50 and older, any sex, with Cachexia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)Primary· Baseline up to Day 85 post dose.
Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations enc
Baseline
Group
Value
95% CI
Placebo
317.30
± 80.62
SUN11031 20 μg/kg
333.93
± 78.91
SUN11031 40 μg/kg
333.30
± 68.20
Change at Day 85
Group
Value
95% CI
Placebo
28.50
± 54.72
SUN11031 20 μg/kg
5.85
± 53.38
SUN11031 40 μg/kg
10.04
± 62.16
Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)Secondary· Baseline up to Day 29, Day 57, and Day 85 post dose.
Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations enc
Baseline
Group
Value
95% CI
Placebo
317.30
± 80.62
SUN11031 20 μg/kg
333.93
± 78.91
SUN11031 40 μg/kg
333.30
± 68.20
Change at Day 29
Group
Value
95% CI
Placebo
24.26
± 56.41
SUN11031 20 μg/kg
2.80
± 46.45
SUN11031 40 μg/kg
15.40
± 44.39
Change at Day 57
Group
Value
95% CI
Placebo
27.80
± 50.46
SUN11031 20 μg/kg
9.66
± 47.80
SUN11031 40 μg/kg
17.46
± 48.27
Change at Day 85
Group
Value
95% CI
Placebo
28.50
± 54.72
SUN11031 20 μg/kg
5.85
± 53.38
SUN11031 40 μg/kg
10.04
± 62.16
Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)Secondary· Baseline up to Day 29, Day 57, and Day 85 post dose.
Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations enc
Males: Baseline
Group
Value
95% CI
Placebo
316.07
± 78.64
SUN11031 20 μg/kg
336.24
± 86.36
SUN11031 40 μg/kg
337.95
± 64.10
Males: Change at Day 29
Group
Value
95% CI
Placebo
30.06
± 50.34
SUN11031 20 μg/kg
-0.97
± 53.57
SUN11031 40 μg/kg
11.56
± 44.91
Males: Change at Day 57
Group
Value
95% CI
Placebo
30.41
± 38.30
SUN11031 20 μg/kg
10.08
± 54.74
SUN11031 40 μg/kg
11.13
± 45.14
Males: Change at Day 85
Group
Value
95% CI
Placebo
33.24
± 49.15
SUN11031 20 μg/kg
4.17
± 61.90
SUN11031 40 μg/kg
11.05
± 46.17
Females: Baseline
Group
Value
95% CI
Placebo
318.94
± 84.44
SUN11031 20 μg/kg
328.60
± 59.58
SUN11031 40 μg/kg
322.67
± 77.39
Females: Change at Day 29
Group
Value
95% CI
Placebo
16.53
± 63.69
SUN11031 20 μg/kg
11.55
± 21.19
SUN11031 40 μg/kg
24.42
± 42.91
Females: Change at Day 57
Group
Value
95% CI
Placebo
24.34
± 63.63
SUN11031 20 μg/kg
8.70
± 26.45
SUN11031 40 μg/kg
31.94
± 53.09
Females: Change at Day 85
Group
Value
95% CI
Placebo
22.23
± 61.60
SUN11031 20 μg/kg
9.75
± 25.06
SUN11031 40 μg/kg
7.75
± 90.11
Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary DiseaseSecondary· Baseline up to Day 85 post dose.
Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations enc
≥20 meter improvement at Day 85 : Males
Group
Value
95% CI
Placebo
21
SUN11031 20 μg/kg
30
SUN11031 40 μg/kg
22
≥20 meter improvement at Day 85 : Females
Group
Value
95% CI
Placebo
17
SUN11031 20 μg/kg
6
SUN11031 40 μg/kg
12
≥20 meter improvement at Day 85 : Younger than 65 years
Group
Value
95% CI
Placebo
15
SUN11031 20 μg/kg
13
SUN11031 40 μg/kg
15
≥20 meter improvement at Day 85 : 65 Years and older
Group
Value
95% CI
Placebo
23
SUN11031 20 μg/kg
13
SUN11031 40 μg/kg
19
≥20 meter improvement at Day 85 : BMI <18.9 kg/m^2
Group
Value
95% CI
Placebo
17
SUN11031 20 μg/kg
12
SUN11031 40 μg/kg
18
≥20 meter improvement at Day 85 : BMI ≥18.9 kg/m^2
Group
Value
95% CI
Placebo
21
SUN11031 20 μg/kg
14
SUN11031 40 μg/kg
16
≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted
Group
Value
95% CI
Placebo
16
SUN11031 20 μg/kg
11
SUN11031 40 μg/kg
14
≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted
Group
Value
95% CI
Placebo
22
SUN11031 20 μg/kg
15
SUN11031 40 μg/kg
20
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary DiseaseSecondary· Baseline up to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85, and Day 99 post dose.
Measurements of body weight were performed in the morning when the participant had an empty stomach (ie, had consumed no food overnight) and had emptied the bladder and had a bowel movement, if possible. These measurements were performed using the same calibrated scale for an individual participant throughout study.
Baseline
Group
Value
95% CI
Placebo
48.93
± 7.89
SUN11031 20 μg/kg
50.63
± 8.69
SUN11031 40 μg/kg
53.16
± 8.80
Change at Day 8
Group
Value
95% CI
Placebo
0.31
± 0.72
SUN11031 20 μg/kg
0.78
± 0.77
SUN11031 40 μg/kg
1.00
± 0.90
Change at Day 15
Group
Value
95% CI
Placebo
0.43
± 0.93
SUN11031 20 μg/kg
1.09
± 1.28
SUN11031 40 μg/kg
1.34
± 1.12
Change at Day 22
Group
Value
95% CI
Placebo
0.44
± 1.14
SUN11031 20 μg/kg
1.36
± 1.40
SUN11031 40 μg/kg
1.68
± 1.42
Change at Day 29
Group
Value
95% CI
Placebo
0.53
± 1.23
SUN11031 20 μg/kg
1.43
± 1.56
SUN11031 40 μg/kg
1.86
± 1.51
Change at Day 43
Group
Value
95% CI
Placebo
0.48
± 1.42
SUN11031 20 μg/kg
1.62
± 1.68
SUN11031 40 μg/kg
2.03
± 1.63
Change at Day 57
Group
Value
95% CI
Placebo
0.66
± 1.47
SUN11031 20 μg/kg
1.62
± 1.81
SUN11031 40 μg/kg
2.15
± 1.86
Change at Day 85
Group
Value
95% CI
Placebo
0.90
± 1.71
SUN11031 20 μg/kg
1.75
± 2.27
SUN11031 40 μg/kg
2.44
± 2.18
Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary DiseaseSecondary· Baseline up to Day 29, Day 85, and Day 99 post dose.
Lean body mass was assessed based on whole-body dual-energy x-ray absorptiometry (DXA).
Baseline
Group
Value
95% CI
Placebo
37.85
± 6.77
SUN11031 20 μg/kg
39.25
± 7.75
SUN11031 40 μg/kg
40.39
± 6.80
Change at Day 29
Group
Value
95% CI
Placebo
0.45
± 0.95
SUN11031 20 μg/kg
1.12
± 1.13
SUN11031 40 μg/kg
1.32
± 1.01
Change at Day 85
Group
Value
95% CI
Placebo
0.29
± 1.06
SUN11031 20 μg/kg
1.36
± 1.24
SUN11031 40 μg/kg
1.44
± 1.50
Change at Day 99
Group
Value
95% CI
Placebo
0.22
± 1.16
SUN11031 20 μg/kg
0.90
± 1.27
SUN11031 40 μg/kg
0.74
± 1.55
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary DiseaseSecondary· Day 1 and Day 85 pre-dose; Day 1 at 1 hour and 4 hours; Day 29 at 0.08 hours and 1.5 hours; Day 57 at 0.08 hours and 6 hours; Day 85 at 0.5 hours and 3 hours postdose.
Absolute concentrations of SUN11031 in participant plasma samples were measured. When participants were randomly assigned into 1 of 3 treatment groups at baseline, they were also randomly assigned into 1 of 2 sequences in the pharmacokinetic (PK) sparse sampling schedule based on the randomization number.
Seq 1: Predose 0 hrs, Day 1
Group
Value
95% CI
Placebo
49.09
± 41.92
SUN11031 20 μg/kg
392.00
± 2032.51
SUN11031 40 μg/kg
2125.02
± 9355.92
Seq 2: Predose 0 hrs, Day 1
Group
Value
95% CI
Placebo
58.93
± 94.06
SUN11031 20 μg/kg
1083.62
± 5600.63
SUN11031 40 μg/kg
79.49
± 105.07
Seq 1+2: Predose 0 hrs, Day 1
Group
Value
95% CI
Placebo
54.01
± 72.46
SUN11031 20 μg/kg
727.64
± 4147.16
SUN11031 40 μg/kg
1014.59
± 6354.99
Seq 1: Predose 0 hrs, Day 85
Group
Value
95% CI
Placebo
55.95
± 68.44
SUN11031 20 μg/kg
46.51
± 26.006
SUN11031 40 μg/kg
1090.10
± 5491.94
Seq 2: Predose 0 hrs, Day 85
Group
Value
95% CI
Placebo
49.37
± 52.93
SUN11031 20 μg/kg
1493.67
± 4939.87
SUN11031 40 μg/kg
258.34
± 1052.19
Seq 1+2: Predose 0 hrs, Day 85
Group
Value
95% CI
Placebo
52.72
± 60.88
SUN11031 20 μg/kg
729.14
± 3434.37
SUN11031 40 μg/kg
660.36
± 3879.76
Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57
Group
Value
95% CI
Placebo
42.51
± 37.29
SUN11031 20 μg/kg
10967.36
± 8543.58
SUN11031 40 μg/kg
22717.98
± 16899.70
Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57
Group
Value
95% CI
Placebo
278.61
± 1278.26
SUN11031 20 μg/kg
16094.13
± 12895.48
SUN11031 40 μg/kg
23107.50
± 17012.10
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary DiseaseSecondary· Day 1 and Day 85 pre-dose; Day 1 at 1 hour and 4 hours; Day 29 at 0.08 hours and 1.5 hours; Day 57 at 0.08 hours and 6 hours; Day 85 at 0.5 hours and 3 hours postdose.
Absolute concentrations of SUN11031 metabolites desacyl-ghrelin in participant plasma samples were measured. When participants were randomly assigned into 1 of 3 treatment groups at baseline, they were also randomly assigned into 1 of 2 sequences in the pharmacokinetic (PK) sparse sampling schedule based on the randomization number.
Seq 1: Predose 0 hrs, Day 1
Group
Value
95% CI
Placebo
189.79
± 170.09
SUN11031 20 μg/kg
351.53
± 1102.43
SUN11031 40 μg/kg
547.12
± 1276.89
Seq 2: Predose 0 hrs, Day 1
Group
Value
95% CI
Placebo
175.88
± 135.75
SUN11031 20 μg/kg
754.23
± 3103.32
SUN11031 40 μg/kg
234.63
± 225.77
Seq 1+2: Predose 0 hrs, Day 1
Group
Value
95% CI
Placebo
183.03
± 153.42
SUN11031 20 μg/kg
541.04
± 2265.36
SUN11031 40 μg/kg
371.94
± 868.91
Seq 1: Predose 0 hrs, Day 85
Group
Value
95% CI
Placebo
207.81
± 227.93
SUN11031 20 μg/kg
196.17
± 131.67
SUN11031 40 μg/kg
951.98
± 3846.40
Seq 2: Predose 0 hrs, Day 85
Group
Value
95% CI
Placebo
158.60
± 131.94
SUN11031 20 μg/kg
459.03
± 1059.43
SUN11031 40 μg/kg
824.12
± 3095.66
Seq 1+2: Predose 0 hrs, Day 85
Group
Value
95% CI
Placebo
184.03
± 187.86
SUN11031 20 μg/kg
317.86
± 731.38
SUN11031 40 μg/kg
886.97
± 3455.15
Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57
Group
Value
95% CI
Placebo
174.87
± 186.0
SUN11031 20 μg/kg
5401.49
± 4793.51
SUN11031 40 μg/kg
8680.49
± 7747.93
Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57
Group
Value
95% CI
Placebo
292.21
± 655.71
SUN11031 20 μg/kg
6560.23
± 4751.75
SUN11031 40 μg/kg
9519.43
± 8835.18
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary DiseaseSecondary· Baseline up to Day 113 post dose, up to a total of 134 days.
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred from the time treatment was administered at Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Number of Participants with at least 1 TEAE
Group
Value
95% CI
Placebo
58
SUN11031 20 μg/kg
59
SUN11031 40 μg/kg
56
COPD
Group
Value
95% CI
Placebo
23
SUN11031 20 μg/kg
20
SUN11031 40 μg/kg
16
Dyspnea
Group
Value
95% CI
Placebo
1
SUN11031 20 μg/kg
2
SUN11031 40 μg/kg
3
Bronchitis
Group
Value
95% CI
Placebo
4
SUN11031 20 μg/kg
5
SUN11031 40 μg/kg
3
Nasopharyngitis
Group
Value
95% CI
Placebo
1
SUN11031 20 μg/kg
6
SUN11031 40 μg/kg
2
Influenza
Group
Value
95% CI
Placebo
2
SUN11031 20 μg/kg
3
SUN11031 40 μg/kg
3
Pneumonia
Group
Value
95% CI
Placebo
1
SUN11031 20 μg/kg
2
SUN11031 40 μg/kg
3
Gastroenteritis
Group
Value
95% CI
Placebo
2
SUN11031 20 μg/kg
2
SUN11031 40 μg/kg
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from baseline up to Day 113 post dose, up to a total of 134 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical performance and body composition.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Daiichi Sankyo
Last refreshed: 28 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00698828.