[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658824":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":26,"studyPopulation":11,"armGroups":27,"interventions":57,"overallOfficials":11,"centralContacts":72,"locations":79,"responsibleParty":102,"collaborators":11,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":11,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":113,"enrollmentInfo":114,"targetDuration":11,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":11,"overallStatus":123,"whyStopped":11,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Immunwork, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of treatment-emergent adverse events, including treatment-related adverse events.",null,"up to 31 weeks after 1st dosing",{"measure":14,"description":15,"timeFrame":12},"Changes from baseline in clinical laboratory assessments, physical examination findings, vital signs, and electrocardiogram (ECG) values.","Laboratory assessments include hematology, clinical chemistry, coagulation, and urinalysis. The following 12-lead ECG parameters will be analyzed: ventricular HR, PR interval, QRS duration, QT interval, and QTcF.",{"allocation":17,"interventionModel":18,"interventionModelDescription":11,"primaryPurpose":19,"observationalModel":11,"timePerspective":11,"maskingInfo":20},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":21,"maskingDescription":11,"whoMasked":22},"TRIPLE",[23,24,25],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","TE-8105 is an injectable glucagon-like peptide-1 (GLP-1) receptor agonist designed to help manage body weight and blood sugar levels. Researchers will test different dose levels of TE-8105 compared to a placebo (an inactive substance that looks like the study drug) to find out how well TE-8105 works, how safe it is, and how the body absorbs and processes the drug over time.\n\nA total of up to 204 eligible participants will be enrolled across 3 sequential dose-escalation cohorts (up to 68 participants per cohort). Within each cohort, participants will be randomly assigned in a 3:1 ratio to receive either TE-8105 or a matching placebo as a subcutaneous injection over a 25-week period.\n\nAn independent Safety Review Committee (SRC) will review blinded safety and PK data before approving dose escalations between cohorts and titration steps within cohorts.\n\nA subset of participants (12 per cohort: 10 receiving TE-8105 and 2 receiving placebo) will participate in intensive PK blood sampling to evaluate how the drug is processed in the body over time.\n\nAll participants will undergo regular safety monitoring, including physical examinations, vital sign measurements, laboratory testing, 12-lead ECGs, monitoring for side effects (particularly gastrointestinal side effects), and assessments of body weight, waist and hip circumferences, body composition, and blood sugar and lipid levels.",[28,34,40,45,49,53],{"label":29,"type":30,"description":31,"interventionNames":32},"Cohort 1 TE-8105","EXPERIMENTAL","Administered via subcutaneous (SC) injection according to the following step-up schedule:\n\nWeeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks.",[33],"Drug: TE-8105 MAD Cohort 1",{"label":35,"type":36,"description":37,"interventionNames":38},"Cohort 1 Placebo","PLACEBO_COMPARATOR","Administered via SC injection matching the Cohort 1 dosing schedule (Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks).",[39],"Drug: Placebo",{"label":41,"type":30,"description":42,"interventionNames":43},"Cohort 2 TE-8105","Administered via SC injection according to the following step-up schedule:\n\nWeeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks.",[44],"Drug: TE-8105 MAD Cohort 2",{"label":46,"type":36,"description":47,"interventionNames":48},"Cohort 2 Placebo","Administered via SC injection matching the Cohort 2 dosing schedule (Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks).",[39],{"label":50,"type":30,"description":42,"interventionNames":51},"Cohort 3 TE-8105",[52],"Drug: TE-8105 MAD Cohort 3",{"label":54,"type":36,"description":55,"interventionNames":56},"Cohort 3 Placebo","Administered via SC injection matching the Cohort 3 dosing schedule (Weeks 1-8 once weekly, Week 9 rest, Weeks 10-24 every 2 weeks).",[39],[58,63,66,69],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":11},"DRUG","TE-8105 MAD Cohort 1","Administered via SC injection.",[29],{"type":59,"name":64,"description":61,"armGroupLabels":65,"otherNames":11},"TE-8105 MAD Cohort 2",[41],{"type":59,"name":67,"description":61,"armGroupLabels":68,"otherNames":11},"TE-8105 MAD Cohort 3",[50],{"type":59,"name":70,"description":61,"armGroupLabels":71,"otherNames":11},"Placebo",[35,46,54],[73],{"name":74,"role":75,"phone":76,"phoneExt":77,"email":78},"Ya-Shan Chuang, PhD","CONTACT","+886-2-2651-2268","512","yashan.chuang@immunwork.com",[80,93],{"facility":81,"status":11,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":11},"Canopy Clinical Inner West","Leichhardt","New South Wales","2040","Australia","AU",{"type":88,"coordinates":89},"Point",[90,91],151.15625,-33.88341,{"lat":91,"lon":90},{"facility":94,"status":11,"city":95,"state":83,"zip":96,"country":85,"countryCode":86,"cosmosGeoPoint":97,"geoPoint":101,"contacts":11},"Canopy Clinical Western Sydney","Penrith","2750",{"type":88,"coordinates":98},[99,100],150.7,-33.75,{"lat":100,"lon":99},{"type":103,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658824","phase-2-a-study-to-investigate-the-safety-and-efficacy-of-te-8105-in-overweight-or-obesity-participants-100658824",false,"NCT07857473","A Study to Investigate the Safety and Efficacy of TE-8105 in Overweight or Obesity Participants","A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study to Investigate the Safety and Efficacy of TE-8105 Administered Subcutaneously in Participants With Overweight or Obesity","Inclusion Criteria:\n\n* Able to understand the full nature, purpose, and risks of the study and provide written informed consent before starting study procedures.\n* Body Mass Index (BMI) ≥25 and ≤34.9 kg\u002Fm², OR\n* BMI ≥25 and ≤34.9 kg\u002Fm² with at least one weight-related condition: high blood pressure (hypertension), high cholesterol or triglycerides (dyslipidemia), cardiovascular disease, or type 2 diabetes mellitus.\n* Stable body weight (less than 5% change in weight in either direction) during the screening period.\n* Medically healthy overall (apart from overweight or obesity) as determined by medical history, physical examination, vital signs, ECG, and routine laboratory tests without clinically significant abnormalities.\n* Female participants:\n\nMust be unable to become pregnant (postmenopausal for at least 12 months or surgically sterilized at least 6 weeks prior to screening), OR\n\nIf able to become pregnant: must have negative pregnancy tests at screening and before randomization, agree not to attempt pregnancy or donate eggs, and agree to use a condom combined with a highly effective method of birth control from consent until at least 60 days after the last study dose (unless practicing complete abstinence or in a same-sex relationship).\n\n* Male participants:\n\nMust agree not to donate sperm from consent until at least 120 days after the last study dose.\n\nIf sexually active with a female partner who can become pregnant, must agree to use a condom combined with highly effective birth control until at least 120 days after the last study dose.\n\nIf sexually active with a female partner who cannot become pregnant or a same-sex partner, must agree to use a condom until at least 30 days after the last study dose.\n\n* Have suitable veins for routine blood draws.\n\nExclusion Criteria:\n\n* An abnormal clinical laboratory test value specified in the protocol.\n* Previous weight-loss surgery or procedures (e.g., gastric bypass, sleeve gastrectomy, gastric balloon, or intestinal sleeve) within 6 months prior to screening, or planned during the study.\n* Participation in organized weight-loss programs (e.g., WeightWatchers, Jenny Craig) or meal replacement plans within 30 days prior to screening or planned during the study.\n* Self-reported weight change of more than 5% in the 6 months prior to randomization or more than 10% in the 12 months prior to screening.\n* Exposure to any GLP-1 receptor agonist medications within 3 months prior to screening, history of allergic reactions to GLP-1 medications, or lingering effects\u002Frebound weight gain from past GLP-1 treatments.\n* Use of prescription or over-the-counter medications intended to promote weight loss or that cause weight gain within 3 months prior to randomization.\n* Use of any diabetes medication other than metformin (e.g., insulin use is excluded).\n* Diagnosis of Type 1 diabetes, history of diabetic ketoacidosis, or hyperosmolar coma.\n* Obesity caused by other hormonal disorders (e.g., Cushing syndrome) or rare genetic conditions (e.g., Prader-Willi syndrome).\n* History or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN 2).\n* Uncontrolled thyroid disease, unless on a stable thyroid replacement dose for at least 3 months, or subclinical thyroid conditions that may require new treatment during the study.\n* Severe kidney impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or creatinine clearance \\\u003C60 mL\u002Fmin).\n* Significant liver disease, acute\u002Fchronic hepatitis, elevated liver enzymes (ALT \\> 3.0x upper limit of normal, ALP \\>1.5x upper limit of normal, or bilirubin \\>1.2x upper limit of normal), or fasting triglycerides \\> 500 mg\u002FdL.\n* History of chronic pancreatitis or unexplained acute pancreatitis.\n* Gastrointestinal disorders (such as severe acid reflux or delayed stomach emptying) that could interfere with drug absorption or study participation.\n* Severe or uncontrolled heart conditions within 3 months prior to randomization (e.g., heart attack, stroke, unstable angina, or heart failure hospitalization), or Class IV severe heart failure.\n* History of irregular heart rhythms or risk factors for long QT syndrome (Torsade de Pointes).\n* Active cancer or history of cancer within the last 10 years (except fully removed non-melanoma skin cancer).\n* Positive screening test for HIV, Hepatitis B, or Hepatitis C.\n* Active infection requiring systemically absorbed antibiotics, antivirals, or antifungals within 10 days before the first dose.\n* Active or unstable major depression or severe psychiatric disorders (such as schizophrenia or bipolar disorder) within the past 2 years. (Participants with stable depression or generalized anxiety on stable treatment may be eligible).\n* Any lifetime history of suicide attempts, or active suicidal thoughts\u002Fself-harm ideation within 2 weeks prior to or during screening.\n* History of alcohol abuse within 1 year, or regular consumption of more than 2 standard drinks per day (14 drinks per week).\n* Positive drug screen for drugs of abuse or positive alcohol breath test at screening or before the first dose.\n* Heavy smoking or nicotine use (≥6 cigarettes, cigars, vapes, or nicotine equivalents per day).\n* Unwillingness to refrain from starting new intense exercise programs (including weightlifting) from 7 days prior to Day 1 through 28 days after the final dose.\n* Unwillingness to follow dietitian advice, maintain study diaries, or refrain from using prohibited medications.\n* Females who are pregnant, breastfeeding, or planning to breastfeed.\n* Skin conditions (such as severe sunburn, deep scar tissue, large tattoos, or open sores) at potential injection sites that would interfere with dosing or site assessments.\n* Blood or plasma donation within 30 days, major blood loss (\\>500 mL) within 30 days, or blood transfusion within 1 year prior to first dose.\n* Participation in another clinical trial testing an investigational drug or device within 30 days prior to screening.\n* Any active, serious medical condition with an estimated life expectancy of less than 2 years, or any condition that in the investigator's judgment makes participation unsafe or non-compliance likely.","ALL","18 Years","65 Years",{"count":115,"type":116},204,"ESTIMATED","INTERVENTIONAL",[119],"PHASE2","This is a Phase 2b, randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of TE-8105 in adults with overweight or obesity, with or without weight-related health conditions.\n\nParticipants in this study will receive subcutaneous (under the skin) injections of either TE-8105 or placebo for 25 weeks. The total study duration, including screening and follow-up visits, is approximately 8 months.",[122],"Overweight and Obesity","NOT_YET_RECRUITING","2026-09-30",{"date":126,"type":127},"2026-10-05","ACTUAL",{"date":129,"type":116},"2026-10",{"date":131,"type":116},"2028-02",{"name":5,"class":6},2]