Nctid:
NCT06615700
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D000003924", "term"=>"Diabetes Mellitus, Type 2"}, {"id"=>"D000050177", "term"=>"Overweight"}], "ancestors"=>[{"id"=>"D000044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D000008659", "term"=>"Metabolic Diseases"}, {"id"=>"D000004700", "term"=>"Endocrine System Diseases"}, {"id"=>"D000044343", "term"=>"Overnutrition"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}, {"id"=>"D000001835", "term"=>"Body Weight"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M26186", "name"=>"Overweight", "asFound"=>"Overweight", "relevance"=>"HIGH"}, {"id"=>"M7115", "name"=>"Diabetes Mellitus", "asFound"=>"Diabetes", "relevance"=>"HIGH"}, {"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "asFound"=>"Type 2 Diabetes", "relevance"=>"HIGH"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}, {"id"=>"M25307", "name"=>"Overnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>74}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-05-06", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-09-20", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-08-12", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Incidence of Treatment-Emergent Adverse Events in NA-931 participants", "timeFrame"=>"28 days", "description"=>"To evaluate the safety and tolerability of NA-931"}], "secondaryOutcomes"=>[{"measure"=>"Maximum observe drug concentration (Cmax) of NA-931", "timeFrame"=>"28 days", "description"=>"Pharmacokinetics (PK) Cmax"}, {"measure"=>"Effect of a High-Fat Meal on Plasma Concentration of NA-931", "timeFrame"=>"28 days", "description"=>"Determine the effect of a high-fat meal on the Pharmacokinetics of NA-931following a single dose"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["NA-931, obesity, Type 2 Diabetes, Biomed Industries, Inc"], "conditions"=>["Overweight or Obesity", "Type 2 Diabetes"]}, "descriptionModule"=>{"briefSummary"=>"A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.", "detailedDescription"=>"A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with Type 2 Diabetes Mellitus.\n\nNA-931 is a Quadruple Receptor Agonist for Insulin Like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Gastric Inhibitory Polypeptide (GIP) and Glucagon."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Participants 18-65 years old, inclusive\n* BMI of 25 - 40, inclusive\n* Stable body weight for two months\n* Participants must be capable of giving signed informed consent\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures\n* Willing to comply with contraception requirements\n\nExclusion Criteria:\n\n* History of significant medical conditions and malignancy\n* Uncontrollable hypertension\n* History of alcoholism or drug addiction within 1 year prior to Screening\n* Current or recent participation in an investigational clinical trial\n* Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption"}, "identificationModule"=>{"nctId"=>"NCT06615700", "acronym"=>"T2DM", "briefTitle"=>"Phase 1 to Study Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NA-931 in Obese Participants and Patients With Type 2 Diabetes Mellitus", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Biomed Industries, Inc."}, "officialTitle"=>"A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NA-931 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus", "orgStudyIdInfo"=>{"id"=>"NA-931-50"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Participant Group/Arm- NA-931", "description"=>"Experimental: NA-931 Capsule of NA-931 intervention", "interventionNames"=>["Drug: NA-931"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Participant Group/Arm- Placebo", "description"=>"Placebo Comparator: Placebo Capsule of placebo", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"NA-931", "type"=>"DRUG", "otherNames"=>["NA-931 is a quadruple receptor agonist"], "description"=>"NA-931 is a quadruple receptor agonist for weight loss", "armGroupLabels"=>["Participant Group/Arm- NA-931"]}, {"name"=>"Placebo", "type"=>"DRUG", "otherNames"=>["Placebo of NA-931"], "description"=>"Placebo of NA-931", "armGroupLabels"=>["Participant Group/Arm- Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"2050", "city"=>"Camperdown", "state"=>"New South Wales", "country"=>"Australia", "facility"=>"Biomed Industries Pty Limited- Clinical Testing Site 1", "geoPoint"=>{"lat"=>-33.88965, "lon"=>151.17642}}, {"zip"=>"3052", "city"=>"Parkville", "state"=>"Victoria", "country"=>"Australia", "facility"=>"Biomed Industries, Pty Limited Testing Site 2", "geoPoint"=>{"lat"=>-37.78333, "lon"=>144.95}}], "overallOfficials"=>[{"name"=>"Lloyd Tran, PhD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Biomed Industries, Inc."}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Biomed Industries, Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
