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CachexiaPhase 2NCT00698828

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

A Phase 2 study testing SUN11031 20 μg/kg and SUN11031 40 μg/kg in people with Cachexia, run by Daiichi Sankyo at 43 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Cachexia
What is being tested?
SUN11031 20 μg/kg and SUN11031 40 μg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
227 participants
Where
43 sitesin 6 countries
Study dates
15 May 2008to 8 Oct 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each participant had to meet the following criteria to be enrolled in the study:
  • 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
  • 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.
  • Chest x-ray within the past year that was compatible with COPD
  • 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
  • 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)

Who cannot join

  • Participants who met any of the following criteria were excluded from the study:
  • BMI greater than 26 kg/m^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
  • 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)
  • Weight loss that was considered to be, in the opinion of the investigator, the result of food deprivation
  • Unintended weight loss that may have been due to disease other than COPD
Show all 27Show fewer
  • 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
  • Severe anemia (hemoglobin less than or equal to 8 g/dL)
  • 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
  • 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
  • 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)
  • 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
  • Pulmonary embolism, deep venous thrombosis, or clinically significant primary pulmonary hypertension within the past 6 months
  • Significant ischemic heart disease or chronic heart failure (New York Heart Association Class IV cardiac disease)
  • Uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 110 mm Hg)
  • 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)
  • Evidence of ascites, pleural effusion, or lower extremity edema
  • Severe vitamin D deficiency (25-hydroxyvitamin D less than 10 ng/mL)
  • Known mechanical obstruction of the alimentary tract and/or malabsorption
  • Dental or swallowing problems that may have had a negative effect on food intake
  • 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
  • A diagnosis of human immunodeficiency virus infection or AIDS
  • 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
  • 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
  • Hypersensitive to any component of SUN11031, or participated at any time in any study in which SUN11031 was administered
  • Received an investigational drug or product, or participated in a drug study within 30 days before screening
  • 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

Trial locations and contacts

43 sites in 6 countries.

43 sites in 6 countries

Argentina18 sites

  • Centro de Investigación Médica Lanús

    Buenos Aires

  • FAICEP

    Capital Federal, C1122AAK

  • Instituto Médico de Asistencia e Investigación

    Capital Federal, C1425AWC

  • Centro Médico Dra. De Salvo

    Capital Federal, C1426ABP

  • Centro Médico Belgrano

    Capital Federal, C1429BNQ

  • Centro Ceri

    Capital Federal

  • Centro de Estudios Neumonologicos

    Capital Federal

  • Instituto de Investigaciones Clínicas Cipolletti

    Cipolletti, Río Negro Province, R8324EMD

  • Centro de Investigaciones Médicas

    Florencío Varela, Buenos Aires

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, Buenos Aires

  • Fuesmen

    Mendoza, cp 5500

  • Instituto de Enfermedades Respiratorias

    Mendoza

  • Centro de Medicina Respiratoria

    Paraná

  • Centro Respiratorio Quilmes

    Quilmes, Buenos Aires, B1878FNR

  • Clinica del Tórax

    Rosario, Santa Fe Province, S2000DBS

  • Instituto Cardiovascular de Rosario

    Rosario, Santa Fe Province, S2000DSV

  • CEMIT

    San Miguel de Tucumán, Tucumán Province

  • Instituto de Patologia Respiratoria

    San Miguel de Tucumán

Other trials in Argentina

United States11 sites

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45252

  • Clinical Research of West Florida

    Clearwater, Florida, 33765

  • Health Science Research Center - Asthma & Allergy Associates

    Cortland, New York, 13045

  • The Center for Clinical Research, Washington County Hospital

    Hagerstown, Maryland, 21740

  • Innovative Research of West Florida

    Largo, Florida, 33756

  • Clinical Research Institute of Southern Oregon

    Medford, Oregon, 97504

  • Montana Medical Research, Inc.

    Missoula, Montana, 59808

  • The Asthma & Allergy Center

    Papillion, Nebraska, 68046

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Pulmonary Consultants

    Tacoma, Washington, 98405

  • Waterbury Pulmonary Associates

    Waterbury, Connecticut, 06708

Other trials in United States

Romania5 sites

  • Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca

    Cluj-Napoca, Cluj, 400371

  • Spitalul Clinic de Pneumoftiziologie "Leon Daniello" Cluj-Napoca

    Cluj-Napoca, 400371

  • Spitalul Clinic de Pneumoftiziologie Constanta, Cartier Palazul Mare

    Constanța, 900002

  • Spitalul Clinic Judetean Sibiu, Clinica Medicala

    Sibiu, 550245

  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologoe "Dr. Victor Babes"

    Timișoara, Timiș County, 300310

Other trials in Romania

Guatemala4 sites

  • Instituto Pneos

    Guatemala City, 01010

  • Edificio Centro Medico II

    Guatemala City

  • Private Clinic

    Guatemala City

  • Edificio Medico San Lucas

    Quetzaltenango

Other trials in Guatemala

Chile3 sites

  • Hospital Barros Luco Trudeau

    Santiago

  • Hospital San Jose

    Santiago

  • Integramedica La Florida

    Santiago

Other trials in Chile

Honduras2 sites

  • Centro de Neumologia y Alergia

    San Pedro Sula

  • Instituto Nacional Cardiopulmonar

    Tegucigalpa

Other trials in Honduras

About this study

Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SUN11031 for Injection Administered Subcutaneously Twice Daily for 12 Weeks to Subjects Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

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.

Conditions
Cachexia
Being tested
Placebo comparator, SUN11031 20 μg/kg, SUN11031 40 μg/kg
Keywords
Cachexia, COPD, Chronic Obstructive Pulmonary Disease
Medical subject headings
Cachexia, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo comparatorDrug

    Twice daily subcutaneous injections of placebo for 12 weeks.

  • SUN11031 20 μg/kgDrug

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

  • SUN11031 40 μg/kgDrug

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

Study groups in NCT00698828
Study groupRoleWhat they receive
Group 1ExperimentalSUN11031 for injection, low dose, twice daily for 12 weeks
Receives: Drug: SUN11031 20 μg/kg
Group 2ExperimentalSUN11031 for injection, higher dose, twice daily for 12 weeks
Receives: Drug: SUN11031 40 μg/kg
Group 3Placebo comparatorPlacebo injection, twice daily for 12 weeks
Receives: Drug: Placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

    Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites.

    Measured: Baseline up to Day 85 post dose.

Secondary outcomes (8)

  1. Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

    Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites.

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

  2. Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)

    Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites.

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

  3. Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

    Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites.

    Measured: Baseline up to Day 85 post dose.

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

    Measurements of body weight were performed in the morning when the participant had an empty stomach (ie, had consumed no food overnight) and had emptied the bladder and had a bowel movement, if possible. These measurements were performed using the same calibrated scale for an individual participant throughout study.

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

  5. Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease

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

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

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

    Absolute concentrations of SUN11031 in participant plasma samples were measured. When participants were randomly assigned into 1 of 3 treatment groups at baseline, they were also randomly assigned into 1 of 2 sequences in the pharmacokinetic (PK) sparse sampling schedule based on the randomization number.

    Measured: Day 1 and Day 85 pre-dose; Day 1 at 1 hour and 4 hours; Day 29 at 0.08 hours and 1.5 hours; Day 57 at 0.08 hours and 6 hours; Day 85 at 0.5 hours and 3 hours postdose.

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

    Absolute concentrations of SUN11031 metabolites desacyl-ghrelin in participant plasma samples were measured. When participants were randomly assigned into 1 of 3 treatment groups at baseline, they were also randomly assigned into 1 of 2 sequences in the pharmacokinetic (PK) sparse sampling schedule based on the randomization number.

    Measured: Day 1 and Day 85 pre-dose; Day 1 at 1 hour and 4 hours; Day 29 at 0.08 hours and 1.5 hours; Day 57 at 0.08 hours and 6 hours; Day 85 at 0.5 hours and 3 hours postdose.

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

    Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred from the time treatment was administered at Day 1 through the last follow-up visit or a worsening of a pre-existing condition.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2008 (estimated)
  2. Study start15 May 2008
  3. Primary completion8 Oct 2009
  4. Study completion8 Oct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00698828
Sponsor's protocol ID
ASBI 307
Status last verified
Jan 2021
First submitted
1 May 2008
Last updated
28 Jan 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SUN11031 20 μg/kg and SUN11031 40 μg/kg in people with Cachexia, run by Daiichi Sankyo at 43 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Argentina, United States, Romania, Guatemala, Chile and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Baseline up to Day 85 post dose.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00698828.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.

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