SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00698828
Collaborator
(none)
227
Enrollment
43
Locations
3
Arms
16.8
Actual Duration (Months)
5.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Placebo comparator
  • Drug: SUN11031 20 μg/kg
  • Drug: SUN11031 40 μg/kg
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
227 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2b, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SUN11031 for Injection Administered Subcutaneously Twice Daily for 12 Weeks to Subjects Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
Actual Study Start Date :
May 15, 2008
Actual Primary Completion Date :
Oct 8, 2009
Actual Study Completion Date :
Oct 8, 2009

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group 1

SUN11031 for injection, low dose, twice daily for 12 weeks

Drug: SUN11031 20 μg/kg
Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks.

Experimental: Group 2

SUN11031 for injection, higher dose, twice daily for 12 weeks

Drug: SUN11031 40 μg/kg
Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.

Placebo Comparator: Group 3

Placebo injection, twice daily for 12 weeks

Drug: Placebo comparator
Twice daily subcutaneous injections of placebo for 12 weeks.

Outcome Measures

Primary Outcome Measures

  1. 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) [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 encountered at select sites.

Secondary Outcome Measures

  1. 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) [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 encountered at select sites.

  2. 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) [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 encountered at select sites.

  3. 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 Disease [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 encountered at select sites.

  4. Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease [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.

  5. 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 Disease [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).

  6. Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease [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.

  7. Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease [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.

  8. Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Each participant had to meet the following criteria to be enrolled in the study:
  1. Male or non-pregnant female participants 50 years or older with a clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for greater than or equal to 12 months

  2. Walked a distance of greater than or equal to 100 but less than or equal to 450 meters during the 6-Minute Walk Test (MWT) performed at screening.

  3. Chest x-ray within the past year that was compatible with COPD

  4. Documented involuntary nonedematous weight loss of greater than 5% of participant's usual body weight over the past 12 months or BMI less than or equal to 21 kg/m2 for males or Body Mass Index (BMI) less than or equal to 20 kg/m2 for females

  5. Female participants who were clinically sterile (eg, either postmenopausal or had undergone a tubal ligation or hysterectomy) or were practicing a medically acceptable method of birth control (eg, oral, transdermal, implantable, or injectable contraceptive medications; double-barrier method or intrauterine device)

Exclusion Criteria:
Participants who met any of the following criteria were excluded from the study:
  1. BMI greater than 26 kg/m^2

  2. Used, over a total of 7 or more days, parenteral corticosteroids at a dose equivalent to prednisone at greater than or equal to 5 mg/day or oral corticosteroids at a dose equivalent to prednisone at greater than 10 mg/day within the 2 months before screening; however, participants were allowed to participate if on stable doses equivalent to prednisone at less than or equal to 10 mg/day for at least 2 months before screening, and were planning to remain on the same stable dose throughout the study

  3. Were planning to start a pulmonary rehabilitation program during the study (participant may have been enrolled in the study if he or she was currently on a stable maintenance program)

  4. Weight loss that was considered to be, in the opinion of the investigator, the result of food deprivation

  5. Unintended weight loss that may have been due to disease other than COPD

  6. Unable or unwilling to be trained to self-administer the study drug by subcutaneous injection bid, and for whom arrangements could not be made for a third party to reliably administer the injections

  7. Severe anemia (hemoglobin less than or equal to 8 g/dL)

  8. COPD exacerbation defined as a Type 1 or 2 exacerbation according to the Winnipeg criteria, acute infection, or prolonged fever within 4 weeks before screening

  9. Undergoing treatment or evaluation for cancer, or had a history of treatment for cancer within the past 3 years, exception being nonmelanoma skin cancer (basal cell or squamous cell carcinoma of the skin) and carcinoma in situ of the cervix

  10. Type I or type II diabetes mellitus or a fasting serum glucose of greater than or equal to 115 mg/dL (6.4 mmol/L) (fasting was overnight)

  11. Serious disease or conditions that would have interfered with the participant's ability to complete the functional measures included in this protocol; or any illness that, in the opinion of the investigator, might have interfered with the results of the study or the participant's ability to participate

  12. Pulmonary embolism, deep venous thrombosis, or clinically significant primary pulmonary hypertension within the past 6 months

  13. Significant ischemic heart disease or chronic heart failure (New York Heart Association Class IV cardiac disease)

  14. Uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 110 mm Hg)

  15. A history of symptomatic orthostatic hypotension or syncope; or orthostatic hypotension at screening or baseline (Days -6 to -3) (orthostatic hypotension was defined as a decrease in systolic blood pressure by greater than or equal to 20 mm Hg measured after 2 minutes in a standing position compared with the systolic blood pressure measured after 10 minutes in a supine position)

  16. Evidence of ascites, pleural effusion, or lower extremity edema

  17. Severe vitamin D deficiency (25-hydroxyvitamin D less than 10 ng/mL)

  18. Known mechanical obstruction of the alimentary tract and/or malabsorption

  19. Dental or swallowing problems that may have had a negative effect on food intake

  20. Serum creatinine greater than 2.5 mg/dL; or alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase greater than 3 times the upper limit of normal, or bilirubin greater than 2.5 mg/dL

  21. A diagnosis of human immunodeficiency virus infection or AIDS

  22. Used any prescription drugs and non-prescription drugs/herbs that cause weight loss or affect appetite and absorption or that may cause nausea; or used appetite-promoting or anabolic medications within 15 days before screening

  23. A history of alcohol or drug abuse that, in the opinion of the investigator, would have interfered with the participant's ability to comply with the dosing schedule and protocol-specified requirements

  24. Hypersensitive to any component of SUN11031, or participated at any time in any study in which SUN11031 was administered

  25. Received an investigational drug or product, or participated in a drug study within 30 days before screening

  26. Non-ambulatory or unwilling to cooperate fully with the investigator or a designee, or unwilling or unable to comply with study requirements, such as all assessments required by the protocol, including completion of measures for functional capacity and pulmonary function, or frequent blood sampling and meal instructions; or unable or unwilling to attend all study visits

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Waterbury Pulmonary AssociatesWaterburyConnecticutUnited States06708
2Clinical Research of West FloridaClearwaterFloridaUnited States33765
3Innovative Research of West FloridaLargoFloridaUnited States33756
4The Center for Clinical Research, Washington County HospitalHagerstownMarylandUnited States21740
5Montana Medical Research, Inc.MissoulaMontanaUnited States59808
6The Asthma & Allergy CenterPapillionNebraskaUnited States68046
7Health Science Research Center - Asthma & Allergy AssociatesCortlandNew YorkUnited States13045
8New Horizons Clinical ResearchCincinnatiOhioUnited States45252
9Clinical Research Institute of Southern OregonMedfordOregonUnited States97504
10Spartanburg Medical ResearchSpartanburgSouth CarolinaUnited States29303
11Pulmonary ConsultantsTacomaWashingtonUnited States98405
12Centro de Investigaciones MédicasFlorencío VarelaBuenos AiresArgentina
13Instituto de Investigaciones Clinicas Mar del PlataMar del PlataBuenos AiresArgentina
14Centro Respiratorio QuilmesQuilmesBuenos AiresArgentinaB1878FNR
15Instituto de Investigaciones Clínicas CipollettiCipollettiRío NegroArgentinaR8324EMD
16Clinica del TóraxRosarioSanta FeArgentinaS2000DBS
17Instituto Cardiovascular de RosarioRosarioSanta FeArgentinaS2000DSV
18CEMITSan Miguel de TucumánTucumánArgentina
19Centro de Investigación Médica LanúsBuenos AiresArgentina
20FAICEPCapital FederalArgentinaC1122AAK
21Instituto Médico de Asistencia e InvestigaciónCapital FederalArgentinaC1425AWC
22Centro Médico Dra. De SalvoCapital FederalArgentinaC1426ABP
23Centro Médico BelgranoCapital FederalArgentinaC1429BNQ
24Centro CeriCapital FederalArgentina
25Centro de Estudios NeumonologicosCapital FederalArgentina
26FuesmenMendozaArgentinacp 5500
27Instituto de Enfermedades RespiratoriasMendozaArgentina
28Centro de Medicina RespiratoriaParanáArgentina
29Instituto de Patologia RespiratoriaTucumanArgentina
30Hospital Barros Luco TrudeauSantiagoChile
31Hospital San JoseSantiagoChile
32Integramedica La FloridaSantiagoChile
33Instituto PneosGuatemalaGuatemala01010
34Edificio Centro Medico IIGuatemalaGuatemala
35Private ClinicGuatemalaGuatemala
36Edificio Medico San LucasQuetzaltenangoGuatemala
37Centro de Neumologia y AlergiaSan Pedro SulaHonduras
38Instituto Nacional CardiopulmonarTegucigalpaHonduras
39Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-NapocaCluj-NapocaClujRomania400371
40Spitalul Clinic de Boli Infectioase si Pneumoftiziologoe "Dr. Victor Babes"TimişoaraTimişRomania300310
41Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-NapocaCluj-NapocaRomania400371
42Spitalul Clinic de Pneumoftiziologie Constanta, Cartier Palazul MareConstanţaRomania900002
43Spitalul Clinic Judetean Sibiu, Clinica MedicalaSibiuRomania550245

Sponsors and Collaborators

  • Daiichi Sankyo, Inc.

Investigators

  • Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT00698828
Other Study ID Numbers:
  • ASBI 307
First Posted:
Jun 17, 2008
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daiichi Sankyo, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsA total of 227 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 11 clinic sites in the United States of America (USA), 19 in Argentina, 3 in Chile, 4 in Guatemala, 2 in Honduras, and 6 in Romania. Three (3) participants were enrolled but not treated with the study drug. The remaining 224 enrolled participants were teated.
Pre-assignment DetailSpirometry was performed on participants during screening to define the pulmonary function of each participating subject enrolled in this study.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Period Title: Overall Study
STARTED767576
COMPLETED676065
NOT COMPLETED91511

Baseline Characteristics

Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kgTotal
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.Total of all reporting groups
Overall Participants737576224
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
66.0
(8.85)
64.5
(8.03)
66.2
(9.20)
65.6
(8.70)
Sex: Female, Male (Count of Participants)
Female
31
42.5%
24
32%
24
31.6%
79
35.3%
Male
42
57.5%
51
68%
52
68.4%
145
64.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
57
78.1%
63
84%
59
77.6%
179
79.9%
Not Hispanic or Latino
16
21.9%
12
16%
17
22.4%
45
20.1%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
0
0%
1
1.3%
1
1.3%
2
0.9%
White
65
89%
67
89.3%
71
93.4%
203
90.6%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
8
11%
7
9.3%
4
5.3%
19
8.5%

Outcome Measures

1. Primary Outcome
TitleMean 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)
DescriptionAssessment 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 encountered at select sites.
Time FrameBaseline up to Day 85 post dose.

Outcome Measure Data

Analysis Population Description
Distance walked during the 6 Minute Walk Test was assessed using the Intent-to-Treat population.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Measure Participants727369
Baseline
317.30
(80.62)
333.93
(78.91)
333.30
(68.20)
Change at Day 85
28.50
(54.72)
5.85
(53.38)
10.04
(62.16)
2. Secondary Outcome
TitleMean 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)
DescriptionAssessment 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 encountered at select sites.
Time FrameBaseline up to Day 29, Day 57, and Day 85 post dose.

Outcome Measure Data

Analysis Population Description
Distance walked during the 6 Minute Walk Test was assessed using the Intent-to-Treat population.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Measure Participants727369
Baseline
317.30
(80.62)
333.93
(78.91)
333.30
(68.20)
Change at Day 29
24.26
(56.41)
2.80
(46.45)
15.40
(44.39)
Change at Day 57
27.80
(50.46)
9.66
(47.80)
17.46
(48.27)
Change at Day 85
28.50
(54.72)
5.85
(53.38)
10.04
(62.16)
3. Secondary Outcome
TitleMean 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)
DescriptionAssessment 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 encountered at select sites.
Time FrameBaseline up to Day 29, Day 57, and Day 85 post dose.

Outcome Measure Data

Analysis Population Description
Distance walked during the 6 Minute Walk Test was assessed using the Intent-to-Treat population.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Measure Participants727369
Males: Baseline
316.07
(78.64)
336.24
(86.36)
337.95
(64.10)
Males: Change at Day 29
30.06
(50.34)
-0.97
(53.57)
11.56
(44.91)
Males: Change at Day 57
30.41
(38.30)
10.08
(54.74)
11.13
(45.14)
Males: Change at Day 85
33.24
(49.15)
4.17
(61.90)
11.05
(46.17)
Females: Baseline
318.94
(84.44)
328.60
(59.58)
322.67
(77.39)
Females: Change at Day 29
16.53
(63.69)
11.55
(21.19)
24.42
(42.91)
Females: Change at Day 57
24.34
(63.63)
8.70
(26.45)
31.94
(53.09)
Females: Change at Day 85
22.23
(61.60)
9.75
(25.06)
7.75
(90.11)
Younger Than 65 years: Baseline
353.89
(78.95)
353.35
(72.62)
353.30
(70.19)
Younger Than 65 years: Change at Day 29
33.30
(73.90)
5.19
(43.01)
28.31
(48.78)
Younger Than 65 years: Change at Day 57
36.50
(60.86)
11.79
(47.78)
24.38
(62.35)
Younger Than 65 years: Change at Day 85
31.29
(66.54)
8.76
(46.19)
9.13
(81.60)
65 Years and older: Baseline
291.17
(71.88)
315.04
(81.14)
317.92
(63.29)
65 Years and older: Change at Day 29
17.87
(39.56)
0.47
(50.05)
4.92
(38.00)
65 Years and older: Change at Day 57
21.58
(41.16)
7.59
(48.39)
12.14
(33.71)
65 Years and older: Change at Day 85
26.51
(45.22)
3.02
(60.08)
10.75
(42.79)
Body Mass Index (BMI) <18.9 kg/m^2: Baseline
313.28
(83.74)
322.42
(85.37)
328.58
(74.00)
Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 29
15.78
(45.55)
6.46
(41.74)
16.31
(54.65)
Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 57
17.06
(51.79)
9.67
(47.08)
12.37
(54.52)
Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 85
14.51
(55.14)
5.21
(54.06)
24.99
(48.12)
Body Mass Index (BMI) ≥18.9 kg/m^2: Baseline
322.33
(77.56)
345.14
(71.47)
336.34
(64.94)
Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 29
34.93
(66.93)
-0.76
(50.94)
14.81
(37.21)
Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 57
41.22
(46.08)
9.65
(49.15)
20.74
(44.18)
Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 85
45.99
(49.65)
6.47
(53.47)
0.44
(68.54)
Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Baseline
296.61
(82.27)
315.35
(89.66)
320.20
(75.06)
Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Cange at Day 29
28.65
(48.12)
-8.20
(52.10)
16.31
(39.96)
Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 57
27.67
(49.80)
1.94
(54.31)
15.52
(47.63)
Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 85
20.87
(51.34)
-6.17
(58.31)
2.23
(80.61)
Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Baseline
340.43
(73.14)
356.46
(57.08)
342.25
(62.47)
Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 29
19.61
(64.46)
16.13
(34.82)
14.82
(47.47)
Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 57
27.93
(51.94)
19.02
(37.19)
18.79
(49.25)
Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 85
37.02
(57.85)
20.42
(43.24)
15.38
(45.94)
4. Secondary Outcome
TitleNumber 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 Disease
DescriptionAssessment 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 encountered at select sites.
Time FrameBaseline up to Day 85 post dose.

Outcome Measure Data

Analysis Population Description
The number of participants with improved walking distance was assessed using the Intent-to-Treat population.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Measure Participants727369
≥20 meter improvement at Day 85 : Males
21
28.8%
30
40%
22
28.9%
≥20 meter improvement at Day 85 : Females
17
23.3%
6
8%
12
15.8%
≥20 meter improvement at Day 85 : Younger than 65 years
15
20.5%
13
17.3%
15
19.7%
≥20 meter improvement at Day 85 : 65 Years and older
23
31.5%
13
17.3%
19
25%
≥20 meter improvement at Day 85 : BMI <18.9 kg/m^2
17
23.3%
12
16%
18
23.7%
≥20 meter improvement at Day 85 : BMI ≥18.9 kg/m^2
21
28.8%
14
18.7%
16
21.1%
≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted
16
21.9%
11
14.7%
14
18.4%
≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted
22
30.1%
15
20%
20
26.3%
≥10 meter improvement at Day 85 : Males
28
38.4%
24
32%
26
34.2%
≥10 meter improvement at Day 85 : Females
22
30.1%
10
13.3%
14
18.4%
≥10 meter improvement at Day 85 : Younger than 65 years
20
27.4%
17
22.7%
19
25%
≥10 meter improvement at Day 85 : 65 Years and older
30
41.1%
17
22.7%
21
27.6%
≥10 meter improvement at Day 85 : BMI <18.9 kg/m^2
24
32.9%
16
21.3%
19
25%
≥10 meter improvement at Day 85 : BMI ≥18.9 kg/m^2
26
35.6%
18
24%
21
27.6%
≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted
24
32.9%
16
21.3%
15
19.7%
≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted
26
35.6%
18
24%
25
32.9%
5. Secondary Outcome
TitleMean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
DescriptionMeasurements 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.
Time FrameBaseline up to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85, and Day 99 post dose.

Outcome Measure Data

Analysis Population Description
Mean change in body weight was assessed using the Intent-to-Treat population.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Measure Participants727369
Baseline
48.93
(7.89)
50.63
(8.69)
53.16
(8.80)
Change at Day 8
0.31
(0.72)
0.78
(0.77)
1.00
(0.90)
Change at Day 15
0.43
(0.93)
1.09
(1.28)
1.34
(1.12)
Change at Day 22
0.44
(1.14)
1.36
(1.40)
1.68
(1.42)
Change at Day 29
0.53
(1.23)
1.43
(1.56)
1.86
(1.51)
Change at Day 43
0.48
(1.42)
1.62
(1.68)
2.03
(1.63)
Change at Day 57
0.66
(1.47)
1.62
(1.81)
2.15
(1.86)
Change at Day 85
0.90
(1.71)
1.75
(2.27)
2.44
(2.18)
Change at Day 99
0.84
(1.72)
1.38
(2.35)
1.88
(1.96)
6. Secondary Outcome
TitleMean 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 Disease
DescriptionLean body mass was assessed based on whole-body dual-energy x-ray absorptiometry (DXA).
Time FrameBaseline up to Day 29, Day 85, and Day 99 post dose.

Outcome Measure Data

Analysis Population Description
Mean change in lean body mass was assessed using the Intent-to-Treat population.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Measure Participants727369
Baseline
37.85
(6.77)
39.25
(7.75)
40.39
(6.80)
Change at Day 29
0.45
(0.95)
1.12
(1.13)
1.32
(1.01)
Change at Day 85
0.29
(1.06)
1.36
(1.24)
1.44
(1.50)
Change at Day 99
0.22
(1.16)
0.90
(1.27)
0.74
(1.55)
7. Secondary Outcome
TitleAbsolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
DescriptionAbsolute 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.
Time FrameDay 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.

Outcome Measure Data

Analysis Population Description
Absolute concentrations of SUN11031 were assessed using the pharmacokinetic population.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Measure Participants737476
Seq 1: Predose 0 hrs, Day 1
49.09
(41.92)
392.00
(2032.51)
2125.02
(9355.92)
Seq 2: Predose 0 hrs, Day 1
58.93
(94.06)
1083.62
(5600.63)
79.49
(105.07)
Seq 1+2: Predose 0 hrs, Day 1
54.01
(72.46)
727.64
(4147.16)
1014.59
(6354.99)
Seq 1: Predose 0 hrs, Day 85
55.95
(68.44)
46.51
(26.006)
1090.10
(5491.94)
Seq 2: Predose 0 hrs, Day 85
49.37
(52.93)
1493.67
(4939.87)
258.34
(1052.19)
Seq 1+2: Predose 0 hrs, Day 85
52.72
(60.88)
729.14
(3434.37)
660.36
(3879.76)
Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57
42.51
(37.29)
10967.36
(8543.58)
22717.98
(16899.70)
Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57
278.61
(1278.26)
16094.13
(12895.48)
23107.50
(17012.10)
Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57
155.11
(883.60)
13382.32
(10834.41)
22918.34
(16823.84)
Seq 2: Postdose 0.5 Hrs, Day 85
415.01
(1990.46)
9508.98
(6547.42)
26420.12
(16539.03)
Seq 1+2: Postdose 0.5 Hrs, Day 85
415.01
(1990.46)
9508.98
(6547.42)
26420.12
(16539.03)
Seq 1: Postdose 1 Hr, Day 1
483.03
(2593.24)
4761.62
(5209.23)
14623.63
(13535.30)
Seq 1+2: Postdose 1 Hr, Day 1
483.03
(2593.24)
4761.62
(5209.23)
14623.63
(13535.30)
Seq 2: Postdose 1.5 Hrs, Day 29
27.28
(24.42)
3086.34
(4433.97)
6337.84
(5955.82)
Seq 1+2: Postdose 1.5 Hrs, Day 29
27.28
(24.42)
3086.34
(4433.97)
6337.84
(5955.82)
Seq 1: Postdose 3 Hrs, Day 85
43.80
(72.69)
1137.22
(3218.04)
2415.05
(5479.82)
Seq 1+2: Postdose 3 Hrs, Day 85
43.80
(72.69)
1137.22
(3218.04)
2415.05
(5479.83)
Seq 2: Postdose 4 Hrs, Day 1
52.99
(64.23)
1156.16
(2859.47)
473.67
(1038.69)
Seq 1+2: Postdose 4 Hrs, Day 1
52.99
(64.23)
1156.16
(2859.47)
473.67
(1038.69)
Seq 1: Postdose 6 Hrs, Day 57
51.39
(71.32)
304.67
(1157.61)
431.94
(1282.37)
Seq 1+2: Postdose 6 Hrs, Day 57
51.39
(71.32)
304.67
(1157.61)
431.94
(1282.37)
8. Secondary Outcome
TitleAbsolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
DescriptionAbsolute 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.
Time FrameDay 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.

Outcome Measure Data

Analysis Population Description
Absolute concentrations of SUN11031 metabolites were assessed using the pharmacokinetic population.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Measure Participants737476
Seq 1: Predose 0 hrs, Day 1
189.79
(170.09)
351.53
(1102.43)
547.12
(1276.89)
Seq 2: Predose 0 hrs, Day 1
175.88
(135.75)
754.23
(3103.32)
234.63
(225.77)
Seq 1+2: Predose 0 hrs, Day 1
183.03
(153.42)
541.04
(2265.36)
371.94
(868.91)
Seq 1: Predose 0 hrs, Day 85
207.81
(227.93)
196.17
(131.67)
951.98
(3846.40)
Seq 2: Predose 0 hrs, Day 85
158.60
(131.94)
459.03
(1059.43)
824.12
(3095.66)
Seq 1+2: Predose 0 hrs, Day 85
184.03
(187.86)
317.86
(731.38)
886.97
(3455.15)
Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57
174.87
(186.0)
5401.49
(4793.51)
8680.49
(7747.93)
Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57
292.21
(655.71)
6560.23
(4751.75)
9519.43
(8835.18)
Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57
233.54
(481.75)
5884.30
(4770.54)
9106.62
(8261.72)
Seq 2: Postdose 0.5 Hrs, Day 85
417.51
(1407.84)
6200.68
(5045.86)
10819.65
(7950.18)
Seq 1+2: Postdose 0.5 Hrs, Day 85
417.51
(1407.84)
6200.68
(5045.86)
10819.65
(7950.18)
Seq 1: Postdose 1 Hr, Day 1
438.24
(1658.63)
3071.61
(2422.07)
7929.87
(7053.81)
Seq 1+2: Postdose 1 Hr, Day 1
438.24
(1658.63)
3071.61
(2422.07)
7929.87
(7053.81)
Seq 2: Postdose 1.5 Hrs, Day 29
105.15
(77.91)
2230.16
(1920.22)
4944.39
(4285.93)
Seq 1+2: Postdose 1.5 Hrs, Day 29
105.15
(77.91)
2230.16
(1290.22)
4944.39
(4285.93)
Seq 1: Postdose 3 Hrs, Day 85
128.21
(147.42)
2381.54
(4226.73)
2536.51
(1949.44)
Seq 1+2: Postdose 3 Hrs, Day 85
128.21
(147.42)
2381.54
(4226.73)
2536.51
(1949.44)
Seq 2: Postdose 4 Hrs, Day 1
132.97
(126.11)
1071.31
(1124.55)
993.47
(1167.56)
Seq 1+2: Postdose 4 Hrs, Day 1
132.97
(126.11)
1071.31
(1124.55)
993.47
(1167.56)
Seq 1: Postdose 6 Hrs, Day 57
149.58
(166.07)
577.37
(632.84)
914.64
(769.17)
Seq 1+2: Postdose 6 Hrs, Day 57
149.58
(166.07)
577.37
(632.84)
914.64
(769.17)
9. Secondary Outcome
TitleTreatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
DescriptionTreatment-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.
Time FrameBaseline up to Day 113 post dose, up to a total of 134 days.

Outcome Measure Data

Analysis Population Description
Treatment-emergent adverse events were assessed using the safety population.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Measure Participants737576
Number of Participants with at least 1 TEAE
58
79.5%
59
78.7%
56
73.7%
COPD
23
31.5%
20
26.7%
16
21.1%
Dyspnea
1
1.4%
2
2.7%
3
3.9%
Bronchitis
4
5.5%
5
6.7%
3
3.9%
Nasopharyngitis
1
1.4%
6
8%
2
2.6%
Influenza
2
2.7%
3
4%
3
3.9%
Pneumonia
1
1.4%
2
2.7%
3
3.9%
Gastroenteritis
2
2.7%
2
2.7%
2
2.6%
Urinary tract infection
2
2.7%
1
1.3%
3
3.9%
upper respiratory tract infection
3
4.1%
1
1.3%
2
2.6%
Pharyngitis
1
1.4%
0
0%
2
2.6%
Sinusitis
2
2.7%
1
1.3%
0
0%
Tonsillitis
2
2.7%
1
1.3%
0
0%
Oral herpes
2
2.7%
0
0%
0
0%
Diarrhea
7
9.6%
2
2.7%
1
1.3%
Nausea
3
4.1%
1
1.3%
5
6.6%
Abdominal pain upper
0
0%
4
5.3%
3
3.9%
Toothache
2
2.7%
0
0%
2
2.6%
Abdominal pain
1
1.4%
2
2.7%
0
0%
Dry mouth
1
1.4%
0
0%
2
2.6%
Vomiting
2
2.7%
0
0%
1
1.3%
Injection site hematoma
7
9.6%
3
4%
7
9.2%
Injection site pain
2
2.7%
4
5.3%
2
2.6%
Chest pain
1
1.4%
2
2.7%
1
1.3%
Asthenia
3
4.1%
0
0%
1
1.3%
Thirst
0
0%
0
0%
2
2.6%
Back pain
1
1.4%
4
5.3%
3
3.9%
Arthralgia
1
1.4%
1
1.3%
2
2.6%
Myalgia
2
2.7%
2
2.7%
0
0%
Muscle spasms
0
0%
1
1.3%
2
2.6%
Hepatic enzyme increased
1
1.4%
2
2.7%
0
0%
Weight decreased
3
4.1%
6
8%
4
5.3%
Electrocardiogram QT prolonged
2
2.7%
0
0%
1
1.3%
Headache
5
6.8%
4
5.3%
5
6.6%
Dizziness
1
1.4%
2
2.7%
3
3.9%
Hypertension
4
5.5%
1
1.3%
1
1.3%
Hypotension
2
2.7%
1
1.3%
1
1.3%
Orthostatic hypotension
0
0%
2
2.7%
0
0%
Sinus tachycardia
0
0%
2
2.7%
0
0%
Hyperglycemia
2
2.7%
2
2.7%
1
1.3%
Hyperkalemia
1
1.4%
2
2.7%
0
0%
Insomnia
1
1.4%
0
0%
4
5.3%
Somnolence
2
2.7%
0
0%
1
1.3%
Depression
0
0%
0
0%
2
2.6%
Hyperhidrosis
0
0%
2
2.7%
4
5.3%
Contusion
0
0%
0
0%
2
2.6%
Cholecystitis
0
0%
0
0%
2
2.6%

Adverse Events

Time FrameAdverse event data were collected from baseline up to Day 113 post dose, up to a total of 134 days.
Adverse Event Reporting Description 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.
Arm/Group TitlePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Arm/Group DescriptionParticipants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
All Cause Mortality
PlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/73 (1.4%) 0/75 (0%) 2/76 (2.6%)
Serious Adverse Events
PlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total6/73 (8.2%) 6/75 (8%) 8/76 (10.5%)
Cardiac disorders
Acute myocardial infarction0/73 (0%) 1/75 (1.3%) 0/76 (0%)
Atrial fibrillation0/73 (0%) 1/75 (1.3%) 0/76 (0%)
Gastrointestinal disorders
Intestinal perforation1/73 (1.4%) 0/75 (0%) 0/76 (0%)
Small intestinal perforation0/73 (0%) 1/75 (1.3%) 0/76 (0%)
Gastritis0/73 (0%) 0/75 (0%) 1/76 (1.3%)
General disorders
Chest pain0/73 (0%) 0/75 (0%) 1/76 (1.3%)
Hepatobiliary disorders
Cholecystitis0/73 (0%) 0/75 (0%) 1/76 (1.3%)
Infections and infestations
Pneumonia1/73 (1.4%) 0/75 (0%) 1/76 (1.3%)
Investigations
Electrocardiogram QT prolonged1/73 (1.4%) 0/75 (0%) 0/76 (0%)
Nervous system disorders
Senile dementia0/73 (0%) 0/75 (0%) 1/76 (1.3%)
Psychiatric disorders
Suicidal ideation0/73 (0%) 0/75 (0%) 1/76 (1.3%)
Completed suicide0/73 (0%) 0/75 (0%) 1/76 (1.3%)
Renal and urinary disorders
Renal Failure Acute1/73 (1.4%) 0/75 (0%) 0/76 (0%)
Respiratory, thoracic and mediastinal disorders
COPD2/73 (2.7%) 3/75 (4%) 1/76 (1.3%)
Pneumothorax0/73 (0%) 1/75 (1.3%) 0/76 (0%)
Vascular disorders
Hypotension1/73 (1.4%) 0/75 (0%) 0/76 (0%)
Hypertensive crisis0/73 (0%) 0/75 (0%) 1/76 (1.3%)
Other (Not Including Serious) Adverse Events
PlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total54/73 (74%) 54/75 (72%) 47/76 (61.8%)
Gastrointestinal disorders
Diarrhea7/73 (9.6%) 2/75 (2.7%) 1/76 (1.3%)
Nausea3/73 (4.1%) 1/75 (1.3%) 5/76 (6.6%)
Abdominal pain upper0/73 (0%) 4/75 (5.3%) 3/76 (3.9%)
General disorders
Injection site pain2/73 (2.7%) 4/75 (5.3%) 2/76 (2.6%)
Infections and infestations
Bronchitis4/73 (5.5%) 5/75 (6.7%) 3/76 (3.9%)
Nasopharyngitis1/73 (1.4%) 6/75 (8%) 2/76 (2.6%)
Injury, poisoning and procedural complications
Injection site hematoma7/73 (9.6%) 3/75 (4%) 7/76 (9.2%)
Investigations
Weight decreased3/73 (4.1%) 6/75 (8%) 4/76 (5.3%)
Musculoskeletal and connective tissue disorders
Back pain1/73 (1.4%) 4/75 (5.3%) 3/76 (3.9%)
Nervous system disorders
Headache5/73 (6.8%) 4/75 (5.3%) 5/76 (6.6%)
Psychiatric disorders
Insomnia1/73 (1.4%) 0/75 (0%) 4/76 (5.3%)
Respiratory, thoracic and mediastinal disorders
COPD23/73 (31.5%) 20/75 (26.7%) 16/76 (21.1%)
Skin and subcutaneous tissue disorders
Hyperhidrosis0/73 (0%) 2/75 (2.7%) 4/76 (5.3%)
Vascular disorders
Hypertension4/73 (5.5%) 1/75 (1.3%) 1/76 (1.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleContact for Clinical Trial Information
OrganizationDaiichi Sankyo
Phone908-992-6400
EmailCTRinfo@dsi.com
Responsible Party:
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT00698828
Other Study ID Numbers:
  • ASBI 307
First Posted:
Jun 17, 2008
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021