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

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

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 Disease	Intervention/Treatment	Phase
Cachexia	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

Arm	Intervention/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/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:

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

	Site	City	State	Country	Postal Code
1	Waterbury Pulmonary Associates	Waterbury	Connecticut	United States	06708
2	Clinical Research of West Florida	Clearwater	Florida	United States	33765
3	Innovative Research of West Florida	Largo	Florida	United States	33756
4	The Center for Clinical Research, Washington County Hospital	Hagerstown	Maryland	United States	21740
5	Montana Medical Research, Inc.	Missoula	Montana	United States	59808
6	The Asthma & Allergy Center	Papillion	Nebraska	United States	68046
7	Health Science Research Center - Asthma & Allergy Associates	Cortland	New York	United States	13045
8	New Horizons Clinical Research	Cincinnati	Ohio	United States	45252
9	Clinical Research Institute of Southern Oregon	Medford	Oregon	United States	97504
10	Spartanburg Medical Research	Spartanburg	South Carolina	United States	29303
11	Pulmonary Consultants	Tacoma	Washington	United States	98405
12	Centro de Investigaciones Médicas	Florencío Varela	Buenos Aires	Argentina
13	Instituto de Investigaciones Clinicas Mar del Plata	Mar del Plata	Buenos Aires	Argentina
14	Centro Respiratorio Quilmes	Quilmes	Buenos Aires	Argentina	B1878FNR
15	Instituto de Investigaciones Clínicas Cipolletti	Cipolletti	Río Negro	Argentina	R8324EMD
16	Clinica del Tórax	Rosario	Santa Fe	Argentina	S2000DBS
17	Instituto Cardiovascular de Rosario	Rosario	Santa Fe	Argentina	S2000DSV
18	CEMIT	San Miguel de Tucumán	Tucumán	Argentina
19	Centro de Investigación Médica Lanús	Buenos Aires		Argentina
20	FAICEP	Capital Federal		Argentina	C1122AAK
21	Instituto Médico de Asistencia e Investigación	Capital Federal		Argentina	C1425AWC
22	Centro Médico Dra. De Salvo	Capital Federal		Argentina	C1426ABP
23	Centro Médico Belgrano	Capital Federal		Argentina	C1429BNQ
24	Centro Ceri	Capital Federal		Argentina
25	Centro de Estudios Neumonologicos	Capital Federal		Argentina
26	Fuesmen	Mendoza		Argentina	cp 5500
27	Instituto de Enfermedades Respiratorias	Mendoza		Argentina
28	Centro de Medicina Respiratoria	Paraná		Argentina
29	Instituto de Patologia Respiratoria	Tucuman		Argentina
30	Hospital Barros Luco Trudeau	Santiago		Chile
31	Hospital San Jose	Santiago		Chile
32	Integramedica La Florida	Santiago		Chile
33	Instituto Pneos	Guatemala		Guatemala	01010
34	Edificio Centro Medico II	Guatemala		Guatemala
35	Private Clinic	Guatemala		Guatemala
36	Edificio Medico San Lucas	Quetzaltenango		Guatemala
37	Centro de Neumologia y Alergia	San Pedro Sula		Honduras
38	Instituto Nacional Cardiopulmonar	Tegucigalpa		Honduras
39	Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca	Cluj-Napoca	Cluj	Romania	400371
40	Spitalul Clinic de Boli Infectioase si Pneumoftiziologoe "Dr. Victor Babes"	Timişoara	Timiş	Romania	300310
41	Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca	Cluj-Napoca		Romania	400371
42	Spitalul Clinic de Pneumoftiziologie Constanta, Cartier Palazul Mare	Constanţa		Romania	900002
43	Spitalul Clinic Judetean Sibiu, Clinica Medicala	Sibiu		Romania	550245

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:

• Related Info

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.: Cachexia, COPD, Chronic Obstructive Pulmonary Disease
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Wasting Syndrome; Cachexia

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	Spirometry was performed on participants during screening to define the pulmonary function of each participating subject enrolled in this study.

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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
STARTED	76	75	76
COMPLETED	67	60	65
NOT COMPLETED	9	15	11

Baseline Characteristics

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg	Total
Arm/Group Description	Participants 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 Participants	73	75	76	224
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

Title	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)
Description	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.

Outcome Measure Data

Analysis Population Description

Distance walked during the 6 Minute Walk Test was assessed using the Intent-to-Treat population.

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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 Participants	72	73	69
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

Title	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)
Description	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.

Outcome Measure Data

Analysis Population Description

Distance walked during the 6 Minute Walk Test was assessed using the Intent-to-Treat population.

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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 Participants	72	73	69
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

Title	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)
Description	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.

Outcome Measure Data

Analysis Population Description

Distance walked during the 6 Minute Walk Test was assessed using the Intent-to-Treat population.

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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 Participants	72	73	69
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

Title	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
Description	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.

Outcome Measure Data

Analysis Population Description

The number of participants with improved walking distance was assessed using the Intent-to-Treat population.

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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 Participants	72	73	69
≥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

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

Outcome Measure Data

Analysis Population Description

Mean change in body weight was assessed using the Intent-to-Treat population.

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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 Participants	72	73	69
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

Title	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
Description	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.

Outcome Measure Data

Analysis Population Description

Mean change in lean body mass was assessed using the Intent-to-Treat population.

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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 Participants	72	73	69
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

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

Outcome Measure Data

Analysis Population Description

Absolute concentrations of SUN11031 were assessed using the pharmacokinetic population.

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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 Participants	73	74	76
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

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

Outcome Measure Data

Analysis Population Description

Absolute concentrations of SUN11031 metabolites were assessed using the pharmacokinetic population.

Arm/Group Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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 Participants	73	74	76
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

Title	Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
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.
Time Frame	Baseline 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 Title	Placebo	SUN11031 20 μg/kg	SUN11031 40 μg/kg
Arm/Group Description	Participants 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 Participants	73	75	76
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 Frame	Adverse 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 Title	Placebo		SUN11031 20 μg/kg		SUN11031 40 μg/kg
Arm/Group Description	Participants 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
	Placebo		SUN11031 20 μg/kg		SUN11031 40 μg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/73 (1.4%)		0/75 (0%)		2/76 (2.6%)
Serious Adverse Events
	Placebo		SUN11031 20 μg/kg		SUN11031 40 μg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/73 (8.2%)		6/75 (8%)		8/76 (10.5%)
Cardiac disorders
Acute myocardial infarction	0/73 (0%)		1/75 (1.3%)		0/76 (0%)
Atrial fibrillation	0/73 (0%)		1/75 (1.3%)		0/76 (0%)
Gastrointestinal disorders
Intestinal perforation	1/73 (1.4%)		0/75 (0%)		0/76 (0%)
Small intestinal perforation	0/73 (0%)		1/75 (1.3%)		0/76 (0%)
Gastritis	0/73 (0%)		0/75 (0%)		1/76 (1.3%)
General disorders
Chest pain	0/73 (0%)		0/75 (0%)		1/76 (1.3%)
Hepatobiliary disorders
Cholecystitis	0/73 (0%)		0/75 (0%)		1/76 (1.3%)
Infections and infestations
Pneumonia	1/73 (1.4%)		0/75 (0%)		1/76 (1.3%)
Investigations
Electrocardiogram QT prolonged	1/73 (1.4%)		0/75 (0%)		0/76 (0%)
Nervous system disorders
Senile dementia	0/73 (0%)		0/75 (0%)		1/76 (1.3%)
Psychiatric disorders
Suicidal ideation	0/73 (0%)		0/75 (0%)		1/76 (1.3%)
Completed suicide	0/73 (0%)		0/75 (0%)		1/76 (1.3%)
Renal and urinary disorders
Renal Failure Acute	1/73 (1.4%)		0/75 (0%)		0/76 (0%)
Respiratory, thoracic and mediastinal disorders
COPD	2/73 (2.7%)		3/75 (4%)		1/76 (1.3%)
Pneumothorax	0/73 (0%)		1/75 (1.3%)		0/76 (0%)
Vascular disorders
Hypotension	1/73 (1.4%)		0/75 (0%)		0/76 (0%)
Hypertensive crisis	0/73 (0%)		0/75 (0%)		1/76 (1.3%)
Other (Not Including Serious) Adverse Events
	Placebo		SUN11031 20 μg/kg		SUN11031 40 μg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/73 (74%)		54/75 (72%)		47/76 (61.8%)
Gastrointestinal disorders
Diarrhea	7/73 (9.6%)		2/75 (2.7%)		1/76 (1.3%)
Nausea	3/73 (4.1%)		1/75 (1.3%)		5/76 (6.6%)
Abdominal pain upper	0/73 (0%)		4/75 (5.3%)		3/76 (3.9%)
General disorders
Injection site pain	2/73 (2.7%)		4/75 (5.3%)		2/76 (2.6%)
Infections and infestations
Bronchitis	4/73 (5.5%)		5/75 (6.7%)		3/76 (3.9%)
Nasopharyngitis	1/73 (1.4%)		6/75 (8%)		2/76 (2.6%)
Injury, poisoning and procedural complications
Injection site hematoma	7/73 (9.6%)		3/75 (4%)		7/76 (9.2%)
Investigations
Weight decreased	3/73 (4.1%)		6/75 (8%)		4/76 (5.3%)
Musculoskeletal and connective tissue disorders
Back pain	1/73 (1.4%)		4/75 (5.3%)		3/76 (3.9%)
Nervous system disorders
Headache	5/73 (6.8%)		4/75 (5.3%)		5/76 (6.6%)
Psychiatric disorders
Insomnia	1/73 (1.4%)		0/75 (0%)		4/76 (5.3%)
Respiratory, thoracic and mediastinal disorders
COPD	23/73 (31.5%)		20/75 (26.7%)		16/76 (21.1%)
Skin and subcutaneous tissue disorders
Hyperhidrosis	0/73 (0%)		2/75 (2.7%)		4/76 (5.3%)
Vascular disorders
Hypertension	4/73 (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.