SUN11031 in Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Cachexia
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Wasting Syndrome; Cachexia
Intervention: Placebo comparator; SUN11031 20 μg/kg; SUN11031 40 μg/kg
Intervention description: Twice daily subcutaneous injections of placebo for 12 weeks.; Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks.; Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 227.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Cachexia, COPD, Chronic Obstructive Pulmonary Disease

Summary:

      To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia
      associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on
      physical performance and body composition.
    

Eligibility criteria:

        Inclusion Criteria:

        Each participant had to meet the following criteria to be enrolled in the study:

          1. Male or non-pregnant female participants 50 years or older with a clinical diagnosis
             of Chronic Obstructive Pulmonary Disease (COPD) for greater than or equal to 12 months

          2. Walked a distance of greater than or equal to 100 but less than or equal to 450 meters
             during the 6-Minute Walk Test (MWT) performed at screening.

          3. Chest x-ray within the past year that was compatible with COPD

          4. Documented involuntary nonedematous weight loss of greater than 5% of participant's
             usual body weight over the past 12 months or BMI less than or equal to 21 kg/m^2 for
             males or Body Mass Index (BMI) less than or equal to 20 kg/m^2 for females

          5. Female participants who were clinically sterile (eg, either postmenopausal or had
             undergone a tubal ligation or hysterectomy) or were practicing a medically acceptable
             method of birth control (eg, oral, transdermal, implantable, or injectable
             contraceptive medications; double-barrier method or intrauterine device)

        Exclusion Criteria:

        Participants who met any of the following criteria were excluded from the study:

          1. BMI greater than 26 kg/m^2

          2. Used, over a total of 7 or more days, parenteral corticosteroids at a dose equivalent
             to prednisone at greater than or equal to 5 mg/day or oral corticosteroids at a dose
             equivalent to prednisone at greater than 10 mg/day within the 2 months before
             screening; however, participants were allowed to participate if on stable doses
             equivalent to prednisone at less than or equal to 10 mg/day for at least 2 months
             before screening, and were planning to remain on the same stable dose throughout the
             study

          3. Were planning to start a pulmonary rehabilitation program during the study
             (participant may have been enrolled in the study if he or she was currently on a
             stable maintenance program)

          4. Weight loss that was considered to be, in the opinion of the investigator, the result
             of food deprivation

          5. Unintended weight loss that may have been due to disease other than COPD

          6. Unable or unwilling to be trained to self-administer the study drug by subcutaneous
             injection bid, and for whom arrangements could not be made for a third party to
             reliably administer the injections

          7. Severe anemia (hemoglobin less than or equal to 8 g/dL)

          8. COPD exacerbation defined as a Type 1 or 2 exacerbation according to the Winnipeg
             criteria, acute infection, or prolonged fever within 4 weeks before screening

          9. Undergoing treatment or evaluation for cancer, or had a history of treatment for
             cancer within the past 3 years, exception being nonmelanoma skin cancer (basal cell or
             squamous cell carcinoma of the skin) and carcinoma in situ of the cervix

         10. Type I or type II diabetes mellitus or a fasting serum glucose of greater than or
             equal to 115 mg/dL (6.4 mmol/L) (fasting was overnight)

         11. Serious disease or conditions that would have interfered with the participant's
             ability to complete the functional measures included in this protocol; or any illness
             that, in the opinion of the investigator, might have interfered with the results of
             the study or the participant's ability to participate

         12. Pulmonary embolism, deep venous thrombosis, or clinically significant primary
             pulmonary hypertension within the past 6 months

         13. Significant ischemic heart disease or chronic heart failure (New York Heart
             Association Class IV cardiac disease)

         14. Uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic
             blood pressure greater than 110 mm Hg)

         15. A history of symptomatic orthostatic hypotension or syncope; or orthostatic
             hypotension at screening or baseline (Days -6 to -3) (orthostatic hypotension was
             defined as a decrease in systolic blood pressure by greater than or equal to 20 mm Hg
             measured after 2 minutes in a standing position compared with the systolic blood
             pressure measured after 10 minutes in a supine position)

         16. Evidence of ascites, pleural effusion, or lower extremity edema

         17. Severe vitamin D deficiency (25-hydroxyvitamin D less than 10 ng/mL)

         18. Known mechanical obstruction of the alimentary tract and/or malabsorption

         19. Dental or swallowing problems that may have had a negative effect on food intake

         20. Serum creatinine greater than 2.5 mg/dL; or alanine aminotransferase, aspartate
             aminotransferase, or gamma-glutamyl transferase greater than 3 times the upper limit
             of normal, or bilirubin greater than 2.5 mg/dL

         21. A diagnosis of human immunodeficiency virus infection or AIDS

         22. Used any prescription drugs and non-prescription drugs/herbs that cause weight loss or
             affect appetite and absorption or that may cause nausea; or used appetite-promoting or
             anabolic medications within 15 days before screening

         23. A history of alcohol or drug abuse that, in the opinion of the investigator, would
             have interfered with the participant's ability to comply with the dosing schedule and
             protocol-specified requirements

         24. Hypersensitive to any component of SUN11031, or participated at any time in any study
             in which SUN11031 was administered

         25. Received an investigational drug or product, or participated in a drug study within 30
             days before screening

         26. Non-ambulatory or unwilling to cooperate fully with the investigator or a designee, or
             unwilling or unable to comply with study requirements, such as all assessments
             required by the protocol, including completion of measures for functional capacity and
             pulmonary function, or frequent blood sampling and meal instructions; or unable or
             unwilling to attend all study visits