Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-03-06 @ 10:55 PM
Study NCT ID:
NCT01388920
Status:
TERMINATED
Last Update Posted:
2022-03-18
First Post:
2011-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479538', 'term': 'tesamorelin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmamputu@theratech.com', 'phone': '514-336-7800', 'title': 'Senior Medical Advisor', 'organization': 'Theratechnologies'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tesamorelin 2 mg', 'description': 'Tesamorelin 2 mg/day for 6 months', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tesamorelin 3 mg', 'description': 'Tesamorelin 3 mg/day for 6 months', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo for 6 months', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Lean Body Mass at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tesamorelin 2 mg', 'description': 'Tesamorelin 2 mg/day for 6 months'}, {'id': 'OG001', 'title': 'Tesamorelin 3 mg', 'description': 'Tesamorelin 3 mg/day for 6 months'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo for 6 months'}], 'timeFrame': '6 months', 'description': 'The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary objective of the study was the change in lean body mass between baseline and Month 6. However, the study was halted approximately 1 month after patient enrollment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Exercise Capacity at 6 Months', 'timeFrame': '6 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peripheral Muscle Strength at 6 Months', 'timeFrame': '6 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-reported Outcomes at 6 Months', 'timeFrame': '6 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'timeFrame': '6 months', 'description': 'Number and percentage of subjects with adverse events', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'COPD Exacerbations', 'timeFrame': '6 months', 'description': 'Frequency and severity of COPD exacerbations', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Plasma Glucose', 'timeFrame': '6 months', 'description': 'Changes from baseline in fasting blood glucose', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tesamorelin 2 mg', 'description': 'Tesamorelin 2 mg/day for 6 months'}, {'id': 'FG001', 'title': 'Tesamorelin 3 mg', 'description': 'Tesamorelin 3 mg/day for 6 months'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo for 6 monts'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tesamorelin 2 mg', 'description': 'Tesamorelin 2 mg/day for 6 months'}, {'id': 'BG001', 'title': 'Tesamorelin 3 mg', 'description': 'Tesamorelin 3 mg/day for 6 months'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo for 6 months'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '0', 'groupId': 'BG000'}, {'value': '51', 'spread': '0', 'groupId': 'BG001'}, {'value': '55', 'spread': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'The study was terminated based on a non-safety related corporate decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-09', 'studyFirstSubmitDate': '2011-07-05', 'resultsFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2011-07-05', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-04', 'studyFirstPostDateStruct': {'date': '2011-07-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Lean Body Mass at 6 Months', 'timeFrame': '6 months', 'description': 'The primary objective of the study was to evaluate the effect of tesamorelin on lean body mass by Dual-energy X-ray absorptiometry (DXA) scan'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Exercise Capacity at 6 Months', 'timeFrame': '6 months'}, {'measure': 'Change From Baseline in Peripheral Muscle Strength at 6 Months', 'timeFrame': '6 months'}, {'measure': 'Change From Baseline in Patient-reported Outcomes at 6 Months', 'timeFrame': '6 months'}, {'measure': 'Adverse Events', 'timeFrame': '6 months', 'description': 'Number and percentage of subjects with adverse events'}, {'measure': 'COPD Exacerbations', 'timeFrame': '6 months', 'description': 'Frequency and severity of COPD exacerbations'}, {'measure': 'Plasma Glucose', 'timeFrame': '6 months', 'description': 'Changes from baseline in fasting blood glucose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Muscle wasting'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'A significant proportion of COPD subjects experience muscle wasting, which has been associated with increased morbidity, impaired physical functioning, and a poor quality of life.\n\nMuscle wasting is associated with reduced muscle strength in COPD subjects. In particular, weakness of peripheral muscles has been reported to play an important role in the reduced functional capacity and impaired exercise performance.\n\nThe primary objective of this study is to investigate the effect of tesamorelin, in conjunction with exercise training, on lean body mass measured by dual energy x-ray absorptiometry (DXA) scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged 40-75 years (y) inclusive\n* Documented diagnosis of moderate to very severe COPD (GOLD stage 2, 3, or 4)\n* Stable COPD (i.e., no exacerbation) for at least 6 weeks prior to screening\n* Able to participate in a supervised exercise training program\n* Evidence of muscle wasting\n\nExclusion Criteria\n\n* Participation in a pulmonary rehabilitation program or in any supervised exercise program during the 4 months prior to screening\n* More than 4 exacerbations in the year prior to screening\n* Life-threatening exacerbation in the year prior to screening\n* Requirement for long-term oxygen therapy (\\> 12 hours of oxygen per day)\n* Critical illness or co-morbid conditions that may interfere with study conduct or endpoint measurements\n* Use of agents known to increase lean body mass within 3 months prior to screening\n* Hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma'}, 'identificationModule': {'nctId': 'NCT01388920', 'briefTitle': 'Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theratechnologies'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Doses of Tesamorelin in Stable Ambulatory COPD Subjects With Muscle Wasting', 'orgStudyIdInfo': {'id': 'TH9507-CTR-1025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tesamorelin 2 mg', 'description': 'Tesamorelin 2 mg/day', 'interventionNames': ['Drug: Tesamorelin']}, {'type': 'EXPERIMENTAL', 'label': 'Tesamorelin 3 mg', 'description': 'Tesamorelin 3 mg/day', 'interventionNames': ['Drug: Tesamorelin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tesamorelin', 'type': 'DRUG', 'armGroupLabels': ['Tesamorelin 2 mg', 'Tesamorelin 3 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richard Casaburi, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theratechnologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}