[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Laekna Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100610662","phase-1-a-study-to-investigate-safety-tolerability-and-pharmacokinetics-of-lae103-or-lae103-in-combination-with-lae102-in-healthy-overweightobese-participants-100610662",false,"NCT07230496","A Study to Investigate Safety, Tolerability and Pharmacokinetics of LAE103 or LAE103 in Combination With LAE102 in Healthy Overweight\u002FObese Participants","A Phase I, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LAE103 as Single and Multiple Ascending Doses in Healthy Overweight\u002FObese Participants, and as Single Dose in Healthy Postmenopausal Women, With an Additional Evaluation of Single Ascending Dose of LAE103 in Combination With LAE102 in Healthy Overweight\u002FObese Participants","Inclusion Criteria:\n\n* Are capable of giving signed informed consent and comply with the requirements and restrictions listed in the ICF and in this protocol.\n* Male or female participants aged 18 to 55 years in part A, C, D. Female participants aged 45 to 75 years in Part B.\n* Have a BMI within the range of 25.0 to 40.0 kg\u002Fm2 in Parts A, C, and D and a BMI within the range of 20.0 to 35.0 kg\u002Fm2 in Part B.\n* Participants without childbearing potential or Participants with childbearing potential, non-pregnant, non-lactating, must agree to use two forms of effective methods of contraception (at least one form must be highly effective) .\n* Male participants with female partners of childbearing potential must agree to use adequate methods of contraception. Male subjects are not allowed to donate sperm during this trial.\n* Are overtly healthy participants or Have FSH levels ≥ 40 IU\u002FL at screening (Part B only).\n* Are willing to make themselves available for study visits for the duration of the study and are willing to follow study procedures.\n\nExclusion Criteria:\n\n* Have a history or presence of clinically significant medical condition(s).\n* Have a history of any malignancy within the past 5 years. other than basal cell or squamous epithelial carcinomas in situ and cervical carcinoma in situ that have been resected with no evidence of metastatic diseases for 3 years.\n* Have a fasting serum triglyceride level of more than 500 mg\u002FdL(5.6 mmol\u002FL) at screening.\n* Estimated glomerular filtration rate (eGFR) less than 90 mL\u002Fmin\u002F1.73 m2 at screening for Part A, C, and Part D or less than 60 mL\u002Fmin\u002F1.73 m2 at screening for Part B.\n* Have an abnormality in the 12-lead ECG to increase risk or QT (QTcF) interval greater than 450 msec at screening.\n* Have an abnormal blood pressure.\n* Positive human HIV antibodies or positive hepatitis C antibodies or positive hepatitis B surface antigen.\n* A history of, or known hypersensitivity to antibody drug, study procedure or any severe food or drug allergies.\n* Underwent major surgery within 30 days prior to study intervention administration or plan to undergo major surgery during the study.\n* Self-reported weight change is more than 5% in the previous 3 months prior to screening.\n* Engaged in regular weightlifting, fitness, or strength training aimed at enhancing muscle strength.\n* Use of GLP-1 receptor agonists, or weight loss medication within 3 months prior to the first dose of the investigational product.\n* Have used in the past 90 days (before screening) or intend to use during the study any medication that may affect FSH levels.\n* Have used or intend to use prescription or over the counter medications, or herbal medicines, from 14 days or 5 half-lives (if known), whichever is longer, prior to study intervention administration until the last visit.\n* Received any vaccine 30 days prior to screening or plan to receive any vaccine during the study.\n* Have participated, are currently enrolled in, or discontinued from a clinical trial involving an investigational drug or device or off-label use of a drug or device within the last 90 days, or 5-half-lives (if known, whichever is longer), of the last administration of study drug or application of the device, or any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Have previously completed or withdrawn from this study or any other study investigating this study intervention.\n* Have an average weekly alcohol consumption exceeding 14 units per week for female participants, 21 units per week for male participants, or positive alcohol test at screening or admission, or a history of alcohol abuse disorder within 1 year prior to screening, or an inability or unwillingness to stop alcohol consumption 7 days prior to dosing.\n* Have known or suspected history of substance abuse or test positive for drugs of abuse at screening or admission.\n* Are smoking more than 5 cigarettes (or the equivalent of other tobacco products) per day within 90 days prior to screening, or unable or unwilling to stop smoking tobacco products during the confinement period.\n* Have donated blood or experienced blood loss of more than 400 mL within 30 days prior to screening.\n* Are fasting or receiving weight loss treatment within 30 days prior to study intervention administration, or experiencing major changes in lifestyle.\n* In the opinion of the investigator or Sponsor and medical monitor, are unsuitable for inclusion in the study.\n* Are Laekna Limited. employees, CRO employees, investigator, or site personnel directly affiliated with this study or the immediate families of any of these. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.\n* Have contraindications for MRI scan or do not meet the requirements for MRI scan as per local guideline. (This criterion applies only to Parts C and D.)",true,"ALL","18 Years","75 Years",{"count":21,"type":22},104,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE103 injection in healthy overweight\u002Fobese participants or healthy postmenopausal women. Study will also evaluate the safety, tolerability and preliminary pharmacodynamic effect of multiple dose injections in overweight\u002Fobese participants.\n\nIn addition, the study will also investigate the safety, tolerability of a single-dose co-administration of LAE102 and LAE103 in healthy overweight\u002Fobese participants.",[28],"Overweight and Obesity","RECRUITING","2026-01-15",{"date":32,"type":33},"2026-01-20","ACTUAL",{"date":35,"type":33},"2025-12-30",{"date":37,"type":22},"2028-03-20",{"name":39,"class":40},"Laekna Limited","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":41},"100553976","phase-1-evaluate-lae102-in-healthy-and-overweightobese-subjects-100553976","NCT06493084","Evaluate LAE102 in Healthy and Overweight\u002FObese Subjects","A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LAE102 Injection in Healthy and Overweight\u002FObese Subjects","Inclusion Criteria:\n\n1. Male or female and aged 18 to 65 years (inclusive) at the screening visit\n2. Male Body weight ≥ 50 kg, female Body weight ≥ 45 kg. For Part A\\&B, 18.5 ≤ BMI ≤ 28 kg\u002Fm². For part C, 26.0 ≤ BMI ≤ 40.0 kg\u002Fm²\n3. Negative for human immunodeficiency virus antibody (HIV-Ab).\n4. Female subjects with no childbearing potential or with childbearing potential which serum human chorionic gonadotropin (hCG) test must \\\u003C5mIU\u002FmL .\n5. Male subjects are not allowed to donate sperm during this trial.\n6. Voluntarily participate in the study and provide a signed and dated informed consent form.\n7. Willing to comply with the scheduled visits, study treatment, laboratory tests, and other study-related procedures and requirements as stipulated in the study protocol.\n\nExclusion Criteria:\n\n1. With clinically significant abnormalities in vital signs, physical examination, ECG or laboratory test results specified in the protocol.\n2. Allergy to the investigational drug or its excipients, or a history of severe allergy (including any food or drug allergies).\n3. Self-reported weight change is more than 5% in the previous 3 months prior to screening.\n4. Diagnosed with secondary overweight or obesity.\n5. Any clinically significant medical conditions and any diseases affecting the safety of the subject or the determination of study results.\n6. History of major diseases or physical conditions in the central nervous system, respiratory system, cardiovascular system, digestive system, blood system, endocrine system, musculoskeletal diseases, mental illness, urinary system, or tumors, or any existing acute diseases, or other diseases or physical conditions that may affect the study or pose an unacceptable risk to the subjects.\n7. Positive for hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV-Ab), or syphilis spirochete antibody (TP-Ab).\n8. Known or suspected history of substance abuse or positive drug screening test.\n9. Alcohol abuse within 1 year before screening or positive alcohol breath test at baseline.\n10. Smoking more than 5 cigarettes per day within 3 months before screening, or unable to comply with the prohibition of smoking during the study period.\n11. Received any vaccine within 30 days prior to screening, or planned to receive any vaccine during the study period.\n12. Inability to ensure no use of any drugs, including prescription and non-prescription drugs (excluding paracetamol, ibuprofen, and topically applied eye\u002Fnasal drops and ointments with no systemic exposure risk), vitamins, supplements and herbal medicines, from 14 days before the initial administration (if the half-life of the drug used exceeds 14 days, then 5 half-lives shall apply) until the last visit period.\n13. Participated in any clinical trial and received an investigational medicine or medical device within 3 months prior to dosing of the investigational product.\n14. Underwent major surgery within 30 days before the initial administration or planned to undergo major surgery during the study period.\n15. Donated blood or experienced blood loss ≥400 mL within 3 months before screening or received a blood transfusion.\n16. Have special dietary requirements and cannot comply with a standardized diet.\n17. History of fainting or syncope.\n18. Dieting or receiving weight loss treatment within 30 days before the initial administration or experiencing major changes in lifestyle.\n19. Use of GLP-1 receptor agonists, or weight loss medications or systemic corticosteroids (oral or intravenous for more than 7 days), or psychiatric medications within 3 months prior to the initial administration. Applicable to part C.\n20. Regular engaged in muscle strength related exercise, applicable to part C.\n21. Other situation that the investigator considers not appropriate.","65 Years",{"count":51,"type":22},160,[25],"The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight\u002Fobese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight\u002Fobese participants.",[55],"Overweight and Obese Volunteers","2026-01-07",{"date":58,"type":33},"2026-01-09",{"date":60,"type":33},"2024-06-25",{"date":62,"type":22},"2026-09-30",{"name":39,"class":40},""]