Trial Outcomes & Findings for SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00698828)

Last Updated: 2021-01-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

227 participants

Primary outcome timeframe

Baseline up to Day 85 post dose.

Results posted on

2021-01-28

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.

Spirometry was performed on participants during screening to define the pulmonary function of each participating subject enrolled in this study.

Participant milestones

Participant milestones
Measure	Placebo Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Overall Study STARTED	76	75	76
Overall Study COMPLETED	67	60	65
Overall Study NOT COMPLETED	9	15	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Overall Study Adverse Event	3	4	4
Overall Study Death	0	0	1
Overall Study Exacerbation of COPD	1	3	0
Overall Study Exacerbation of COPD (Not treated)	1	0	0
Overall Study Investigator/Sponsor decision	1	0	2
Overall Study Lost to Follow-up	1	1	0
Overall Study Withdrew consent	0	7	4
Overall Study Withdrew consent (not treated)	2	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=75 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=76 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.	Total n=224 Participants Total of all reporting groups
Age, Continuous	66.0 years STANDARD_DEVIATION 8.85 • n=5 Participants	64.5 years STANDARD_DEVIATION 8.03 • n=7 Participants	66.2 years STANDARD_DEVIATION 9.20 • n=5 Participants	65.6 years STANDARD_DEVIATION 8.70 • n=4 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants	79 Participants n=4 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	51 Participants n=7 Participants	52 Participants n=5 Participants	145 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	57 Participants n=5 Participants	63 Participants n=7 Participants	59 Participants n=5 Participants	179 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants	45 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	65 Participants n=5 Participants	67 Participants n=7 Participants	71 Participants n=5 Participants	203 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline up to Day 85 post dose.

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

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=69 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
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	317.30 meters Standard Deviation 80.62	333.93 meters Standard Deviation 78.91	333.30 meters Standard Deviation 68.20
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) Change at Day 85	28.50 meters Standard Deviation 54.72	5.85 meters Standard Deviation 53.38	10.04 meters Standard Deviation 62.16

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=69 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
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	317.30 meters Standard Deviation 80.62	333.93 meters Standard Deviation 78.91	333.30 meters Standard Deviation 68.20
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) Change at Day 29	24.26 meters Standard Deviation 56.41	2.80 meters Standard Deviation 46.45	15.40 meters Standard Deviation 44.39
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) Change at Day 57	27.80 meters Standard Deviation 50.46	9.66 meters Standard Deviation 47.80	17.46 meters Standard Deviation 48.27
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) Change at Day 85	28.50 meters Standard Deviation 54.72	5.85 meters Standard Deviation 53.38	10.04 meters Standard Deviation 62.16

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=69 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
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) Males: Baseline	316.07 meters Standard Deviation 78.64	336.24 meters Standard Deviation 86.36	337.95 meters Standard Deviation 64.10
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) Males: Change at Day 29	30.06 meters Standard Deviation 50.34	-0.97 meters Standard Deviation 53.57	11.56 meters Standard Deviation 44.91
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) Males: Change at Day 57	30.41 meters Standard Deviation 38.30	10.08 meters Standard Deviation 54.74	11.13 meters Standard Deviation 45.14
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) Males: Change at Day 85	33.24 meters Standard Deviation 49.15	4.17 meters Standard Deviation 61.90	11.05 meters Standard Deviation 46.17
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) Females: Baseline	318.94 meters Standard Deviation 84.44	328.60 meters Standard Deviation 59.58	322.67 meters Standard Deviation 77.39
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) Females: Change at Day 29	16.53 meters Standard Deviation 63.69	11.55 meters Standard Deviation 21.19	24.42 meters Standard Deviation 42.91
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) Females: Change at Day 57	24.34 meters Standard Deviation 63.63	8.70 meters Standard Deviation 26.45	31.94 meters Standard Deviation 53.09
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) Females: Change at Day 85	22.23 meters Standard Deviation 61.60	9.75 meters Standard Deviation 25.06	7.75 meters Standard Deviation 90.11
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) Younger Than 65 years: Baseline	353.89 meters Standard Deviation 78.95	353.35 meters Standard Deviation 72.62	353.30 meters Standard Deviation 70.19
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) Younger Than 65 years: Change at Day 29	33.30 meters Standard Deviation 73.90	5.19 meters Standard Deviation 43.01	28.31 meters Standard Deviation 48.78
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) Younger Than 65 years: Change at Day 57	36.50 meters Standard Deviation 60.86	11.79 meters Standard Deviation 47.78	24.38 meters Standard Deviation 62.35
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) Younger Than 65 years: Change at Day 85	31.29 meters Standard Deviation 66.54	8.76 meters Standard Deviation 46.19	9.13 meters Standard Deviation 81.60
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) 65 Years and older: Baseline	291.17 meters Standard Deviation 71.88	315.04 meters Standard Deviation 81.14	317.92 meters Standard Deviation 63.29
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) 65 Years and older: Change at Day 29	17.87 meters Standard Deviation 39.56	0.47 meters Standard Deviation 50.05	4.92 meters Standard Deviation 38.00
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) 65 Years and older: Change at Day 57	21.58 meters Standard Deviation 41.16	7.59 meters Standard Deviation 48.39	12.14 meters Standard Deviation 33.71
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) 65 Years and older: Change at Day 85	26.51 meters Standard Deviation 45.22	3.02 meters Standard Deviation 60.08	10.75 meters Standard Deviation 42.79
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) Body Mass Index (BMI) <18.9 kg/m^2: Baseline	313.28 meters Standard Deviation 83.74	322.42 meters Standard Deviation 85.37	328.58 meters Standard Deviation 74.00
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) Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 29	15.78 meters Standard Deviation 45.55	6.46 meters Standard Deviation 41.74	16.31 meters Standard Deviation 54.65
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) Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 57	17.06 meters Standard Deviation 51.79	9.67 meters Standard Deviation 47.08	12.37 meters Standard Deviation 54.52
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) Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 85	14.51 meters Standard Deviation 55.14	5.21 meters Standard Deviation 54.06	24.99 meters Standard Deviation 48.12
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) Body Mass Index (BMI) ≥18.9 kg/m^2: Baseline	322.33 meters Standard Deviation 77.56	345.14 meters Standard Deviation 71.47	336.34 meters Standard Deviation 64.94
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) Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 29	34.93 meters Standard Deviation 66.93	-0.76 meters Standard Deviation 50.94	14.81 meters Standard Deviation 37.21
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) Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 57	41.22 meters Standard Deviation 46.08	9.65 meters Standard Deviation 49.15	20.74 meters Standard Deviation 44.18
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) Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 85	45.99 meters Standard Deviation 49.65	6.47 meters Standard Deviation 53.47	0.44 meters Standard Deviation 68.54
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) Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Baseline	296.61 meters Standard Deviation 82.27	315.35 meters Standard Deviation 89.66	320.20 meters Standard Deviation 75.06
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) Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Cange at Day 29	28.65 meters Standard Deviation 48.12	-8.20 meters Standard Deviation 52.10	16.31 meters Standard Deviation 39.96
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) Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 57	27.67 meters Standard Deviation 49.80	1.94 meters Standard Deviation 54.31	15.52 meters Standard Deviation 47.63
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) Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 85	20.87 meters Standard Deviation 51.34	-6.17 meters Standard Deviation 58.31	2.23 meters Standard Deviation 80.61
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) Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Baseline	340.43 meters Standard Deviation 73.14	356.46 meters Standard Deviation 57.08	342.25 meters Standard Deviation 62.47
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) Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 29	19.61 meters Standard Deviation 64.46	16.13 meters Standard Deviation 34.82	14.82 meters Standard Deviation 47.47
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) Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 57	27.93 meters Standard Deviation 51.94	19.02 meters Standard Deviation 37.19	18.79 meters Standard Deviation 49.25
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) Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 85	37.02 meters Standard Deviation 57.85	20.42 meters Standard Deviation 43.24	15.38 meters Standard Deviation 45.94

SECONDARY outcome

Timeframe: Baseline up to Day 85 post dose.

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

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=69 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
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 ≥20 meter improvement at Day 85 : Males	21 participants	30 participants	22 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 ≥20 meter improvement at Day 85 : Females	17 participants	6 participants	12 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 ≥20 meter improvement at Day 85 : Younger than 65 years	15 participants	13 participants	15 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 ≥20 meter improvement at Day 85 : 65 Years and older	23 participants	13 participants	19 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 ≥20 meter improvement at Day 85 : BMI <18.9 kg/m^2	17 participants	12 participants	18 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 ≥20 meter improvement at Day 85 : BMI ≥18.9 kg/m^2	21 participants	14 participants	16 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 ≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted	16 participants	11 participants	14 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 ≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted	22 participants	15 participants	20 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 ≥10 meter improvement at Day 85 : Males	28 participants	24 participants	26 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 ≥10 meter improvement at Day 85 : Females	22 participants	10 participants	14 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 ≥10 meter improvement at Day 85 : Younger than 65 years	20 participants	17 participants	19 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 ≥10 meter improvement at Day 85 : 65 Years and older	30 participants	17 participants	21 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 ≥10 meter improvement at Day 85 : BMI <18.9 kg/m^2	24 participants	16 participants	19 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 ≥10 meter improvement at Day 85 : BMI ≥18.9 kg/m^2	26 participants	18 participants	21 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 ≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted	24 participants	16 participants	15 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 ≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted	26 participants	18 participants	25 participants

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=69 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
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	48.93 kg Standard Deviation 7.89	50.63 kg Standard Deviation 8.69	53.16 kg Standard Deviation 8.80
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Change at Day 8	0.31 kg Standard Deviation 0.72	0.78 kg Standard Deviation 0.77	1.00 kg Standard Deviation 0.90
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Change at Day 15	0.43 kg Standard Deviation 0.93	1.09 kg Standard Deviation 1.28	1.34 kg Standard Deviation 1.12
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Change at Day 22	0.44 kg Standard Deviation 1.14	1.36 kg Standard Deviation 1.40	1.68 kg Standard Deviation 1.42
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Change at Day 29	0.53 kg Standard Deviation 1.23	1.43 kg Standard Deviation 1.56	1.86 kg Standard Deviation 1.51
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Change at Day 43	0.48 kg Standard Deviation 1.42	1.62 kg Standard Deviation 1.68	2.03 kg Standard Deviation 1.63
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Change at Day 57	0.66 kg Standard Deviation 1.47	1.62 kg Standard Deviation 1.81	2.15 kg Standard Deviation 1.86
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Change at Day 85	0.90 kg Standard Deviation 1.71	1.75 kg Standard Deviation 2.27	2.44 kg Standard Deviation 2.18
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Change at Day 99	0.84 kg Standard Deviation 1.72	1.38 kg Standard Deviation 2.35	1.88 kg Standard Deviation 1.96

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=69 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
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 Change at Day 85	0.29 kg Standard Deviation 1.06	1.36 kg Standard Deviation 1.24	1.44 kg Standard Deviation 1.50
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 Change at Day 29	0.45 kg Standard Deviation 0.95	1.12 kg Standard Deviation 1.13	1.32 kg Standard Deviation 1.01
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 Change at Day 99	0.22 kg Standard Deviation 1.16	0.90 kg Standard Deviation 1.27	0.74 kg Standard Deviation 1.55
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	37.85 kg Standard Deviation 6.77	39.25 kg Standard Deviation 7.75	40.39 kg Standard Deviation 6.80

SECONDARY outcome

Timeframe: 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.

Population: Absolute concentrations of SUN11031 were assessed using the pharmacokinetic population.

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.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=74 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=76 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Predose 0 hrs, Day 1	49.09 pg/mL Standard Deviation 41.92	392.00 pg/mL Standard Deviation 2032.51	2125.02 pg/mL Standard Deviation 9355.92
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Predose 0 hrs, Day 1	58.93 pg/mL Standard Deviation 94.06	1083.62 pg/mL Standard Deviation 5600.63	79.49 pg/mL Standard Deviation 105.07
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Predose 0 hrs, Day 1	54.01 pg/mL Standard Deviation 72.46	727.64 pg/mL Standard Deviation 4147.16	1014.59 pg/mL Standard Deviation 6354.99
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Predose 0 hrs, Day 85	55.95 pg/mL Standard Deviation 68.44	46.51 pg/mL Standard Deviation 26.006	1090.10 pg/mL Standard Deviation 5491.94
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Predose 0 hrs, Day 85	49.37 pg/mL Standard Deviation 52.93	1493.67 pg/mL Standard Deviation 4939.87	258.34 pg/mL Standard Deviation 1052.19
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Predose 0 hrs, Day 85	52.72 pg/mL Standard Deviation 60.88	729.14 pg/mL Standard Deviation 3434.37	660.36 pg/mL Standard Deviation 3879.76
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57	42.51 pg/mL Standard Deviation 37.29	10967.36 pg/mL Standard Deviation 8543.58	22717.98 pg/mL Standard Deviation 16899.70
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57	278.61 pg/mL Standard Deviation 1278.26	16094.13 pg/mL Standard Deviation 12895.48	23107.50 pg/mL Standard Deviation 17012.10
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57	155.11 pg/mL Standard Deviation 883.60	13382.32 pg/mL Standard Deviation 10834.41	22918.34 pg/mL Standard Deviation 16823.84
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Postdose 0.5 Hrs, Day 85	415.01 pg/mL Standard Deviation 1990.46	9508.98 pg/mL Standard Deviation 6547.42	26420.12 pg/mL Standard Deviation 16539.03
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 0.5 Hrs, Day 85	415.01 pg/mL Standard Deviation 1990.46	9508.98 pg/mL Standard Deviation 6547.42	26420.12 pg/mL Standard Deviation 16539.03
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Postdose 1 Hr, Day 1	483.03 pg/mL Standard Deviation 2593.24	4761.62 pg/mL Standard Deviation 5209.23	14623.63 pg/mL Standard Deviation 13535.30
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 1 Hr, Day 1	483.03 pg/mL Standard Deviation 2593.24	4761.62 pg/mL Standard Deviation 5209.23	14623.63 pg/mL Standard Deviation 13535.30
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Postdose 1.5 Hrs, Day 29	27.28 pg/mL Standard Deviation 24.42	3086.34 pg/mL Standard Deviation 4433.97	6337.84 pg/mL Standard Deviation 5955.82
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 1.5 Hrs, Day 29	27.28 pg/mL Standard Deviation 24.42	3086.34 pg/mL Standard Deviation 4433.97	6337.84 pg/mL Standard Deviation 5955.82
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Postdose 3 Hrs, Day 85	43.80 pg/mL Standard Deviation 72.69	1137.22 pg/mL Standard Deviation 3218.04	2415.05 pg/mL Standard Deviation 5479.82
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 3 Hrs, Day 85	43.80 pg/mL Standard Deviation 72.69	1137.22 pg/mL Standard Deviation 3218.04	2415.05 pg/mL Standard Deviation 5479.83
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Postdose 4 Hrs, Day 1	52.99 pg/mL Standard Deviation 64.23	1156.16 pg/mL Standard Deviation 2859.47	473.67 pg/mL Standard Deviation 1038.69
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 4 Hrs, Day 1	52.99 pg/mL Standard Deviation 64.23	1156.16 pg/mL Standard Deviation 2859.47	473.67 pg/mL Standard Deviation 1038.69
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Postdose 6 Hrs, Day 57	51.39 pg/mL Standard Deviation 71.32	304.67 pg/mL Standard Deviation 1157.61	431.94 pg/mL Standard Deviation 1282.37
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 6 Hrs, Day 57	51.39 pg/mL Standard Deviation 71.32	304.67 pg/mL Standard Deviation 1157.61	431.94 pg/mL Standard Deviation 1282.37

SECONDARY outcome

Timeframe: 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.

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=74 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=76 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Predose 0 hrs, Day 1	183.03 pg/mL Standard Deviation 153.42	541.04 pg/mL Standard Deviation 2265.36	371.94 pg/mL Standard Deviation 868.91
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Predose 0 hrs, Day 1	189.79 pg/mL Standard Deviation 170.09	351.53 pg/mL Standard Deviation 1102.43	547.12 pg/mL Standard Deviation 1276.89
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Predose 0 hrs, Day 1	175.88 pg/mL Standard Deviation 135.75	754.23 pg/mL Standard Deviation 3103.32	234.63 pg/mL Standard Deviation 225.77
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Predose 0 hrs, Day 85	207.81 pg/mL Standard Deviation 227.93	196.17 pg/mL Standard Deviation 131.67	951.98 pg/mL Standard Deviation 3846.40
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Predose 0 hrs, Day 85	158.60 pg/mL Standard Deviation 131.94	459.03 pg/mL Standard Deviation 1059.43	824.12 pg/mL Standard Deviation 3095.66
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Predose 0 hrs, Day 85	184.03 pg/mL Standard Deviation 187.86	317.86 pg/mL Standard Deviation 731.38	886.97 pg/mL Standard Deviation 3455.15
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57	174.87 pg/mL Standard Deviation 186.0	5401.49 pg/mL Standard Deviation 4793.51	8680.49 pg/mL Standard Deviation 7747.93
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57	292.21 pg/mL Standard Deviation 655.71	6560.23 pg/mL Standard Deviation 4751.75	9519.43 pg/mL Standard Deviation 8835.18
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57	233.54 pg/mL Standard Deviation 481.75	5884.30 pg/mL Standard Deviation 4770.54	9106.62 pg/mL Standard Deviation 8261.72
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Postdose 0.5 Hrs, Day 85	417.51 pg/mL Standard Deviation 1407.84	6200.68 pg/mL Standard Deviation 5045.86	10819.65 pg/mL Standard Deviation 7950.18
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 0.5 Hrs, Day 85	417.51 pg/mL Standard Deviation 1407.84	6200.68 pg/mL Standard Deviation 5045.86	10819.65 pg/mL Standard Deviation 7950.18
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Postdose 1 Hr, Day 1	438.24 pg/mL Standard Deviation 1658.63	3071.61 pg/mL Standard Deviation 2422.07	7929.87 pg/mL Standard Deviation 7053.81
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 1 Hr, Day 1	438.24 pg/mL Standard Deviation 1658.63	3071.61 pg/mL Standard Deviation 2422.07	7929.87 pg/mL Standard Deviation 7053.81
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Postdose 1.5 Hrs, Day 29	105.15 pg/mL Standard Deviation 77.91	2230.16 pg/mL Standard Deviation 1920.22	4944.39 pg/mL Standard Deviation 4285.93
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 1.5 Hrs, Day 29	105.15 pg/mL Standard Deviation 77.91	2230.16 pg/mL Standard Deviation 1290.22	4944.39 pg/mL Standard Deviation 4285.93
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Postdose 3 Hrs, Day 85	128.21 pg/mL Standard Deviation 147.42	2381.54 pg/mL Standard Deviation 4226.73	2536.51 pg/mL Standard Deviation 1949.44
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 3 Hrs, Day 85	128.21 pg/mL Standard Deviation 147.42	2381.54 pg/mL Standard Deviation 4226.73	2536.51 pg/mL Standard Deviation 1949.44
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 2: Postdose 4 Hrs, Day 1	132.97 pg/mL Standard Deviation 126.11	1071.31 pg/mL Standard Deviation 1124.55	993.47 pg/mL Standard Deviation 1167.56
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 4 Hrs, Day 1	132.97 pg/mL Standard Deviation 126.11	1071.31 pg/mL Standard Deviation 1124.55	993.47 pg/mL Standard Deviation 1167.56
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1: Postdose 6 Hrs, Day 57	149.58 pg/mL Standard Deviation 166.07	577.37 pg/mL Standard Deviation 632.84	914.64 pg/mL Standard Deviation 769.17
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Seq 1+2: Postdose 6 Hrs, Day 57	149.58 pg/mL Standard Deviation 166.07	577.37 pg/mL Standard Deviation 632.84	914.64 pg/mL Standard Deviation 769.17

SECONDARY outcome

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

Population: Treatment-emergent adverse events were assessed using the safety population.

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.

Outcome measures

Outcome measures
Measure	Placebo n=73 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=75 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=76 Participants Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Hyperhidrosis	0 Participants	2 Participants	4 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Contusion	0 Participants	0 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Urinary tract infection	2 Participants	1 Participants	3 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Pharyngitis	1 Participants	0 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Sinusitis	2 Participants	1 Participants	0 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Tonsillitis	2 Participants	1 Participants	0 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Oral herpes	2 Participants	0 Participants	0 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Diarrhea	7 Participants	2 Participants	1 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Nausea	3 Participants	1 Participants	5 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Abdominal pain upper	0 Participants	4 Participants	3 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Toothache	2 Participants	0 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Abdominal pain	1 Participants	2 Participants	0 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Dry mouth	1 Participants	0 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Vomiting	2 Participants	0 Participants	1 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Injection site hematoma	7 Participants	3 Participants	7 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Injection site pain	2 Participants	4 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Chest pain	1 Participants	2 Participants	1 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Asthenia	3 Participants	0 Participants	1 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Thirst	0 Participants	0 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Back pain	1 Participants	4 Participants	3 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Arthralgia	1 Participants	1 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Myalgia	2 Participants	2 Participants	0 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Muscle spasms	0 Participants	1 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Hepatic enzyme increased	1 Participants	2 Participants	0 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Weight decreased	3 Participants	6 Participants	4 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Electrocardiogram QT prolonged	2 Participants	0 Participants	1 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Headache	5 Participants	4 Participants	5 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Dizziness	1 Participants	2 Participants	3 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Hypertension	4 Participants	1 Participants	1 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Hypotension	2 Participants	1 Participants	1 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Orthostatic hypotension	0 Participants	2 Participants	0 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Sinus tachycardia	0 Participants	2 Participants	0 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Hyperglycemia	2 Participants	2 Participants	1 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Hyperkalemia	1 Participants	2 Participants	0 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Insomnia	1 Participants	0 Participants	4 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Somnolence	2 Participants	0 Participants	1 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Depression	0 Participants	0 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Cholecystitis	0 Participants	0 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Number of Participants with at least 1 TEAE	58 Participants	59 Participants	56 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease COPD	23 Participants	20 Participants	16 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Dyspnea	1 Participants	2 Participants	3 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Bronchitis	4 Participants	5 Participants	3 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Nasopharyngitis	1 Participants	6 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Influenza	2 Participants	3 Participants	3 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Pneumonia	1 Participants	2 Participants	3 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease Gastroenteritis	2 Participants	2 Participants	2 Participants
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease upper respiratory tract infection	3 Participants	1 Participants	2 Participants

Adverse Events

Placebo

Serious events: 6 serious events

Other events: 54 other events

Deaths: 1 deaths

SUN11031 20 μg/kg

Serious events: 6 serious events

Other events: 54 other events

Deaths: 0 deaths

SUN11031 40 μg/kg

Serious events: 8 serious events

Other events: 47 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=73 participants at risk Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=75 participants at risk Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=76 participants at risk Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Respiratory, thoracic and mediastinal disorders COPD	31.5% 23/73 • Adverse event data were collected from 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.	26.7% 20/75 • Adverse event data were collected from 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.	21.1% 16/76 • Adverse event data were collected from 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.
Injury, poisoning and procedural complications Injection site hematoma	9.6% 7/73 • Adverse event data were collected from 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.	4.0% 3/75 • Adverse event data were collected from 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.	9.2% 7/76 • Adverse event data were collected from 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.
Nervous system disorders Headache	6.8% 5/73 • Adverse event data were collected from 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.	5.3% 4/75 • Adverse event data were collected from 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.	6.6% 5/76 • Adverse event data were collected from 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.
Investigations Weight decreased	4.1% 3/73 • Adverse event data were collected from 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.	8.0% 6/75 • Adverse event data were collected from 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.	5.3% 4/76 • Adverse event data were collected from 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.
Infections and infestations Bronchitis	5.5% 4/73 • Adverse event data were collected from 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.	6.7% 5/75 • Adverse event data were collected from 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.	3.9% 3/76 • Adverse event data were collected from 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.
Gastrointestinal disorders Diarrhea	9.6% 7/73 • Adverse event data were collected from 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.	2.7% 2/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
Infections and infestations Nasopharyngitis	1.4% 1/73 • Adverse event data were collected from 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.	8.0% 6/75 • Adverse event data were collected from 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.	2.6% 2/76 • Adverse event data were collected from 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.
Gastrointestinal disorders Nausea	4.1% 3/73 • Adverse event data were collected from 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.	1.3% 1/75 • Adverse event data were collected from 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.	6.6% 5/76 • Adverse event data were collected from 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.
Musculoskeletal and connective tissue disorders Back pain	1.4% 1/73 • Adverse event data were collected from 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.	5.3% 4/75 • Adverse event data were collected from 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.	3.9% 3/76 • Adverse event data were collected from 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.
General disorders Injection site pain	2.7% 2/73 • Adverse event data were collected from 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.	5.3% 4/75 • Adverse event data were collected from 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.	2.6% 2/76 • Adverse event data were collected from 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.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/73 • Adverse event data were collected from 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.	5.3% 4/75 • Adverse event data were collected from 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.	3.9% 3/76 • Adverse event data were collected from 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.
Vascular disorders Hypertension	5.5% 4/73 • Adverse event data were collected from 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.	1.3% 1/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
Psychiatric disorders Insomnia	1.4% 1/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	5.3% 4/76 • Adverse event data were collected from 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.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/73 • Adverse event data were collected from 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.	2.7% 2/75 • Adverse event data were collected from 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.	5.3% 4/76 • Adverse event data were collected from 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.

Additional Information

Contact for Clinical Trial Information

Daiichi Sankyo

Phone: 908-992-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=73 participants at risk Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks.	SUN11031 20 μg/kg n=75 participants at risk Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks.	SUN11031 40 μg/kg n=76 participants at risk Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks.
Renal and urinary disorders Renal Failure Acute	1.4% 1/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	0.00% 0/76 • Adverse event data were collected from 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.
Infections and infestations Pneumonia	1.4% 1/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
Respiratory, thoracic and mediastinal disorders COPD	2.7% 2/73 • Adverse event data were collected from 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.	4.0% 3/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
Gastrointestinal disorders Intestinal perforation	1.4% 1/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	0.00% 0/76 • Adverse event data were collected from 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.
Vascular disorders Hypotension	1.4% 1/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	0.00% 0/76 • Adverse event data were collected from 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.
Investigations Electrocardiogram QT prolonged	1.4% 1/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	0.00% 0/76 • Adverse event data were collected from 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/73 • Adverse event data were collected from 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.	1.3% 1/75 • Adverse event data were collected from 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.	0.00% 0/76 • Adverse event data were collected from 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.
Cardiac disorders Acute myocardial infarction	0.00% 0/73 • Adverse event data were collected from 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.	1.3% 1/75 • Adverse event data were collected from 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.	0.00% 0/76 • Adverse event data were collected from 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.
Cardiac disorders Atrial fibrillation	0.00% 0/73 • Adverse event data were collected from 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.	1.3% 1/75 • Adverse event data were collected from 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.	0.00% 0/76 • Adverse event data were collected from 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.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/73 • Adverse event data were collected from 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.	1.3% 1/75 • Adverse event data were collected from 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.	0.00% 0/76 • Adverse event data were collected from 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.
Psychiatric disorders Suicidal ideation	0.00% 0/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
Nervous system disorders Senile dementia	0.00% 0/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
Hepatobiliary disorders Cholecystitis	0.00% 0/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
Psychiatric disorders Completed suicide	0.00% 0/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
Vascular disorders Hypertensive crisis	0.00% 0/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
General disorders Chest pain	0.00% 0/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.
Gastrointestinal disorders Gastritis	0.00% 0/73 • Adverse event data were collected from 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.	0.00% 0/75 • Adverse event data were collected from 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.	1.3% 1/76 • Adverse event data were collected from 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.