[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07707375":3,"trial-entities:NCT07707375":94,"trial-summary:NCT07707375":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":10,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":60,"locations":63,"central_contacts":80,"overall_officials":88,"references":92,"see_also_links":93},"NCT07707375","27850","A Study of LY4268989 (MORF 057) in Healthy Participants","A Phase 1 Study to Investigate the Pharmacokinetics, Safety and Tolerability of LY4268989 (MORF-057) in Healthy Participants","NOT_YET_RECRUITING","2026-10","2026-07","2026-07-16","Eli Lilly and Company","INDUSTRY",false,"The purpose of this study is to identify if two different tablets of LY4268989 (MORF 057) work similarly in healthy participants given different meals.\n\nBlood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.\n\nThere will be 18 inpatient stays at the clinical research unit (CRU). The study will last about 9 weeks.",null,[18],"Healthy",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"PHASE1",{"count":25,"type":26},50,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","LY4268989","Administered orally",[33,34,35,36,37,38],"LY4268989 Treatment A","LY4268989 Treatment B","LY4268989 Treatment C","LY4268989 Treatment D","LY4268989 Treatment E","LY4268989 Treatment F",[40,43],{"measure":41,"timeFrame":42},"Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4268989","Day 1 to Day 18",{"measure":44,"timeFrame":42},"PK: Area Under the Concentration Curve (AUC) of LY4268989",[],"ALL","18 Years","65 Years",true,{"inclusion":51,"exclusion":54,"raw_text":59},[52,53],"Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory test, electrocardiograms (ECGs), and vital signs.","Have a body mass index (BMI) within the range 18.0 to 32.0 kilogram\u002Fsquare meter (kg\u002Fm²), inclusive, at screening.",[55,56,57,58],"Have a current or recent acute, active infection. For at least 30 days before screening and up to Day 1, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment.","Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disorders, or abnormal laboratory values at screening that, in the opinion of the sponsor or investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data.","Are immunocompromised to an extent that participation in the study would pose an unacceptable risk to the participant as determined by the investigator.","Use or intend to use prescription or nonprescription medication, including dietary supplements, vitamins, herbal supplements, traditional Chinese medicine, alternative medicines, or any medication known to be moderate to strong cytochrome P450 3A4 (CYP3A) inhibitors or inducers, or organic anion transporting polypeptide 1B1 (OATP1B) inhibitors, P-gp inhibitors, or medications that are narrow therapeutic index substrates for breast cancer resistance protein (BCRP) or P-gp within 14 days or 5 half lives, whichever is longer, prior to dosing, until the end of study assessments are complete.","Inclusion Criteria:\n\n* Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory test, electrocardiograms (ECGs), and vital signs.\n* Have a body mass index (BMI) within the range 18.0 to 32.0 kilogram\u002Fsquare meter (kg\u002Fm²), inclusive, at screening.\n\nExclusion Criteria:\n\n* Have a current or recent acute, active infection. For at least 30 days before screening and up to Day 1, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment.\n* Have presence of significant uncontrolled respiratory, cerebrocardiovascular, cardiovascular, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or psychiatric disorders, or abnormal laboratory values at screening that, in the opinion of the sponsor or investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data.\n* Are immunocompromised to an extent that participation in the study would pose an unacceptable risk to the participant as determined by the investigator.\n* Use or intend to use prescription or nonprescription medication, including dietary supplements, vitamins, herbal supplements, traditional Chinese medicine, alternative medicines, or any medication known to be moderate to strong cytochrome P450 3A4 (CYP3A) inhibitors or inducers, or organic anion transporting polypeptide 1B1 (OATP1B) inhibitors, P-gp inhibitors, or medications that are narrow therapeutic index substrates for breast cancer resistance protein (BCRP) or P-gp within 14 days or 5 half lives, whichever is longer, prior to dosing, until the end of study assessments are complete.",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":77},"Fortrea Clinical Research Unit","Daytona Beach","Florida","32117","United States",[71,74],{"role":72,"phone":73},"CONTACT","386-366-6400",{"name":75,"role":76},"Hugh Coleman","PRINCIPAL_INVESTIGATOR",{"lat":78,"lon":79},29.21081,-81.02283,[81,85],{"name":82,"role":72,"phone":83,"email":84},"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","1-317-615-4559","LillyTrials@Lilly.com",{"name":86,"role":72,"email":87},"Physicians interested in becoming principal investigators please contact","clinical_inquiry_hub@lilly.com",[89],{"name":90,"affiliation":12,"role":91},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":96},[18],[],{"nct_id":4,"found":49,"summary":98,"prompt_version":107},{"design":99,"status":100,"heading":6,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is an interventional study with a planned enrollment of 50 healthy participants. The specific phase of the study is not provided.","completed","This study is looking for healthy volunteers, aged 18 to 65, to help understand how the body processes two different forms of an oral drug called LY4268989 (MORF 057). Researchers want to see if these two forms work similarly when taken with different meals. You would need to be generally healthy with a body mass index (BMI) between 18.0 and 32.0. The main goal is to measure how much of LY4268989 is in your blood over time (pharmacokinetics or PK), specifically the highest concentration (Cmax) and the total amount (AUC) from Day 1 to Day 18. The study involves 18 overnight stays at a clinical research unit and lasts about 9 weeks.","The primary measurements for the drug in your body (pharmacokinetics) will be taken from Day 1 to Day 18.",112,"You would have 18 overnight stays at a clinical research unit (CRU) over approximately 9 weeks. Blood tests will be performed to check how your body processes the drug.","Not stated in the trial record.",[30],"v2"]