[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"submental-fullness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:submental-fullness":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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},"100645194","phase-2-stp705-injection-for-submental-fat-reduction-100645194",false,"NCT07677683","STP705 Injection for Submental Fat Reduction","A Phase 2 Study of STP705 Injection for Submental Fat Reduction","Inclusion Criteria:\n\n* Aged 18 to 65 years of age, inclusive, at the time of Screening.\n* Body mass index of ≤ 40.0 kg\u002Fm2.\n* Good general health, in the opinion of the Investigator or designee, with no clinically significant medical history, and have no clinically significant abnormalities on physical examination, electrocardiogram (ECGs), or laboratory assessments at Screening and\u002For before the first administration of the IP.\n* Grade 2 or 3 Submental fat, as assessed by the Investigator using the Clinician-Reported-Submental Fat Rating Scale (CR-SMFRS) AND as assessed by the participant using the Participant-Reported- Submental Fat Rating Scale (PR-SMFRS).\n* Dissatisfaction with the submental area, as assessed by the participant as a rating of 0, 1, or 2 using the Participant-Self Satisfaction Scale (PSSS).\n* History of stable body weight for at least 6 months (+\u002F- 5 kg) prior to first dosing with the IP.\n* Woman of childbearing potential (WOCBP) or fertile man agrees to use an acceptable method of contraception from the start of Screening until 90 days after the last dose of IP. Acceptable methods of contraception are defined in .\n* Agrees to refrain from making significant changes, in the judgement of the Investigator, to dietary or exercise habits during the study.\n* Agrees to forego any treatment or behaviour (eg, unshaven facial hair) during the participation inthe study that may affect the assessments of the submental area.\n* No clinically significant abnormalities at Screening on clinical and laboratory tests, at the discretion of the Investigator.\n* Able and willing to attend the necessary visits to the study site.\n* Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.\n\nExclusion Criteria:\n\n* History of any intervention to treat Submental fat (eg, liposuction, surgery, or lipolytic agents).\n* Treatment with botulinum toxin injections in the neck or chin area within 6 months prior to the first dosing with the IP through the end of study (EOS).\n* History of trauma associated with the chin or neck areas that in the judgement of the Investigator may affect evaluation of safety or efficacy of treatment.\n* Evidence of any cause of enlargement in the submental area (eg, thyroid enlargement, cervical adenopathy) other than localised Submental fat.\n* A Submental Skin Laxity Grade (SMSLG) of 4 or other anatomical feature (eg, predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands), as assessed within 28 days prior to the first dosing with the IP, for which reduction in Submental fat may, in the judgement of the Investigator, result in an aesthetically unacceptable outcome.\n* Treatment with radio frequency, laser procedures, ultrasound, chemical peels, or dermal fillers in the neck or chin area within 12 months prior to first dosing with the IP and through the end of study(EOS).\n* History or current symptoms of dysphagia. 8. Any medical condition (eg, respiratory, cardiovascular, hepatic, neurological disease, or thyroid dysfunction) that (in the opinion of the Investigator) would interfere with assessment of safety or efficacy or compromise the participant's ability to undergo study procedures or give informed consent.\n* History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents.\n* Treatment with an investigational device or agent within 30 days prior to the first dosing with the IP and through the end of study(EOS).\n* Blood or plasma donation or had significant blood loss (\\> 500 mL) within 30 days prior to the first dosing with the IP.\n* History of severe Type I-IV hypersensitivity reactions.\n* History of cytokine release syndrome (CRS).\n* History of marginal mandibular nerve injury.\n* History or current lower facial weakness and\u002For lower facial asymmetry.\n* Pregnancy, breastfeeding, or planning to breastfeed during the study and for at least 90 days (approximately 5 half-lives of the study drug) after the last dose of study treatment.\n* Unwillingness to use medically acceptable methods of contraception during the study and for at least 90 days after the last dose of study treatment.\n* Presence of genetic or endocrine disorders associated with obesity that are not amenable to submental fat reduction, including but not limited to Cohen syndrome, Alström syndrome, Prader-Willi syndrome, untreated hypothyroidism, Cushing's syndrome, or lipodystrophy syndromes.\n* Active dermatitis, open wounds, or infection in the treatment area.\n* Medical conditions affecting platelet function or coagulation.\n* Use of medications that affect coagulation or platelet function within 14 days prior to the first dosing of the IP, or unwillingness to abstain from such medications through the end of study(EOS).\n* Use of tanning beds and\u002For excessive sun exposure within 14 days prior to the first dosing of the IP, or unwillingness to abstain from these during the study through the end of study(EOS).","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This Phase 2 study aims to assess the efficacy of SC injections of STP705 for the reduction of Submental fat in apopulation of healthy adult volunteers, and to further establish its safety and tolerability.\n\nThe primary objective is to evaluate the efficacy of STP705 injection for Submental fat reduction. The second objective is to evaluate the safety and tolerability of STP705 injection.\n\nThis is an open-label study. Eligible participants will be sequentially enrolled into 1 of 3 treatment cohorts, as follows:\n\nCohort 1: 40 µg STP705 per injection. Up to 280 µg in total (n = 10 participants) Cohort 2: 64 µg STP705 per injection. Up to 448 µg in total (n = 10 participants) Cohort 3: 80 µg STP705 per injection. Up to 560 µg in total (n = 10 participants)\n\nThe STP705 powder will be reconstituted with dextrose 5% in water (D5W). A total of 7 injections (3.5 mL total volume) in a single treatment may be administered to each participant in the submental triangle area (ie, for a total dose of up to 280 µg, 448 µg or 560 µg STP705 for each cohort). The Submental fat injections will be performed at Day 1\u002FBaseline, Day 29, and Day 57 , pending favourable reviews by the Investigator of injection site reactions (ISRs), local skin reactions (LSRs), and participant assessments of the injection sites (pain, stinging, and burning). To proceed with treatment at Day 29 or Day 57, the following factors will be considered:\n\n1. the total tolerability score per injection site (defined as the sum of the \"Investigator assessed LSRscores\" and the \"participant-reported scores of injection site pain and stinging\u002Fburning\" measured prior totreatment must be \\\u003C 6, and\n2. there are no findings (eg, systemic and\u002For local adverse events \\[AEs\\]) that would preclude treatment, in the opinion of the Investigator. The tolerability score threshold should be interpreted in conjunction with clinical judgment. If condition a) is not met, participants with a total tolerability score = 6 will not be injected with the study medications. After the 3rd injection, the participant will be followed for 1 month (through to Day 85). To proceed with dose escalation (ie, from Cohort 1 to Cohort 2 or from Cohort 2 to Cohort 3), the last participant in the previous dose cohort must have completed at least 7 days of postdose safety follow-up after the first injection, and available safety data will be reviewed by the Sponsor and Medical Monitor. The decision to escalate dose will be made upon review of all data by the Medical Monitor and the Sponsor and recommendation by the Sponsor.",[27],"Submental Fullness","NOT_YET_RECRUITING","2026-06-24",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":21},"2026-07-16",{"date":36,"type":21},"2027-09-25",{"name":38,"class":39},"Sirnaomics","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":5},"100611195","phase-1-intralesional-ronkyla-plus-injection-for-the-treatment-of-superficial-lipoma-100611195","NCT07237425","Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma","A Safety, Efficacy and Pharmacokinetic Evaluation Study of Intralesional Ronkyla Plus Injection for the Treatment of Superficial Lipoma","Inclusion Criteria:\n\n1. Healthy male or female adults aged 18 to 65 years, inclusive.\n2. One or more superficial lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:\n\n   * History of slow growth followed by dormancy, and stable for at least 6 months.\n   * Greatest length by greatest perpendicular width between 1 and 10 square centimeters, inclusive.\n   * Discrete, oval to rounded in shape, not hard or attached to underlying tissue.\n   * Located on the trunk, arms, legs, or neck\n   * Needle biopsy core tissue sample histological analysis results consistent with a diagnosis of lipoma.\n\n   OR, sufficient submental fat for injection of 100 mg Kybella in the judgment of the investigator (Part II Kybella cohort only)\n3. Body mass index (BMI): BMI between 22 to 30 (normal, overweight and slight obese).\n4. History of stable body weight, in the judgment of the investigator, for at least 6 months before enrollment.\n5. The health status is assessed by the investigator as \"normal healthy\" based on required screening assessments.\n6. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before enrollment and agree to use a highly effective method of contraception from enrollment up to the study end, such as:\n\n   * Intrauterine device\n   * Combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation (oral, intravaginal, or transdermal)\n   * Progestogen-only hormonal contraception associated with the inhibition of ovulation (oral, injectable, intrauterine, or implantable)\n   * Tubal ligation\n   * Vasectomized male partner\n   * Sexual abstinence\n\n   Female subject being postmenopausal for at least 1 year or surgically sterile is considered to be of no childbearing potential.\n7. Able and willing to comply with scheduled clinic visits and clinical trial procedures.\n8. Capable of understanding and giving signed informed consent form after full discussion of the research nature of the treatment and its risk and benefits with the investigator\u002F designee of the sponsor.\n\nExclusion Criteria:\n\n1. History of surgical treatment for the target superficial lipoma or submental area (Part II Kybella cohort only).\n2. Current infection or wound near the target superficial lipoma or the submental area (Part II Kybella cohort only).\n3. History of diabetes.\n4. Allergic to excipients of Ronkyla Plus or Kybella (Part II Kybella cohort only)\n5. A result on coagulation tests (prothrombin time, activated partial thromboplastin time) obtained within 28 days before enrollment that indicates the presence of any clinically significant bleeding disorder (subjects being treated with antiplatelet therapy or anticoagulants could be enrolled after 7-day washout period):\n\n   * Prothrombin time \\> 20 seconds.\n   * Activated partial thromboplastin time \\> 60 seconds.\n   * INR \\> 3.\n6. Any ongoing medical condition with significant risk of bleeding\n7. Evidence of any serious active infections, COVID 19, severe uncontrolled cardiac, renal, hepatic, pulmonary or other systemic disease, significant medical or psychiatric condition, known seropositivity to HIV\u002FHBV\u002FHCV, or clinically significant laboratory findings that would, in the investigator's judgment, make the subject inappropriate for the study.\n8. Administration of an investigational drug within 30 days prior to enrollment.\n9. Administration of a COVID-19 vaccine within 30 days prior to enrollment.\n10. Abnormal hepatic and renal functions; hematologic changes at screening:\n\n    * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 X upper limit of normal (ULN).\n    * Total bilirubin \\> 1.5 X ULN.\n    * Serum creatinine \\> 1.5 X ULN.\n    * Hemoglobin \\\u003C lower limit of normal (LLN).\n    * Platelets ≤ 100.000\u002Fmm³.\n11. Current malignancy of any organ system or a history within 5 years.\n12. Subjects who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.\n\nPart I \\& Part II Ronkyla Plus cohort specific exclusion criteria:\n\n1. History of any medical condition contraindicated or not recommended for aspirin use including active peptic ulcer disease, asthma, gout, uncontrolled hypertension.\n2. Taking any medication contraindicated or not recommended for concomitant use with aspirin within 7 days prior to enrollment.\n3. Allergic to Aspirin, salicylates, or non-steroidal anti-inflammatory drugs (NSAIDs).\n4. The target lipoma warrants surgical removal per the investigator's judgement (e.g., for confirming its pathology).\n\nPart I dose level 2 and 4 cohorts \\& Part II specific exclusion criteria:\n\n1. History of alcohol or drug abuse within the past year prior to Day 1.\n2. History of smoking or use of nicotine-containing product within 6 months prior to Day 1.\n3. Donation or significant loss of blood (480 mL or more) within 60 days prior to Day 1.",true,{"count":50,"type":21},56,[52],"PHASE1","This study aims to evaluate the safety, efficacy, and pharmacokinetics of Ronkyla Plus, a combinational drug that forms a hydrogel at the injection site, promising a better experience of lipolysis injection for the treatment of superficial lipoma. The study consists of a Part I dose-escalation study to investigate the drug's maximum tolerated dose (MTD) for this indication and a Part II study for evaluating its relative bioavailability in comparison to an FDA-approved lipolysis injection, Kybella.",[55,27],"Lipoma",[57,58],"ATX-101","Ronkyla Plus","RECRUITING","2025-11-26",{"date":62,"type":32},"2025-12-04",{"date":64,"type":32},"2025-11-14",{"date":66,"type":21},"2027-01-14",{"name":68,"class":39},"Glonova Pharma Co., Ltd"]