who had non-missing baseline Lp(a) data, as assessed by the apo(a) assay.
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of the study drug had a non-missing baseline value and at least one post-baseline value, as assessed by the intact Lp(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage.
Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.
Outcome measures
| Measure |
10 mg LY3473329
n=23 Participants
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=45 Participants
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=47 Participants
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
n=49 Participants
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay
|
-47.35 Percent change
Standard Error 4.811
|
-81.57 Percent change
Standard Error 1.230
|
-85.71 Percent change
Standard Error 0.927
|
0.48 Percent change
Standard Error 6.382
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of the study drug, had a non-missing baseline value, and at least one post-baseline value, as assessed by the apo(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication.
LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment\*Time.
Outcome measures
| Measure |
10 mg LY3473329
n=29 Participants
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=56 Participants
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=57 Participants
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
n=60 Participants
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay
|
-42.26 Percent change
Standard Error 4.477
|
-70.90 Percent change
Standard Error 1.669
|
-69.88 Percent change
Standard Error 1.676
|
-3.15 Percent change
Standard Error 5.342
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of the study drug and had a non-missing baseline value, as assessed by the intact Lp(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication. As pre-specified in the statistical analysis plan, intact Lp(a) assay measurements were not collected from participants at Chinese sites due to country-specific restrictions on sample storage.
The percentage of participants who achieved Lp(a) less than (\<) 125 nmol/L, as measured using the intact Lp(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.
Outcome measures
| Measure |
10 mg LY3473329
n=23 Participants
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=45 Participants
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=47 Participants
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
n=49 Participants
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay
|
69.6 Percentage of participants
|
95.6 Percentage of participants
|
95.7 Percentage of participants
|
6.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least one dose of the study drug and had a non-missing baseline value, as assessed by the apo(a) assay, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication.
The percentage of participants who achieved Lp(a) \< 125 nmol/L, as measured using the apo(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.
Outcome measures
| Measure |
10 mg LY3473329
n=29 Participants
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=56 Participants
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=57 Participants
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
n=60 Participants
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay
|
37.9 Percentage of participants
|
82.1 Percentage of participants
|
77.2 Percentage of participants
|
3.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of the study drug and had a non-missing baseline value and at least one post-baseline value for this outcome, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication.
LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment\*Time.
Outcome measures
| Measure |
10 mg LY3473329
n=29 Participants
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=56 Participants
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=57 Participants
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
n=60 Participants
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein B (ApoB)
|
-10.49 Percent change
Standard Error 4.349
|
-14.53 Percent change
Standard Error 3.055
|
-17.56 Percent change
Standard Error 2.877
|
-1.70 Percent change
Standard Error 3.362
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: All randomized participants who received at least one dose of the study drug and had a non-missing baseline value and at least one post-baseline value for this outcome, excluding data after discontinuation of the study drug or initiation of new Lp(a) modifying medication.
LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment\*Time.
Outcome measures
| Measure |
10 mg LY3473329
n=29 Participants
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=56 Participants
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=57 Participants
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
n=58 Participants
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
|
21.87 Percent change
Standard Error 20.029
|
-2.41 Percent change
Standard Error 11.713
|
-15.39 Percent change
Standard Error 9.921
|
-9.91 Percent change
Standard Error 10.526
|
SECONDARY outcome
Timeframe: Week from randomization 1, 2, 8, 12: Pre-dosePopulation: All randomized participants who received at least one dose of the study drug and had evaluable PK samples for the relevant weeks were included in this outcome analysis.
C-trough were measured at specified time points to assess the minimum concentration of LY3473329 in the blood before the next dose was administered.
Outcome measures
| Measure |
10 mg LY3473329
n=33 Participants
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=60 Participants
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=66 Participants
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329
Week 1
|
13.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 81
|
42.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 79
|
83.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 70
|
—
|
|
Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329
Week 2
|
14.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 73
|
39.3 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 76
|
77.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 62
|
—
|
|
Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329
Week 8
|
14.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 67
|
38.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 89
|
73.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 110
|
—
|
|
Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329
Week 12
|
15.4 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 64
|
37.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 95
|
74.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 111
|
—
|
Adverse Events
10 mg LY3473329
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
60 mg LY3473329
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
240 mg LY3473329
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mg LY3473329
n=34 participants at risk
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=63 participants at risk
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=68 participants at risk
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
n=67 participants at risk
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/67 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
2.9%
1/34 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/67 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
2.9%
1/34 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Priapism
|
0.00%
0/23 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/41 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
2.3%
1/44 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/48 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/67 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Vascular disorders
Peripheral vascular haematoma
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/67 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Other adverse events
| Measure |
10 mg LY3473329
n=34 participants at risk
Participants received 10 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
60 mg LY3473329
n=63 participants at risk
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
240 mg LY3473329
n=68 participants at risk
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
|
Placebo
n=67 participants at risk
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
2/34 • Number of events 2 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
4/68 • Number of events 4 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
6.0%
4/67 • Number of events 4 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
2/34 • Number of events 2 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
4.5%
3/67 • Number of events 3 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Infections and infestations
Influenza
|
5.9%
2/34 • Number of events 3 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/67 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/34 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.2%
2/63 • Number of events 3 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.9%
4/68 • Number of events 4 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/67 • Number of events 2 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 2 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/63 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/68 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
3.0%
2/67 • Number of events 2 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
2/34 • Number of events 2 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.6%
1/63 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
1.5%
1/68 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/67 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/11 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/22 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
0.00%
0/24 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
5.3%
1/19 • Number of events 1 • Baseline to end of follow-up (up to 16 weeks)
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60