Trial Outcomes & Findings for Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain (NCT NCT04455633)
NCT ID: NCT04455633
Last Updated: 2025-06-25
Results Overview
ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
319 participants
Primary outcome timeframe
Baseline (Week 2 of the Run-in period) to Week 6
Results posted on
2025-06-25
Participant Flow
Participants took part in the study at multiple investigative sites in the United States from 03 Sep 2020 to 28 Jun 2022.
Participants with diagnosis of diabetic peripheral neuropathic pain were randomized in a 1:1:1 ratio to Placebo, LX9211 100 milligrams (mg)/10 mg and LX9211 200 mg/20 mg arm groups.
Participant milestones
| Measure |
Placebo
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, once daily (QD) from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
|---|---|---|---|
|
Double-Blind Period (Up to Week 6)
STARTED
|
107
|
106
|
106
|
|
Double-Blind Period (Up to Week 6)
COMPLETED
|
101
|
85
|
70
|
|
Double-Blind Period (Up to Week 6)
NOT COMPLETED
|
6
|
21
|
36
|
|
Follow up Period (Weeks 7 to 11)
STARTED
|
104
|
99
|
92
|
|
Follow up Period (Weeks 7 to 11)
COMPLETED
|
103
|
99
|
92
|
|
Follow up Period (Weeks 7 to 11)
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, once daily (QD) from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
|---|---|---|---|
|
Double-Blind Period (Up to Week 6)
Adverse Event
|
4
|
17
|
28
|
|
Double-Blind Period (Up to Week 6)
Subject Choice Unrelated to Adverse Event/Serious Adverse Event
|
2
|
2
|
6
|
|
Double-Blind Period (Up to Week 6)
Other, not specified
|
0
|
2
|
2
|
|
Follow up Period (Weeks 7 to 11)
Other, not specified
|
1
|
0
|
0
|
Baseline Characteristics
The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. "Number analyzed" indicates number of participants with data available for analysis at Baseline.
Baseline characteristics by cohort
| Measure |
Placebo
n=107 Participants
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
Total
n=319 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.0 years
STANDARD_DEVIATION 9.59 • n=107 Participants
|
62.8 years
STANDARD_DEVIATION 9.26 • n=106 Participants
|
61.8 years
STANDARD_DEVIATION 10.96 • n=106 Participants
|
62.2 years
STANDARD_DEVIATION 9.94 • n=319 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=107 Participants
|
48 Participants
n=106 Participants
|
43 Participants
n=106 Participants
|
132 Participants
n=319 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=107 Participants
|
58 Participants
n=106 Participants
|
63 Participants
n=106 Participants
|
187 Participants
n=319 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=107 Participants
|
13 Participants
n=106 Participants
|
18 Participants
n=106 Participants
|
54 Participants
n=319 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
84 Participants
n=107 Participants
|
93 Participants
n=106 Participants
|
88 Participants
n=106 Participants
|
265 Participants
n=319 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=319 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=107 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=106 Participants
|
2 Participants
n=319 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=107 Participants
|
3 Participants
n=106 Participants
|
1 Participants
n=106 Participants
|
5 Participants
n=319 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=107 Participants
|
2 Participants
n=106 Participants
|
0 Participants
n=106 Participants
|
2 Participants
n=319 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=107 Participants
|
22 Participants
n=106 Participants
|
18 Participants
n=106 Participants
|
59 Participants
n=319 Participants
|
|
Race/Ethnicity, Customized
White
|
82 Participants
n=107 Participants
|
79 Participants
n=106 Participants
|
83 Participants
n=106 Participants
|
244 Participants
n=319 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=107 Participants
|
0 Participants
n=106 Participants
|
4 Participants
n=106 Participants
|
7 Participants
n=319 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=319 Participants
|
|
Average Daily Pain Score (ADPS)
|
6.54 score on a scale
STANDARD_DEVIATION 1.154 • n=106 Participants • The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. "Number analyzed" indicates number of participants with data available for analysis at Baseline.
|
6.59 score on a scale
STANDARD_DEVIATION 1.091 • n=106 Participants • The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. "Number analyzed" indicates number of participants with data available for analysis at Baseline.
|
6.53 score on a scale
STANDARD_DEVIATION 1.028 • n=104 Participants • The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. "Number analyzed" indicates number of participants with data available for analysis at Baseline.
|
6.55 score on a scale
STANDARD_DEVIATION 1.089 • n=316 Participants • The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. "Number analyzed" indicates number of participants with data available for analysis at Baseline.
|
PRIMARY outcome
Timeframe: Baseline (Week 2 of the Run-in period) to Week 6Population: The modified intent to treat (mITT) population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. 'Overall number of participants analyzed' indicates the number of participants data available for the analysis of this outcome measure.
ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=99 Participants
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
n=87 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
n=77 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
Placebo (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating Scale
|
-0.72 score on a scale
Interval -1.08 to -0.36
|
-1.39 score on a scale
Interval -1.77 to -1.01
|
-1.27 score on a scale
Interval -1.66 to -0.88
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 2 of the Run-in period) to Week 6Population: The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Missing observations at Week 6 are imputed as nonresponses.
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-30) then participant was considered a Responder and if missing % change from Baseline or \>(-30) participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥30% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.
Outcome measures
| Measure |
Placebo
n=107 Participants
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
Placebo (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6
|
17.8 percentage of participants
|
27.4 percentage of participants
|
17.0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 2 of the Run-in period) to Week 6Population: The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Missing observations at Week 6 are imputed as nonresponses.
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-50) then participant is considered a Responder and if missing % change from Baseline or \>(-50) then participant is considered a Non-responder. Percentage of participants who were responders (who achieved ≥50% reduction in pain intensity in ADPS from Baseline to Week 6) are reported.
Outcome measures
| Measure |
Placebo
n=107 Participants
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
Placebo (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6
|
10.3 percentage of participants
|
15.1 percentage of participants
|
9.4 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 2 of the Run-in period) to Week 6Population: The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Overall number of participants analyzed' indicates the number of participants evaluable for the outcome measure analysis. Number analyzed indicates the number of participants evaluable for the outcome measure for the specified category.
BPI-DPN: questionnaire that assesses severity of pain \& its impact on functioning in participants with DPN. It consists of 4 questions that measure pain at its "worst,"least","average","now"(current pain) on 11-point numerical scale 0=no pain;10=worst pain.Score range:0-10 for each of these pain questions, higher scores=greater pain severity. Other 7 questions of BPI evaluate level of interference of pain on daily functioning (general activity,walking,work ability,mood,enjoyment of life,relations,sleep) on 11-point numerical scale, 0=does not interfere;10=completely interferes.Score range:0-10 for each of these intensity questions, higher scores=greater interference. Pain severity \& pain interference factors are reported as separate categories. Average interference score= mean of 7 interference categories collected in Questions 9A-G, only if 50% (ie at least 4 of 7) of scores were non-missing. Negative change from baseline=improvement. Score range for average interference score: 0-70.
Outcome measures
| Measure |
Placebo
n=89 Participants
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
n=77 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
n=86 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
Placebo (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Pain at its Worst
|
-0.69 score on a scale
Interval -1.11 to -0.26
|
-1.42 score on a scale
Interval -1.87 to -0.97
|
-1.38 score on a scale
Interval -1.81 to -0.96
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Pain at its Least
|
-0.69 score on a scale
Interval -1.13 to -0.26
|
-1.43 score on a scale
Interval -1.89 to -0.98
|
-1.38 score on a scale
Interval -1.81 to -0.95
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Pain Right Now
|
-0.55 score on a scale
Interval -1.0 to -0.1
|
-1.42 score on a scale
Interval -1.89 to -0.95
|
-1.03 score on a scale
Interval -1.47 to -0.59
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Interference Score Averaged Over Questions 9A - G
|
-0.74 score on a scale
Interval -1.17 to -0.3
|
-1.00 score on a scale
Interval -1.46 to -0.53
|
-0.97 score on a scale
Interval -1.41 to -0.53
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
General Activity
|
-0.77 score on a scale
Interval -1.25 to -0.28
|
-0.96 score on a scale
Interval -1.48 to -0.44
|
-0.82 score on a scale
Interval -1.31 to -0.33
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Mood
|
-0.71 score on a scale
Interval -1.22 to -0.19
|
-0.72 score on a scale
Interval -1.27 to -0.16
|
-0.65 score on a scale
Interval -1.18 to -0.13
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Walking Ability
|
-0.74 score on a scale
Interval -1.24 to -0.24
|
-1.36 score on a scale
Interval -1.89 to -0.83
|
-1.22 score on a scale
Interval -1.73 to -0.72
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Normal Work
|
-1.01 score on a scale
Interval -1.5 to -0.53
|
-1.07 score on a scale
Interval -1.58 to -0.55
|
-1.05 score on a scale
Interval -1.54 to -0.56
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Relations with Other People
|
-0.29 score on a scale
Interval -0.79 to 0.2
|
0.14 score on a scale
Interval -0.39 to 0.67
|
-0.09 score on a scale
Interval -0.59 to 0.41
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Sleep
|
-0.48 score on a scale
Interval -0.96 to -0.01
|
-1.45 score on a scale
Interval -1.96 to -0.94
|
-1.52 score on a scale
Interval -2.0 to -1.04
|
—
|
—
|
—
|
|
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPN
Enjoyment of Life
|
-1.03 score on a scale
Interval -1.53 to -0.52
|
-1.05 score on a scale
Interval -1.59 to -0.5
|
-1.13 score on a scale
Interval -1.64 to -0.61
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 2 of the Run-in period) to Week 6Population: The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment.
Lack of efficacy was defined as an increase of 30% from baseline in ADPS based on question 5 of the BPI-DPN. Baseline was defined as the average of the Week 2 Run-in period data collected by participants in the daily pain diary of BPI-DPN. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where 0 = No Pain to 10 = pain as bad as you can imagine, higher score indicates higher pain intensity.
Outcome measures
| Measure |
Placebo
n=107 Participants
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
Placebo (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Discontinuing Treatment Due to Lack of Efficacy
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 2 of the Run-in period) to Week 6Population: The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Overall number of participants analyzed indicates the number of participants evaluable for the analysis of the outcome measure.
PGIC is a 7-point rating scale that assesses participant's belief about the overall improvement experienced after the end of treatment, where 1= very much improved to 7 = very much worse. Higher score indicates worsening.
Outcome measures
| Measure |
Placebo
n=103 Participants
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
n=99 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
n=94 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
Placebo (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC) Scale Score at Week 6
|
3.28 score on a scale
Interval 3.04 to 3.52
|
2.93 score on a scale
Interval 2.69 to 3.17
|
3.13 score on a scale
Interval 2.88 to 3.38
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 6 to 11Population: The mITT population included all randomized participants who took at least 1 dose of study drug; participants were analyzed according to their randomized treatment. Participants who had ≥30% Reduction in Pain Intensity in ADPS at Week 6 were analyzed for this outcome measure.
For participants who achieved ≥30% reduction in ADPS based on Question 5 of the BPI-DPN at Week 6, the time to loss of efficacy was defined as the time from the date of Week 6 visit to the date of termination of safety follow-up due to lack of efficacy. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
Outcome measures
| Measure |
Placebo
n=11 Participants
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
n=16 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
n=10 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
Placebo (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving a ≥30% Reduction in Pain Intensity at Week 6
|
NA weeks
As none of the participants discontinued due to loss of efficacy during Weeks 6 to 11, median and full range could not be estimated.
|
NA weeks
As none of the participants discontinued due to loss of efficacy during Weeks 6 to 11, median and full range could not be estimated.
|
NA weeks
As none of the participants discontinued due to loss of efficacy during Weeks 6 to 11, median and full range could not be estimated.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose of study drug after randomization up to the end of study (up to Week 11)Population: The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. AEs were collected and reported for treatment period and safety follow up period separately.
Adverse Events (AE) is defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs that occur or worsen after the first dose of study medication.
Outcome measures
| Measure |
Placebo
n=107 Participants
Following a 2-week run-in period, participants were randomized to LX9211 matching placebo received as a single loading dose, orally, on Day 1, followed by maintenance doses of LX9211 matching placebo tablets, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during the safety follow-up.
|
LX9211 100 mg/10 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 100 mg tablet, orally, on Day 1, followed by maintenance doses of LX9211 10 mg tablet, orally, QD, from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
LX9211 200 mg/20 mg
n=106 Participants
Following a 2-week run-in period, participants were randomized to receive a single loading dose of LX9211, 200 mg orally on Day 1, followed by maintenance doses of LX9211, 20 mg, orally, QD from Day 2 up to Week 6. Following completion of the 6-week treatment, all participants were followed for safety and received single oral tablet of LX9211 matching placebo, QD, for 5 weeks during safety follow-up.
|
Placebo (Single-blind Follow-up Period)
n=104 Participants
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
n=99 Participants
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
n=92 Participants
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
32 Participants
|
57 Participants
|
54 Participants
|
15 Participants
|
21 Participants
|
18 Participants
|
Adverse Events
Placebo (Double-blind Treatment Period)
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
LX9211 100 mg/10 mg (Double-blind Treatment Period)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
LX9211 200 mg/20 mg (Double-blind Treatment Period)
Serious events: 2 serious events
Other events: 44 other events
Deaths: 1 deaths
Placebo (Single-blind Follow-up Period)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
LX9211 200 mg/20 mg Single-blind Follow-up Period)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Double-blind Treatment Period)
n=107 participants at risk
Following a 2-week single-blind Run-in period, participants were randomized to receive a single loading dose of LX9211 matching placebo tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.
|
LX9211 100 mg/10 mg (Double-blind Treatment Period)
n=106 participants at risk
Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 100 mg tablet, orally, on Day 1 and maintenance doses of 10 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.
|
LX9211 200 mg/20 mg (Double-blind Treatment Period)
n=106 participants at risk
Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.
|
Placebo (Single-blind Follow-up Period)
n=104 participants at risk
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
n=99 participants at risk
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
n=92 participants at risk
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
0.00%
0/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.94%
1/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Infections and infestations
COVID-19
|
0.93%
1/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.94%
1/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.94%
1/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.1%
1/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.1%
1/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.96%
1/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.0%
1/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
Other adverse events
| Measure |
Placebo (Double-blind Treatment Period)
n=107 participants at risk
Following a 2-week single-blind Run-in period, participants were randomized to receive a single loading dose of LX9211 matching placebo tablet, orally, on Day 1 and maintenance doses, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.
|
LX9211 100 mg/10 mg (Double-blind Treatment Period)
n=106 participants at risk
Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 100 mg tablet, orally, on Day 1 and maintenance doses of 10 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.
|
LX9211 200 mg/20 mg (Double-blind Treatment Period)
n=106 participants at risk
Following a 2-week Single-blind Run-in period, participants were randomized to receive a single loading dose of 200 mg tablet, orally, on Day 1 and maintenance doses of 20 mg, orally, once daily from Day 2 to Week 6 during the 6-week double-blind treatment period.
|
Placebo (Single-blind Follow-up Period)
n=104 participants at risk
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 100 mg/10 mg (Single-blind Follow-up Period)
n=99 participants at risk
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
LX9211 200 mg/20 mg Single-blind Follow-up Period)
n=92 participants at risk
Following completion of the 6-week double-blind treatment period, all participants entered the 5-week single-blind follow-up period and received a daily dose of LX9211 matching placebo tablet, orally.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
1.9%
2/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
15.1%
16/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
27.4%
29/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.9%
2/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.0%
1/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.1%
1/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Nervous system disorders
Headache
|
3.7%
4/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
8.5%
9/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
9.4%
10/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.9%
2/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.0%
1/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
5.7%
6/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
4.7%
5/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
6.6%
7/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.9%
2/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.1%
1/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Gastrointestinal disorders
Nausea
|
2.8%
3/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
8.5%
9/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
11.3%
12/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.96%
1/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
3.3%
3/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Gastrointestinal disorders
Constipation
|
2.8%
3/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
3.8%
4/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
7.5%
8/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
2/107 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
1.9%
2/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
6.6%
7/106 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/104 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
0.00%
0/99 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
2.2%
2/92 • First dose of study drug after randomization up to the end of study (up to Week 11)
The safety population included those participants who took at least 1 dose of study drug during the double-blind treatment period. Adverse events reported occurred at a frequency \>=5% in any treatment group. AEs were collected and reported for treatment period and safety follow up period separately.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution must provide any proposed publication or presentation to Sponsor for Sponsor's review, comment and approval at least thirty (30) days prior to the proposed submission for publication date or the proposed presentation date. Sponsor shall have the right to have deleted from the final version of the publication any confidential information, proprietary information, or patentable participant matter.
- Publication restrictions are in place
Restriction type: OTHER