Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT03591718
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2018-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Test Different Doses of BI 456906 in Patients With Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000726451', 'term': 'BI 456906'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-07-09', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative number [N (%)] of patients withdrawn from up-titration by up-titration scheme', 'timeFrame': 'Up to 132 days'}], 'secondaryOutcomes': [{'measure': 'AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)', 'timeFrame': 'Up to 168 hours'}, {'measure': 'Cmax (maximum measured concentration of the analyte in plasma) after first dose', 'timeFrame': 'Up to 132 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '36527386', 'type': 'DERIVED', 'citation': 'Jungnik A, Arrubla Martinez J, Plum-Morschel L, Kapitza C, Lamers D, Thamer C, Scholch C, Desch M, Hennige AM. Phase I studies of the safety, tolerability, pharmacokinetics and pharmacodynamics of the dual glucagon receptor/glucagon-like peptide-1 receptor agonist BI 456906. Diabetes Obes Metab. 2023 Apr;25(4):1011-1023. doi: 10.1111/dom.14948. Epub 2023 Jan 30.'}], 'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Main objective is to investigate the tolerability of different titration schemes of BI 456906 in otherwise healthy patients with obesity/overweight, and to determine a titration scheme for future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients ≥ 18 years and \\< 70 years of age at screening\n* Body Mass Index (BMI) ≥ 27 kg/m2 and \\<40 kg/m2 at screening\n* A minimum absolute body weight of 70 kg at screening and a stable body weight (defined as no more than 5% change) 3 months prior to screening\n* HbA1c \\<6.5%\n* Further inclusion criteria apply\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing, or who plan to become pregnant while in the trial\n* Supine blood pressure (BP) ≥160/100 mmHg at screening\n* Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 12 months after screening\n* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n* Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT03591718', 'briefTitle': 'A Study to Test Different Doses of BI 456906 in Patients With Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase I, Blinded Within Dose Groups, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Titration Schemes of BI 456906 in Patients With Obesity and Overweight.', 'orgStudyIdInfo': {'id': '1404-0003'}, 'secondaryIdInfos': [{'id': '2018-000250-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 456906', 'interventionNames': ['Drug: BI 456906']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BI 456906', 'type': 'DRUG', 'description': 'Solution for injection', 'armGroupLabels': ['BI 456906']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'solution for injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55116', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Profil Mainz GmbH & Co. KG', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institut für Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. Studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. Studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http:// trials.boehringer-ingelheim.com/ to: 1.find information in order to request access to clinical study data, for listed studies. 2.request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement'."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}