[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Immunwork, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},204,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Overweight and Obesity","NOT_YET_RECRUITING","2026-09-30",{"date":31,"type":32},"2026-10-05","ACTUAL",{"date":34,"type":21},"2026-10",{"date":36,"type":21},"2028-02",{"name":38,"class":39},"Immunwork, Inc.","INDUSTRY",2,""]