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CompletedNCT00698828Updated Jan 28, 2021Results posted

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

A Phase 2 interventional study of Placebo comparator and SUN11031 20 μg/kg in Cachexia, sponsored by Daiichi Sankyo. Completed at 43 sites in 6 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Daiichi Sankyo · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
227
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cachexia

Keywords

  • Cachexia, COPD, Chronic Obstructive Pulmonary Disease
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 227 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Daiichi Sankyo is the lead sponsor of 316 studies on the registry; 35 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
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/m\^2 for males or Body Mass Index (BMI) less than or equal to 20 kg/m\^2 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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
227 participants (actual)

Study arms

  • Experimental
    Group 1

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

    Drug: SUN11031 20 μg/kg

  • Experimental
    Group 2

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

    Drug: SUN11031 40 μg/kg

  • Placebo comparator
    Group 3

    Placebo injection, twice daily for 12 weeks

    Drug: Placebo comparator

Interventions

  • DrugPlacebo comparator

    Twice daily subcutaneous injections of placebo for 12 weeks.

  • DrugSUN11031 20 μg/kg

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

  • DrugSUN11031 40 μg/kg

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

06

What researchers measure

Primary outcomes

  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)

    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.

    Time frame: Baseline up to Day 85 post dose.

Secondary outcomes

  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)

    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.

    Time frame: Baseline up to Day 29, Day 57, and Day 85 post dose.

  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)

    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.

    Time frame: Baseline up to Day 29, Day 57, and Day 85 post dose.

  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

    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.

    Time frame: Baseline up to Day 85 post dose.

  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

    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.

    Time frame: Baseline up to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85, and Day 99 post dose.

  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

    Lean body mass was assessed based on whole-body dual-energy x-ray absorptiometry (DXA).

    Time frame: Baseline up to Day 29, Day 85, and Day 99 post dose.

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

    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.

    Time frame: 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.

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

    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.

    Time frame: 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.

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

    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.

    Time frame: Baseline up to Day 113 post dose, up to a total of 134 days.

07

Results

Posted Jan 28, 2021

Participant flow

A 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.

Participant flow — Overall Study
MilestonePlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Started767576
Completed676065
Not completed91511
Withdrew: Adverse event344
Withdrew: Death001
Withdrew: Exacerbation of copd130
Withdrew: Exacerbation of copd (not treated)100
Withdrew: Investigator/sponsor decision102
Withdrew: Lost to follow-up110
Withdrew: Withdrew consent074
Withdrew: Withdrew consent (not treated)200

Outcome measures

PrimaryMean 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)

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.

Time frame:
Baseline up to Day 85 post dose.
Reported as:
Mean · meters
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)
metersPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Baseline317.30 ± 80.62333.93 ± 78.91333.30 ± 68.20
Change at Day 8528.50 ± 54.725.85 ± 53.3810.04 ± 62.16
SecondaryMean 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)

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.

Time frame:
Baseline up to Day 29, Day 57, and Day 85 post dose.
Reported as:
Mean · meters
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)
metersPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Baseline317.30 ± 80.62333.93 ± 78.91333.30 ± 68.20
Change at Day 2924.26 ± 56.412.80 ± 46.4515.40 ± 44.39
Change at Day 5727.80 ± 50.469.66 ± 47.8017.46 ± 48.27
Change at Day 8528.50 ± 54.725.85 ± 53.3810.04 ± 62.16
SecondaryMean 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)

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.

Time frame:
Baseline up to Day 29, Day 57, and Day 85 post dose.
Reported as:
Mean · meters
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)
metersPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Males: Baseline316.07 ± 78.64336.24 ± 86.36337.95 ± 64.10
Males: Change at Day 2930.06 ± 50.34-0.97 ± 53.5711.56 ± 44.91
Males: Change at Day 5730.41 ± 38.3010.08 ± 54.7411.13 ± 45.14
Males: Change at Day 8533.24 ± 49.154.17 ± 61.9011.05 ± 46.17
Females: Baseline318.94 ± 84.44328.60 ± 59.58322.67 ± 77.39
Females: Change at Day 2916.53 ± 63.6911.55 ± 21.1924.42 ± 42.91
Females: Change at Day 5724.34 ± 63.638.70 ± 26.4531.94 ± 53.09
Females: Change at Day 8522.23 ± 61.609.75 ± 25.067.75 ± 90.11
Younger Than 65 years: Baseline353.89 ± 78.95353.35 ± 72.62353.30 ± 70.19
Younger Than 65 years: Change at Day 2933.30 ± 73.905.19 ± 43.0128.31 ± 48.78
Younger Than 65 years: Change at Day 5736.50 ± 60.8611.79 ± 47.7824.38 ± 62.35
Younger Than 65 years: Change at Day 8531.29 ± 66.548.76 ± 46.199.13 ± 81.60
65 Years and older: Baseline291.17 ± 71.88315.04 ± 81.14317.92 ± 63.29
65 Years and older: Change at Day 2917.87 ± 39.560.47 ± 50.054.92 ± 38.00
65 Years and older: Change at Day 5721.58 ± 41.167.59 ± 48.3912.14 ± 33.71
65 Years and older: Change at Day 8526.51 ± 45.223.02 ± 60.0810.75 ± 42.79
Body Mass Index (BMI) <18.9 kg/m^2: Baseline313.28 ± 83.74322.42 ± 85.37328.58 ± 74.00
Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 2915.78 ± 45.556.46 ± 41.7416.31 ± 54.65
Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 5717.06 ± 51.799.67 ± 47.0812.37 ± 54.52
Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 8514.51 ± 55.145.21 ± 54.0624.99 ± 48.12
Body Mass Index (BMI) ≥18.9 kg/m^2: Baseline322.33 ± 77.56345.14 ± 71.47336.34 ± 64.94
Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 2934.93 ± 66.93-0.76 ± 50.9414.81 ± 37.21
Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 5741.22 ± 46.089.65 ± 49.1520.74 ± 44.18
Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 8545.99 ± 49.656.47 ± 53.470.44 ± 68.54
Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Baseline296.61 ± 82.27315.35 ± 89.66320.20 ± 75.06
Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Cange at Day 2928.65 ± 48.12-8.20 ± 52.1016.31 ± 39.96
Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 5727.67 ± 49.801.94 ± 54.3115.52 ± 47.63
Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 8520.87 ± 51.34-6.17 ± 58.312.23 ± 80.61
Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Baseline340.43 ± 73.14356.46 ± 57.08342.25 ± 62.47
Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 2919.61 ± 64.4616.13 ± 34.8214.82 ± 47.47
Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 5727.93 ± 51.9419.02 ± 37.1918.79 ± 49.25
Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 8537.02 ± 57.8520.42 ± 43.2415.38 ± 45.94
SecondaryNumber 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

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.

Time frame:
Baseline up to Day 85 post dose.
Reported as:
Number · participants
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
participantsPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
≥20 meter improvement at Day 85 : Males213022
≥20 meter improvement at Day 85 : Females17612
≥20 meter improvement at Day 85 : Younger than 65 years151315
≥20 meter improvement at Day 85 : 65 Years and older231319
≥20 meter improvement at Day 85 : BMI <18.9 kg/m^2171218
≥20 meter improvement at Day 85 : BMI ≥18.9 kg/m^2211416
≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted161114
≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted221520
≥10 meter improvement at Day 85 : Males282426
≥10 meter improvement at Day 85 : Females221014
≥10 meter improvement at Day 85 : Younger than 65 years201719
≥10 meter improvement at Day 85 : 65 Years and older301721
≥10 meter improvement at Day 85 : BMI <18.9 kg/m^2241619
≥10 meter improvement at Day 85 : BMI ≥18.9 kg/m^2261821
≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted241615
≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted261825
SecondaryMean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

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.

Time frame:
Baseline up to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85, and Day 99 post dose.
Reported as:
Mean · kg
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
kgPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Baseline48.93 ± 7.8950.63 ± 8.6953.16 ± 8.80
Change at Day 80.31 ± 0.720.78 ± 0.771.00 ± 0.90
Change at Day 150.43 ± 0.931.09 ± 1.281.34 ± 1.12
Change at Day 220.44 ± 1.141.36 ± 1.401.68 ± 1.42
Change at Day 290.53 ± 1.231.43 ± 1.561.86 ± 1.51
Change at Day 430.48 ± 1.421.62 ± 1.682.03 ± 1.63
Change at Day 570.66 ± 1.471.62 ± 1.812.15 ± 1.86
Change at Day 850.90 ± 1.711.75 ± 2.272.44 ± 2.18
Change at Day 990.84 ± 1.721.38 ± 2.351.88 ± 1.96
SecondaryMean 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

Lean body mass was assessed based on whole-body dual-energy x-ray absorptiometry (DXA).

Time frame:
Baseline up to Day 29, Day 85, and Day 99 post dose.
Reported as:
Mean · kg
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
kgPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Baseline37.85 ± 6.7739.25 ± 7.7540.39 ± 6.80
Change at Day 290.45 ± 0.951.12 ± 1.131.32 ± 1.01
Change at Day 850.29 ± 1.061.36 ± 1.241.44 ± 1.50
Change at Day 990.22 ± 1.160.90 ± 1.270.74 ± 1.55
SecondaryAbsolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

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.

Time frame:
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.
Reported as:
Mean · pg/mL
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
pg/mLPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Seq 1: Predose 0 hrs, Day 149.09 ± 41.92392.00 ± 2032.512125.02 ± 9355.92
Seq 2: Predose 0 hrs, Day 158.93 ± 94.061083.62 ± 5600.6379.49 ± 105.07
Seq 1+2: Predose 0 hrs, Day 154.01 ± 72.46727.64 ± 4147.161014.59 ± 6354.99
Seq 1: Predose 0 hrs, Day 8555.95 ± 68.4446.51 ± 26.0061090.10 ± 5491.94
Seq 2: Predose 0 hrs, Day 8549.37 ± 52.931493.67 ± 4939.87258.34 ± 1052.19
Seq 1+2: Predose 0 hrs, Day 8552.72 ± 60.88729.14 ± 3434.37660.36 ± 3879.76
Seq 1: Postdose 0.08 Hrs, Day 29 and Day 5742.51 ± 37.2910967.36 ± 8543.5822717.98 ± 16899.70
Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57278.61 ± 1278.2616094.13 ± 12895.4823107.50 ± 17012.10
Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57155.11 ± 883.6013382.32 ± 10834.4122918.34 ± 16823.84
Seq 2: Postdose 0.5 Hrs, Day 85415.01 ± 1990.469508.98 ± 6547.4226420.12 ± 16539.03
Seq 1+2: Postdose 0.5 Hrs, Day 85415.01 ± 1990.469508.98 ± 6547.4226420.12 ± 16539.03
Seq 1: Postdose 1 Hr, Day 1483.03 ± 2593.244761.62 ± 5209.2314623.63 ± 13535.30
Seq 1+2: Postdose 1 Hr, Day 1483.03 ± 2593.244761.62 ± 5209.2314623.63 ± 13535.30
Seq 2: Postdose 1.5 Hrs, Day 2927.28 ± 24.423086.34 ± 4433.976337.84 ± 5955.82
Seq 1+2: Postdose 1.5 Hrs, Day 2927.28 ± 24.423086.34 ± 4433.976337.84 ± 5955.82
Seq 1: Postdose 3 Hrs, Day 8543.80 ± 72.691137.22 ± 3218.042415.05 ± 5479.82
Seq 1+2: Postdose 3 Hrs, Day 8543.80 ± 72.691137.22 ± 3218.042415.05 ± 5479.83
Seq 2: Postdose 4 Hrs, Day 152.99 ± 64.231156.16 ± 2859.47473.67 ± 1038.69
Seq 1+2: Postdose 4 Hrs, Day 152.99 ± 64.231156.16 ± 2859.47473.67 ± 1038.69
Seq 1: Postdose 6 Hrs, Day 5751.39 ± 71.32304.67 ± 1157.61431.94 ± 1282.37
Seq 1+2: Postdose 6 Hrs, Day 5751.39 ± 71.32304.67 ± 1157.61431.94 ± 1282.37
SecondaryAbsolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

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.

Time frame:
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.
Reported as:
Mean · pg/mL
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
pg/mLPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Seq 1: Predose 0 hrs, Day 1189.79 ± 170.09351.53 ± 1102.43547.12 ± 1276.89
Seq 2: Predose 0 hrs, Day 1175.88 ± 135.75754.23 ± 3103.32234.63 ± 225.77
Seq 1+2: Predose 0 hrs, Day 1183.03 ± 153.42541.04 ± 2265.36371.94 ± 868.91
Seq 1: Predose 0 hrs, Day 85207.81 ± 227.93196.17 ± 131.67951.98 ± 3846.40
Seq 2: Predose 0 hrs, Day 85158.60 ± 131.94459.03 ± 1059.43824.12 ± 3095.66
Seq 1+2: Predose 0 hrs, Day 85184.03 ± 187.86317.86 ± 731.38886.97 ± 3455.15
Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57174.87 ± 186.05401.49 ± 4793.518680.49 ± 7747.93
Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57292.21 ± 655.716560.23 ± 4751.759519.43 ± 8835.18
Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57233.54 ± 481.755884.30 ± 4770.549106.62 ± 8261.72
Seq 2: Postdose 0.5 Hrs, Day 85417.51 ± 1407.846200.68 ± 5045.8610819.65 ± 7950.18
Seq 1+2: Postdose 0.5 Hrs, Day 85417.51 ± 1407.846200.68 ± 5045.8610819.65 ± 7950.18
Seq 1: Postdose 1 Hr, Day 1438.24 ± 1658.633071.61 ± 2422.077929.87 ± 7053.81
Seq 1+2: Postdose 1 Hr, Day 1438.24 ± 1658.633071.61 ± 2422.077929.87 ± 7053.81
Seq 2: Postdose 1.5 Hrs, Day 29105.15 ± 77.912230.16 ± 1920.224944.39 ± 4285.93
Seq 1+2: Postdose 1.5 Hrs, Day 29105.15 ± 77.912230.16 ± 1290.224944.39 ± 4285.93
Seq 1: Postdose 3 Hrs, Day 85128.21 ± 147.422381.54 ± 4226.732536.51 ± 1949.44
Seq 1+2: Postdose 3 Hrs, Day 85128.21 ± 147.422381.54 ± 4226.732536.51 ± 1949.44
Seq 2: Postdose 4 Hrs, Day 1132.97 ± 126.111071.31 ± 1124.55993.47 ± 1167.56
Seq 1+2: Postdose 4 Hrs, Day 1132.97 ± 126.111071.31 ± 1124.55993.47 ± 1167.56
Seq 1: Postdose 6 Hrs, Day 57149.58 ± 166.07577.37 ± 632.84914.64 ± 769.17
Seq 1+2: Postdose 6 Hrs, Day 57149.58 ± 166.07577.37 ± 632.84914.64 ± 769.17
SecondaryTreatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

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.

Time frame:
Baseline up to Day 113 post dose, up to a total of 134 days.
Reported as:
Count of participants · Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
ParticipantsPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
Number of Participants with at least 1 TEAE585956
COPD232016
Dyspnea123
Bronchitis453
Nasopharyngitis162
Influenza233
Pneumonia123
Gastroenteritis222
Urinary tract infection213
upper respiratory tract infection312
Pharyngitis102
Sinusitis210
Tonsillitis210
Oral herpes200
Diarrhea721
Nausea315
Abdominal pain upper043
Toothache202
Abdominal pain120
Dry mouth102
Vomiting201
Injection site hematoma737
Injection site pain242
Chest pain121
Asthenia301
Thirst002
Back pain143
Arthralgia112
Myalgia220
Muscle spasms012
Hepatic enzyme increased120
Weight decreased364
Electrocardiogram QT prolonged201
Headache545
Dizziness123
Hypertension411
Hypotension211
Orthostatic hypotension020
Sinus tachycardia020
Hyperglycemia221
Hyperkalemia120
Insomnia104
Somnolence201
Depression002
Hyperhidrosis024
Contusion002
Cholecystitis002

Adverse events

Collected over Adverse event data were collected from baseline up to Day 113 post dose, up to a total of 134 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo1/73 (1.4%)6/73 (8.2%)54/73 (74%)
SUN11031 20 μg/kg0/75 (0%)6/75 (8%)54/75 (72%)
SUN11031 40 μg/kg2/76 (2.6%)8/76 (10.5%)47/76 (61.8%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
COPDRespiratory, thoracic and mediastinal disorders2/733/751/76
Renal Failure AcuteRenal and urinary disorders1/730/750/76
PneumoniaInfections and infestations1/730/751/76
Intestinal perforationGastrointestinal disorders1/730/750/76
HypotensionVascular disorders1/730/750/76
Electrocardiogram QT prolongedInvestigations1/730/750/76
PneumothoraxRespiratory, thoracic and mediastinal disorders0/731/750/76
Acute myocardial infarctionCardiac disorders0/731/750/76
Atrial fibrillationCardiac disorders0/731/750/76
Small intestinal perforationGastrointestinal disorders0/731/750/76
Most frequent other events
Showing 10 of 14
Most frequent other events
EventPlaceboSUN11031 20 μg/kgSUN11031 40 μg/kg
COPDRespiratory, thoracic and mediastinal disorders23/7320/7516/76
Injection site hematomaInjury, poisoning and procedural complications7/733/757/76
DiarrheaGastrointestinal disorders7/732/751/76
Weight decreasedInvestigations3/736/754/76
NasopharyngitisInfections and infestations1/736/752/76
HeadacheNervous system disorders5/734/755/76
BronchitisInfections and infestations4/735/753/76
NauseaGastrointestinal disorders3/731/755/76
HypertensionVascular disorders4/731/751/76
Back painMusculoskeletal and connective tissue disorders1/734/753/76

Baseline characteristics

Baseline characteristics were assessed using the Safety population.

Age, Continuous
Age, Continuous(years)PlaceboSUN11031 20 μg/kgSUN11031 40 μg/kgTotal
Mean66.0 ± 8.8564.5 ± 8.0366.2 ± 9.2065.6 ± 8.70
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboSUN11031 20 μg/kgSUN11031 40 μg/kgTotal
Female31242479
Male425152145
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboSUN11031 20 μg/kgSUN11031 40 μg/kgTotal
Hispanic or Latino576359179
Not Hispanic or Latino16121745
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboSUN11031 20 μg/kgSUN11031 40 μg/kgTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American0112
White656771203
More than one race0000
Unknown or Not Reported87419
08

Study locations

43 sites
  • Waterbury Pulmonary Associates
    Waterbury, Connecticut 06708, United States
  • Clinical Research of West Florida
    Clearwater, Florida 33765, United States
  • Innovative Research of West Florida
    Largo, Florida 33756, United States
  • The Center for Clinical Research, Washington County Hospital
    Hagerstown, Maryland 21740, United States
  • Montana Medical Research, Inc.
    Missoula, Montana 59808, United States
  • The Asthma & Allergy Center
    Papillion, Nebraska 68046, United States
  • Health Science Research Center - Asthma & Allergy Associates
    Cortland, New York 13045, United States
  • New Horizons Clinical Research
    Cincinnati, Ohio 45252, United States
  • Clinical Research Institute of Southern Oregon
    Medford, Oregon 97504, United States
  • Spartanburg Medical Research
    Spartanburg, South Carolina 29303, United States
  • Pulmonary Consultants
    Tacoma, Washington 98405, United States
  • Centro de Investigaciones Médicas
    Florencío Varela, Buenos Aires, Argentina
  • Instituto de Investigaciones Clinicas Mar del Plata
    Mar del Plata, Buenos Aires, Argentina
  • Centro Respiratorio Quilmes
    Quilmes, Buenos Aires B1878FNR, Argentina
  • Instituto de Investigaciones Clínicas Cipolletti
    Cipolletti, Río Negro R8324EMD, Argentina
  • Clinica del Tórax
    Rosario, Santa Fe S2000DBS, Argentina
  • Instituto Cardiovascular de Rosario
    Rosario, Santa Fe S2000DSV, Argentina
  • CEMIT
    San Miguel de Tucumán, Tucumán, Argentina
  • Centro de Investigación Médica Lanús
    Buenos Aires, Argentina
  • FAICEP
    Capital Federal, C1122AAK, Argentina
  • Instituto Médico de Asistencia e Investigación
    Capital Federal, C1425AWC, Argentina
  • Centro Médico Dra. De Salvo
    Capital Federal, C1426ABP, Argentina
  • Centro Médico Belgrano
    Capital Federal, C1429BNQ, Argentina
  • Centro Ceri
    Capital Federal, Argentina
  • Centro de Estudios Neumonologicos
    Capital Federal, Argentina
  • Fuesmen
    Mendoza, cp 5500, Argentina
  • Instituto de Enfermedades Respiratorias
    Mendoza, Argentina
  • Centro de Medicina Respiratoria
    Paraná, Argentina
  • Instituto de Patologia Respiratoria
    Tucuman, Argentina
  • Hospital Barros Luco Trudeau
    Santiago, Chile
  • Hospital San Jose
    Santiago, Chile
  • Integramedica La Florida
    Santiago, Chile
  • Instituto Pneos
    Guatemala, 01010, Guatemala
  • Edificio Centro Medico II
    Guatemala, Guatemala
  • Private Clinic
    Guatemala, Guatemala
  • Edificio Medico San Lucas
    Quetzaltenango, Guatemala
  • Centro de Neumologia y Alergia
    San Pedro Sula, Honduras
  • Instituto Nacional Cardiopulmonar
    Tegucigalpa, Honduras
  • Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca
    Cluj-Napoca, Cluj 400371, Romania
  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologoe "Dr. Victor Babes"
    Timişoara, Timiş 300310, Romania
  • Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca
    Cluj-Napoca, 400371, Romania
  • Spitalul Clinic de Pneumoftiziologie Constanta, Cartier Palazul Mare
    Constanţa, 900002, Romania
  • Spitalul Clinic Judetean Sibiu, Clinica Medicala
    Sibiu, 550245, Romania
09

References and documents

Related links

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00698828
Lead sponsor
Daiichi Sankyo
Responsible party
Sponsor
First posted
Jun 17, 2008
Start date
May 15, 2008
Primary completion
Oct 8, 2009
Completion
Oct 8, 2009
Results posted
Jan 28, 2021
Last update
Jan 28, 2021

Study contacts

Global Clinical Leader
study director · Daiichi Sankyo

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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