[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07652047":3,"trial-entities:NCT07652047":101,"trial-summary:NCT07652047":106},{"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":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":46,"secondary_outcomes":50,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":67,"locations":69,"central_contacts":95,"overall_officials":98,"references":99,"see_also_links":100},"NCT07652047","CX11102","A Study to Evaluate the Safety and Tolerability of Different Doses of CX11 Tablets","A Phase 1b Study Investigating Safety, Pharmacokinetics, and Pharmacodynamics of CX11 Tablets in Participants With Obesity or Overweight With Weight-Related Comorbidities","RECRUITING","2027-06","2026-06","2026-06-17","2026-05-11","Corxel Pharmaceuticals","INDUSTRY",false,"A multi-center, randomized, placebo-controlled, double-blinded (within cohorts), Sponsor-unblinded, Phase 1b study to explore the safety, pharmacokinetics, and pharmacodynamics of CX11 tablets in participants with obesity or overweight with weight-related comorbidities.",null,[19],"Obesity & Overweight",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},90,"ESTIMATED",[29,37,43],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","CX11","CX11 tablets administered orally once daily (QD) with meals",[34,35,36],"CX11 Group A","CX11 Group B","CX11 Group C",{"type":38,"name":39,"description":40,"armGroupLabels":41},"OTHER","Placebo","Matching placebo tablets administered orally once daily (QD) with meals",[42],"Placebo group",{"type":30,"name":31,"description":44,"armGroupLabels":45},"CX11 tablets administered orally once daily (QD) with high fat, high calorie meal",[34,35,36],[47],{"measure":48,"timeFrame":49},"Percentage change in body weight from baseline","Week 26",[],"FEMALE","18 Years","55 Years",{"inclusion":55,"exclusion":60,"raw_text":66},[56,57,58,59],"Male or female, 18-55 years.","BMI ≥30.0 to ≤39.9 kg\u002Fm², or ≥27.0 to \\\u003C30.0 kg\u002Fm² with at least 1 weight-related comorbidity: prediabetes, hypertension, dyslipidemia, or obstructive sleep apnea.","Prior unsuccessful diet\u002Fexercise weight-loss attempt and stable body weight within 90 days.","Able to comply with study procedures and reproductive requirements.",[61,62,63,64,65],"Diabetes or obesity due to endocrine\u002Fgenetic causes.","Recent weight-loss drugs, GLP-1-based therapy, glucose-lowering drugs, obesity surgery\u002Fdevice, or investigational treatment.","Significant cardiovascular, ECG\u002FQT, pancreatic, gallbladder, GI, liver, kidney, thyroid, psychiatric, malignant, infectious, autoimmune, or lab abnormality risks.","Personal\u002Ffamily history of medullary thyroid carcinoma or multiple endocrine neoplasia.","Pregnancy, breastfeeding, recent nicotine\u002Fdrug use, excessive alcohol use, or any condition\u002Fmedication making participation inappropriate.","Inclusion Criteria:\n\n* Male or female, 18-55 years.\n* BMI ≥30.0 to ≤39.9 kg\u002Fm², or ≥27.0 to \\\u003C30.0 kg\u002Fm² with at least 1 weight-related comorbidity: prediabetes, hypertension, dyslipidemia, or obstructive sleep apnea.\n* Prior unsuccessful diet\u002Fexercise weight-loss attempt and stable body weight within 90 days.\n* Able to comply with study procedures and reproductive requirements.\n\nExclusion Criteria:\n\n* Diabetes or obesity due to endocrine\u002Fgenetic causes.\n* Recent weight-loss drugs, GLP-1-based therapy, glucose-lowering drugs, obesity surgery\u002Fdevice, or investigational treatment.\n* Significant cardiovascular, ECG\u002FQT, pancreatic, gallbladder, GI, liver, kidney, thyroid, psychiatric, malignant, infectious, autoimmune, or lab abnormality risks.\n* Personal\u002Ffamily history of medullary thyroid carcinoma or multiple endocrine neoplasia.\n* Pregnancy, breastfeeding, recent nicotine\u002Fdrug use, excessive alcohol use, or any condition\u002Fmedication making participation inappropriate.",[68],"ADULT",[70,85],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":82},"Corxel Investigational site","Las Vegas","Nevada","89113","United States",[77],{"name":78,"role":79,"phone":80,"email":81},"Study Director","CONTACT","201-268-3723","information.center@corxelbio.com",{"lat":83,"lon":84},36.17497,-115.13722,{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":75,"contacts":90,"geoPoint":92},"Corxel Investigational Site","Austin","Texas","78744",[91],{"name":78,"role":79,"phone":80,"email":81},{"lat":93,"lon":94},30.26715,-97.74306,[96],{"name":97,"role":79,"phone":80,"email":81},"Study coordinator",[],[],[],{"nct_id":4,"conditions":102,"biomarkers":105},[103,104],"Obesity","Overweight",[],{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is a Phase 1b study that will include about 90 participants. It is randomized, meaning you will be assigned to a group by chance, and placebo-controlled, meaning some participants will receive an inactive pill (placebo) instead of CX11.","completed","CX11 for Obesity and Overweight","This study is testing different doses of CX11 tablets to see how safe they are and how well people tolerate them. You might be able to join if you are between 18 and 55 years old, and have obesity (BMI of 30.0 to 39.9 kg\u002Fm²) or are overweight (BMI of 27.0 to less than 30.0 kg\u002Fm²) with at least one weight-related health problem like prediabetes or high blood pressure. We're looking to see if CX11 helps with weight loss, specifically by measuring the percentage change in body weight after 26 weeks. The current recruitment status is unclear.","The main measurement for this study is taken at Week 26.",97,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]