Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-29 @ 2:35 AM
Study NCT ID:
NCT04159766
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2019-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study With NLY01 in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-08', 'lastUpdatePostDateStruct': {'date': '2021-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Treatment Emergent Adverse Events', 'timeFrame': '35 days'}, {'measure': 'Number of Incidences of Adverse Events', 'timeFrame': '35 days'}, {'measure': 'Plasma glucose', 'timeFrame': '24 hours', 'description': 'Change of fasting glucose profiles'}, {'measure': 'Change in serum insulin', 'timeFrame': '24 hours', 'description': 'Change in 24 hour serum insulin'}, {'measure': 'Change in plasma glucagon', 'timeFrame': '24 hours', 'description': 'Change in 24 hour plasma glucagon concentrations'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2a study designed to assess the effect of NLY01 in patients with type 2 diabetes. Patients will be monitored for safety, pharmacokinetics, and pharmacodynamic effects on glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject with type 2 diabetes for at least one year\n* Willing to continue treatment with metformin at the same dose and frequency until and (if applicable) to pause any treatment with a second oral antidiabetic\n* Body Mass Index (BMI) 22.0 to 35.0 kg/m\\^2,\n\nExclusion Criteria:\n\n* History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.\n* Any history or presence of clinically relevant comorbidity (with the exception of conditions associated with diabetes mellitus), that may place the subject at increased risk as determined by the investigator\n* Any prior exposure to an exenatide-based product (BYETTA and BYDUREON)\n* History of gastroparesis\n* History of severe hypoglycemia in the past 6 months\n* If female, pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04159766', 'briefTitle': 'A Study With NLY01 in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuraly, Inc.'}, 'officialTitle': 'A Phase 2a Dose-Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NLY01, a PEGylated Exenatide, When Administered as a Single Dose in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'NLY01-D1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NLY01 (2.5 mg)', 'interventionNames': ['Drug: NLY01']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NLY01 (5.0 mg)', 'interventionNames': ['Drug: NLY01']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NLY01 (10 mg)', 'interventionNames': ['Drug: NLY01']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'NLY01', 'type': 'DRUG', 'description': 'NLY01, a PEGylated form of the anti-diabetic peptide exenatide', 'armGroupLabels': ['NLY01 (10 mg)', 'NLY01 (2.5 mg)', 'NLY01 (5.0 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'normal saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institute fur Stoffwechselforschung GmbH', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}, {'zip': 'D-41460', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Profil Institute', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}], 'overallOfficials': [{'name': 'Dan Lee', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neuraly, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuraly, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}