Nctid:
NCT06230523
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000009765", "term"=>"Obesity"}, {"id"=>"D000050177", "term"=>"Overweight"}], "ancestors"=>[{"id"=>"D000044343", "term"=>"Overnutrition"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}, {"id"=>"D000001835", "term"=>"Body Weight"}], "browseLeaves"=>[{"id"=>"M26186", "name"=>"Overweight", "asFound"=>"Overweight", "relevance"=>"HIGH"}, {"id"=>"M12701", "name"=>"Obesity", "asFound"=>"Obesity", "relevance"=>"HIGH"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M25307", "name"=>"Overnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>250}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-02-05", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-09", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-01-21", "studyFirstSubmitQcDate"=>"2024-01-21", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-06", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Percent Change from Baseline in Body Weight", "timeFrame"=>"Baseline, Week 48"}], "secondaryOutcomes"=>[{"measure"=>"Change from Baseline in Body Weight", "timeFrame"=>"Baseline, Week 48"}, {"measure"=>"Percentage of Participants Who Achieve ≥5% Body Weight Reduction", "timeFrame"=>"Baseline to Week 48"}, {"measure"=>"Percentage of Participants Who Achieve ≥10% Body Weight Reduction", "timeFrame"=>"Baseline to Week 48"}, {"measure"=>"Change from Baseline in Body Mass Index (BMI)", "timeFrame"=>"Baseline, Week 48"}, {"measure"=>"Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136", "timeFrame"=>"Baseline to Week 48"}, {"measure"=>"PK: Maximum Concentration (Cmax) of LY3841136", "timeFrame"=>"Baseline to Week 48"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Overnutrition", "Hormones", "Chronic weight management"], "conditions"=>["Obesity", "Overweight and Obesity"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://trials.lilly.com/en-US/trial/454455", "label"=>"A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight"}]}, "descriptionModule"=>{"briefSummary"=>"The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may include up to 17 visits."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nW8M-MC-LAA1\n\n* Are males and females who agree to abide by the reproductive and contraceptive requirements\n\nW8M-MC-CWMM:\n\n* Have a BMI ≥27 kg/m²\n* Have had a stable body weight for the 3 months prior to randomization (\\<5% body weight gain and/or loss)\n\nExclusion Criteria:\n\nW8M-MC-LAA1\n\n* Have any prior diagnosis of diabetes mellitus except gestational diabetes.\n* Have any of the following cardiovascular conditions within 6 months prior to screening:\n\n * acute myocardial infarction\n * cerebrovascular accident (stroke)\n * unstable angina, or\n * hospitalization due to congestive heart failure (CHF).\n* Have a history of acute or chronic pancreatitis.\n* Have an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.\n\nW8M-MC-CWMM\n\n* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \\>1 year prior to screening.\n* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.\n* Have poorly controlled hypertension.\n* Have a history of symptomatic gallbladder disease within the past 2 years\n* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.\n* Have a lifetime history of suicide attempts."}, "identificationModule"=>{"nctId"=>"NCT06230523", "briefTitle"=>"A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Eli Lilly and Company"}, "officialTitle"=>"A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight", "orgStudyIdInfo"=>{"id"=>"18808"}, "secondaryIdInfos"=>[{"id"=>"W8M-MC-LAA1", "type"=>"OTHER", "domain"=>"Intervention-specific appendix (ISA) number"}, {"id"=>"CWMM Master Protocol", "type"=>"OTHER", "domain"=>"Eli Lilly and Company"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"LY3841136 Dose 1", "description"=>"Participants will receive LY3841136 subcutaneously (SC)", "interventionNames"=>["Drug: LY3841136"]}, {"type"=>"EXPERIMENTAL", "label"=>"LY3841136 Dose 2", "description"=>"Participants will receive LY3841136 SC", "interventionNames"=>["Drug: LY3841136"]}, {"type"=>"EXPERIMENTAL", "label"=>"LY3841136 Dose 3", "description"=>"Participants will receive LY3841136 SC", "interventionNames"=>["Drug: LY3841136"]}, {"type"=>"EXPERIMENTAL", "label"=>"LY3841136 Dose 4", "description"=>"Participants will receive LY3841136 SC.", "interventionNames"=>["Drug: LY3841136"]}, {"type"=>"EXPERIMENTAL", "label"=>"LY3841136 Dose 5", "description"=>"Participants will receive LY3841136 SC", "interventionNames"=>["Drug: LY3841136"]}, {"type"=>"EXPERIMENTAL", "label"=>"LY3841136 Dose 6", "description"=>"Participants will receive LY3841136 SC", "interventionNames"=>["Drug: LY3841136"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Participants will receive LY3841136 matching placebo", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"LY3841136", "type"=>"DRUG", "description"=>"Administered SC.", "armGroupLabels"=>["LY3841136 Dose 1", "LY3841136 Dose 2", "LY3841136 Dose 3", "LY3841136 Dose 4", "LY3841136 Dose 5", "LY3841136 Dose 6"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"Administered SC.", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85225", "city"=>"Chandler", "state"=>"Arizona", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"The Institute for Liver Health II dba Arizona Clinical Trials - Mesa", "geoPoint"=>{"lat"=>33.30616, "lon"=>-111.84125}}, {"zip"=>"85260", "city"=>"Scottsdale", "state"=>"Arizona", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Headlands Research - Scottsdale", "geoPoint"=>{"lat"=>33.50921, "lon"=>-111.89903}}, {"zip"=>"85712", "city"=>"Tucson", "state"=>"Arizona", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"The Institute for Liver Health II dba Arizona Liver Health-Tucson", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"94904", "city"=>"Greenbrae", "state"=>"California", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"NorCal Medical Research, Inc", "geoPoint"=>{"lat"=>37.94854, "lon"=>-122.5247}}, {"zip"=>"90255", "city"=>"Huntington Park", "state"=>"California", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Velocity Clinical Research, Huntington Park", "geoPoint"=>{"lat"=>33.98168, "lon"=>-118.22507}}, {"zip"=>"90274", "city"=>"Rolling Hills Estates", "state"=>"California", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Peninsula Research Associates", "geoPoint"=>{"lat"=>33.78779, "lon"=>-118.35813}}, {"zip"=>"94598", "city"=>"Walnut Creek", "state"=>"California", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Diablo Clinical Research, Inc.", "geoPoint"=>{"lat"=>37.90631, "lon"=>-122.06496}}, {"zip"=>"32003", "city"=>"Fleming Island", "state"=>"Florida", "status"=>"COMPLETED", "country"=>"United States", "facility"=>"Northeast Research Institute (NERI)", "geoPoint"=>{"lat"=>30.0933, "lon"=>-81.71898}}, {"zip"=>"34652", "city"=>"New Port Richey", "state"=>"Florida", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Suncoast Clinical Research, Inc.", "geoPoint"=>{"lat"=>28.24418, "lon"=>-82.71927}}, {"zip"=>"32803", "city"=>"Orlando", "state"=>"Florida", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Charter Research - Winter Park", "geoPoint"=>{"lat"=>28.53834, "lon"=>-81.37924}}, {"zip"=>"32162", "city"=>"The Villages", "state"=>"Florida", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Charter Research - Lady Lake", "geoPoint"=>{"lat"=>28.93408, "lon"=>-81.95994}}, {"zip"=>"96813", "city"=>"Honolulu", "state"=>"Hawaii", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Pacific Diabetes & Endocrine Center", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"83406", "city"=>"Ammon", "state"=>"Idaho", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Medical Research Partners", "geoPoint"=>{"lat"=>43.46964, "lon"=>-111.96664}}, {"zip"=>"60640", "city"=>"Chicago", "state"=>"Illinois", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Great Lakes Clinical Trials - Andersonville", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60640", "city"=>"Chicago", "state"=>"Illinois", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Great Lakes Clinical Trials - Ravenswood", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60077", "city"=>"Skokie", "state"=>"Illinois", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"NorthShore University Health System", "geoPoint"=>{"lat"=>42.03336, "lon"=>-87.73339}}, {"zip"=>"50265", "city"=>"West Des Moines", "state"=>"Iowa", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Iowa Diabetes and Endocrinology Research Center", "geoPoint"=>{"lat"=>41.57721, "lon"=>-93.71133}}, {"zip"=>"66606", "city"=>"Topeka", "state"=>"Kansas", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Cotton O'Neil Diabetes & Endocrinology", "geoPoint"=>{"lat"=>39.04833, "lon"=>-95.67804}}, {"zip"=>"40213", "city"=>"Louisville", "state"=>"Kentucky", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"L-MARC Research Center", "geoPoint"=>{"lat"=>38.25424, "lon"=>-85.75941}}, {"zip"=>"02492", "city"=>"Needham", "state"=>"Massachusetts", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Knownwell", "geoPoint"=>{"lat"=>42.28343, "lon"=>-71.23283}}, {"zip"=>"02740", "city"=>"New Bedford", "state"=>"Massachusetts", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Lucida Clinical Trials", "geoPoint"=>{"lat"=>41.63622, "lon"=>-70.93421}}, {"zip"=>"48034", "city"=>"Southfield", "state"=>"Michigan", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Headlands Research - Detroit", "geoPoint"=>{"lat"=>42.47337, "lon"=>-83.22187}}, {"zip"=>"48098", "city"=>"Troy", "state"=>"Michigan", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Arcturus Healthcare , PLC, Troy Internal Medicine Research Division", "geoPoint"=>{"lat"=>42.60559, "lon"=>-83.14993}}, {"zip"=>"63303", "city"=>"Saint Peters", "state"=>"Missouri", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"StudyMetrix Research", "geoPoint"=>{"lat"=>38.80033, "lon"=>-90.62651}}, {"zip"=>"89128", "city"=>"Las Vegas", "state"=>"Nevada", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Las Vegas Medical Research", "geoPoint"=>{"lat"=>36.17497, "lon"=>-115.13722}}, {"zip"=>"14226", "city"=>"Amherst", "state"=>"New York", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Dent Neurologic Institute", "geoPoint"=>{"lat"=>42.97839, "lon"=>-78.79976}}, {"zip"=>"13057", "city"=>"East Syracuse", "state"=>"New York", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Velocity Clinical Research, Syracuse", "geoPoint"=>{"lat"=>43.06534, "lon"=>-76.07853}}, {"zip"=>"11776", "city"=>"Port Jefferson Station", "state"=>"New York", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Warren Spinner", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"North Suffolk Neurology", "geoPoint"=>{"lat"=>40.92538, "lon"=>-73.04733}}, {"zip"=>"14609", "city"=>"Rochester", "state"=>"New York", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Rochester Clinical Research, LLC", "geoPoint"=>{"lat"=>43.15478, "lon"=>-77.61556}}, {"zip"=>"27405", "city"=>"Greensboro", "state"=>"North Carolina", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Medication Management", "geoPoint"=>{"lat"=>36.07264, "lon"=>-79.79198}}, {"zip"=>"28112", "city"=>"Monroe", "state"=>"North Carolina", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Monroe Biomedical Research", "geoPoint"=>{"lat"=>34.98543, "lon"=>-80.54951}}, {"zip"=>"28562", "city"=>"New Bern", "state"=>"North Carolina", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Lucas Research, Inc.", "geoPoint"=>{"lat"=>35.10849, "lon"=>-77.04411}}, {"zip"=>"45212", "city"=>"Cincinnati", "state"=>"Ohio", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"CTI Clinical Research Center", "geoPoint"=>{"lat"=>39.12713, "lon"=>-84.51435}}, {"zip"=>"29607", "city"=>"Greenville", "state"=>"South Carolina", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Tribe Clinical Research, LLC", "geoPoint"=>{"lat"=>34.85262, "lon"=>-82.39401}}, {"zip"=>"37211", "city"=>"Nashville", "state"=>"Tennessee", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Quality Medical Research", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"78745", "city"=>"Austin", "state"=>"Texas", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"IMA Clinical Research Austin", "geoPoint"=>{"lat"=>30.26715, "lon"=>-97.74306}}, {"zip"=>"75230", "city"=>"Dallas", "state"=>"Texas", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Velocity Clinical Research, Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"75231", "city"=>"Dallas", "state"=>"Texas", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"FutureSearch Trials of Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77079", "city"=>"Houston", "state"=>"Texas", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"PlanIt Research, PLLC", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"78229", "city"=>"San Antonio", "state"=>"Texas", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Tekton Research - Fredericksburg Road", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"zip"=>"78240", "city"=>"San Antonio", "state"=>"Texas", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Endeavor Clinical Trials", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"zip"=>"24541", "city"=>"Danville", "state"=>"Virginia", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Spectrum Medical, Inc.", "geoPoint"=>{"lat"=>36.58597, "lon"=>-79.39502}}, {"zip"=>"98801", "city"=>"Wenatchee", "state"=>"Washington", "status"=>"ACTIVE_NOT_RECRUITING", "country"=>"United States", "facility"=>"Association d/b/a Confluence Health", "geoPoint"=>{"lat"=>47.42346, "lon"=>-120.31035}}], "centralContacts"=>[{"name"=>"There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or", "role"=>"CONTACT", "email"=>"ClinicalTrials.gov@lilly.com", "phone"=>"1-317-615-4559"}], "overallOfficials"=>[{"name"=>"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Eli Lilly and Company"}]}, "ipdSharingStatementModule"=>{"url"=>"https://vivli.org/", "infoTypes"=>["STUDY_PROTOCOL", "SAP", "CSR"], "timeFrame"=>"Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.", "ipdSharing"=>"YES", "description"=>"Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.", "accessCriteria"=>"A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Eli Lilly and Company", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
