[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07724340":3,"trial-entities:NCT07724340":213,"trial-summary:NCT07724340":219},{"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":44,"secondary_outcomes":49,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":15,"eligibility_criteria":81,"std_ages":85,"locations":88,"central_contacts":209,"overall_officials":210,"references":211,"see_also_links":212},"NCT07724340","AT673-OB-200","A Study to Assess the Efficacy, Safety and Tolerability of AT673 Co-administered With Semaglutide in Adult Participants With Type 2 Diabetes (T2D) and Overweight or Obesity","A Phase 2, Randomized, Double-blind, Placebo-Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of AT673 Co-administered With Semaglutide in Adult Participants With Type 2 Diabetes (T2D) and Overweight or Obesity","RECRUITING","2027-03","2026-07","2026-07-24","2026-06-19","Antag Therapeutics","INDUSTRY",false,"The goal of this clinical trial is to learn if AT673 contributes to additional weight loss and glycemic control when given with semaglutide in participants with overweight\u002Fobesity and type 2 diabetes. The main questions it aims to answer are:\n\n* To compare the effect on body weight of two doses of AT673 once-weekly versus matched placebo when concurrently administered with semaglutide once-weekly\n* To evaluate the effect of AT673 on glycated hemoglobin (HbA1c)\n* To compare the safety and tolerability of AT673 versus matched placebo when concurrently administered with semaglutide","This is a phase 2, double-blind, placebo-controlled study. Following screening, at their baseline visit, participants will initiate treatment with semaglutide at 0.25 mg\u002Fweek and follow the product labelled dose escalation schedule until reaching the dose of 1.0 mg\u002Fweek. Participants will remain on this dose until the end of study (EOS) visit.\n\nAt the baseline visit, participants will be randomized in a 1:1:1 ratio to receive AT673 25 mg, or 50 mg, or matching placebo, respectively, once weekly at the same time as semaglutide.\n\nParticipants will receive AT673 \u002F placebo injections concurrently with Semaglutide during weekly clinic visits. Treatment with the AT673 \u002F placebo will continue through the end of 13 weeks. This will be followed by a 4-week safety follow-up. The end of study visit will be at week 17.",[19],"Adults With Overweight\u002FObesity and Type 2 Diabetes",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},150,"ESTIMATED",[29,35,40],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","AT673 low dose","low dose",[34],"Low dose",{"type":30,"name":36,"description":37,"armGroupLabels":38},"AT673 high dose","high dose",[39],"High dose",{"type":30,"name":41,"description":42,"armGroupLabels":43},"Placebo","matching placebo",[41],[45],{"measure":46,"description":47,"timeFrame":48},"Body weight","Percent change in body weight from baseline to week 13","13 weeks",[50,53,56,60,62,64,66,68,70,72,74,76],{"measure":51,"description":52,"timeFrame":48},"HbA1c","Absolute change from baseline to week 13 in blood concentration of HbA1c (%, mmol\u002Fmol)",{"measure":54,"description":55,"timeFrame":48},"Safety and Tolerability","Frequency, severity and seriousness of treatment emergent AEs",{"measure":57,"description":58,"timeFrame":59},"Achieving clinically significant body weight loss from baseline to week 13","Proportion of participants achieving \\>5%, and \\>10% body weight loss from baseline to week 13","week 13",{"measure":61,"timeFrame":48},"Assess treatment effect on Body Mass Index",{"measure":63,"timeFrame":48},"Assess the treatment effect on insulin",{"measure":65,"timeFrame":48},"Assess the treatment effect on blood pressure",{"measure":67,"timeFrame":48},"Assess the treatment effect on markers of inflammation (hsCRP)",{"measure":69,"timeFrame":48},"Assess the treatment effect on lipid parameters",{"measure":71,"timeFrame":48},"Assess treatment effect on waist circumference",{"measure":73,"timeFrame":48},"Assess the treatment effect on fasting plasma glucose",{"measure":75,"timeFrame":48},"Assess the treatment effect on HOMA-IR",{"measure":77,"timeFrame":48},"Assess the treatment effect on heart rate","ALL","18 Years",null,{"inclusion":82,"exclusion":83,"raw_text":84},[],[],"Inclusion Criteria:\n\n1. Signed informed consent prior to start the Screening Visit procedures.\n2. Female and male participants ≥18 years of age at time of consent\n3. BMI g ≥27.0 kg\u002Fm2 at screening.\n4. HbA1c ≥7 and ≤10% (53-86 mmol\u002Fmol) at screening.\n5. Diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening.\n6. Either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, sulfonylurea, and\u002For DPP4 inhibitor as monotherapy or combination therapy, per approved local label.\n\n   a) Note: Participants treated with sulfonylureas and\u002For DPP4 inhibitors must discontinue these at least 24 hours prior to initiation of semaglutide.\n7. Participant has had at least 1 unsuccessful attempt at weight loss by diet and exercise in the opinion of the investigator.\n8. Women of childbearing potential (WOCBP) meeting the criteria below:\n\n   i) Non-lactating and has a negative pregnancy test at screening and baseline -AND- ii) Uses an acceptable method of contraception as determined by the Investigator or Sub-Investigator for the duration of the study and 30 days following the last dose of study drug\n9. Participants must, in the opinion of the Investigator, be suitable candidates to receive semaglutide (Wegovy®) as indicated according to the product label.\n\nExclusion Criteria:\n\n1. Participant has had gastric bypass or other bariatric surgery or endoscopic procedure or any metabolic procedures (e.g. duodenal resurfacing, intragastric balloon, etc.) except for the following:\n\n   1. Liposuction and\u002For abdominoplasty that was performed \\> 1 year before screening\n   2. Laparoscopic gastric band that was removed \\> 1 year before screening\n   3. Intragastric balloon that was removed \\> 1 year before screening\n   4. Duodenal-jejunal bypass sleeve that was removed \\> 1 year before screening.\n2. Participant has had a self-reported or medically recorded change in body weight \\> 5% within 3 months of screening OR has recorded change in body weight \\>3% between screening and randomization.\n3. Participant is currently using insulin or used insulin within 3 months before screening.\n4. Participant is currently using sulfonylureas and\u002For DPP4 inhibitors and is unable or unwilling to discontinue the use of these medications at least 24 hours prior to initiation of semaglutide.\n5. Participant has a form of diabetes other than type 2.\n\n   a. Note: Previous diagnosis of gestational diabetes is permitted so long as the participant meets all inclusion and none of the exclusion criteria.\n6. Participant is currently using or used within 3 months before screening any weight reducing medication including pramlintide, sibutramine, orlistat, zonisamide, topiramate, phentermine, naltrexone, bupropion.\n7. Participant is currently using or used within 6 months before screening any medication that contains a GLP-1R agonist component or a GIPR modulator (either by prescription or as part of a clinical study)\n8. For participants with a history of prior GLP-1R agonist use (\\> 6 months prior to screening):\n\n   1. Participant has had a previous intolerance or hypersensitivity to GLP-1 receptor agonists or any of its excipients.\n   2. Participant has previously discontinued a GLP-1 receptor agonist after continuous treatment for 6 months or longer due to not meeting personal weight loss goals.\n9. Participant is taking any medication that, may cause weight gain unless the participant has used these medications for more than 6 months at a stable dose prior to screening.\n10. Participant has hepatic liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase levels \\>2.5, or total bilirubin levels \\> 1.5 times the upper limit of normal (ULN) at screening.\n11. Participant's current alcohol intake exceeds 14 units\u002Fweek for men or 7 units\u002Fweek for women (1 unit = half pint of beer, 1 glass of wine, 1 measure of spirits).\n12. Participant has a recent history of illicit substance use (\\\u003C 3 months) or in the opinion of the Investigator suspicion of current illicit substance use.\n13. Participant has uncontrolled hypertension at screening (SBP above or equal to 160 mmHg and\u002For diastolic blood pressure above or equal to 100 mmHg).\n14. A corrected QT interval (QTc) of \\> 450 msec in males or \\> 470 msec in females at screening, or history of long QT syndrome.\n15. Concurrent participation in another interventional study (e.g., of a drug, over the counter product, device) or within ≤90 days or 5 half-lives prior to Screening.\n16. Participant is unable to understand and communicate with the investigators; or to understand the protocol requirements, instructions, study-related restrictions, nature, scope, and possible consequences of the clinical study; or is unlikely to comply with the study requirements (e.g., uncooperative attitude and improbability of completing the clinical study).\n17. Participant is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the study, or employee of the sponsor, site, or Contract Research Organization (CRO).\n18. Participant whose obesity can be traced to a medical cause, suggestive of genetic or syndromic obesity of an endocrinologic disorder (e.g., hypothyroidism, Cushings syndrome, Prader-Willi syndrome).\n19. Participant has a history of an active or untreated malignancy or in remission from a clinically significant malignancy for less than 5 years, except for basal cell carcinoma.\n20. Participant has a glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2.\n21. Participant has a history of major psychiatric disorders within 5 years or lifetime history of suicide attempt.\n22. Participant has any suicidal ideation of type 4 or 5 on the C-SSRS at screening.\n23. Participant with a personal or family history of medullary thyroid carcinoma or with multiple endocrine neoplasia (MEN) syndrome type 2.\n24. Participant with a previous history of chronic pancreatitis, or acute pancreatitis within 6 months prior to screening.\n25. In the opinion of the Investigator, any disorder, condition, inability or unwillingness not covered by the exclusion criteria that may interfere with study procedures, assessments or participant's safety.",[86,87],"ADULT","OLDER_ADULT",[89,107,122,137,151,166,180,194],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":104},"CenExel Phoenix","Chandler","Arizona","85224","United States",[96,101],{"name":97,"role":98,"phone":99,"email":100},"Lee Ann Stapleton Recruitment Specialist","CONTACT","602-732-6262","l.stapleton@cenexel.com",{"name":102,"role":103},"Henry Youga, MD","PRINCIPAL_INVESTIGATOR",{"lat":105,"lon":106},33.30616,-111.84125,{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":94,"contacts":112,"geoPoint":119},"CenExel Anaheim","Anaheim","California","92801",[113,117],{"name":114,"role":98,"phone":115,"email":116},"Silvia Monico Recruitment Manager","714-774-7777","s.monico@cenexel.com",{"name":118,"role":103},"Amina Haggag, MD, FAAFP, CDCES, CPI",{"lat":120,"lon":121},33.83529,-117.9145,{"facility":123,"status":8,"city":124,"state":125,"zip":126,"country":94,"contacts":127,"geoPoint":134},"CenExel Hollywood","Hollywood","Florida","33024",[128,132],{"name":129,"role":98,"phone":130,"email":131},"May Fernandez Director of Clinical Operations","954-990-7649","m.fernandez@cenexel.com",{"name":133,"role":103},"Craig Shapiro, DO, FAOCO",{"lat":135,"lon":136},26.0112,-80.14949,{"facility":138,"status":8,"city":139,"state":125,"zip":140,"country":94,"contacts":141,"geoPoint":148},"CenExel Tampa","Tampa","33613",[142,146],{"name":143,"role":98,"phone":144,"email":145},"Beth DeLuca Director of Recruitment","813-264-2155","e.deluca@cenexel.com",{"name":147,"role":103},"Deborah White, MD",{"lat":149,"lon":150},27.94752,-82.45843,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":94,"contacts":156,"geoPoint":163},"CenExel Atlanta","Atlanta","Georgia","30331",[157,161],{"name":158,"role":98,"phone":159,"email":160},"Amber Tannahill Recruitment Manager","404-881-5800","a.tannahill@cenexel.com",{"name":162,"role":103},"Elisa Barron, MD",{"lat":164,"lon":165},33.749,-84.38798,{"facility":167,"status":8,"city":168,"state":154,"zip":169,"country":94,"contacts":170,"geoPoint":177},"CenExel Decatur","Decatur","30030",[171,175],{"name":172,"role":98,"phone":173,"email":174},"Michael Mahaffey Recruitment Specialist","404-537-1281","m.mahaffey@cenexel.com",{"name":176,"role":103},"Kimball Johnson, MD",{"lat":178,"lon":179},33.77483,-84.29631,{"facility":181,"status":8,"city":182,"state":154,"zip":183,"country":94,"contacts":184,"geoPoint":191},"CenExel Savannah","Savannah","31405",[185,189],{"name":186,"role":98,"phone":187,"email":188},"Michelle Lagares Recruitment Specialist","912-744-0800","m.lagares@cenexel.com",{"name":190,"role":103},"Marilyn Lavalle, MD",{"lat":192,"lon":193},32.08354,-81.09983,{"facility":195,"status":8,"city":196,"state":197,"zip":198,"country":94,"contacts":199,"geoPoint":206},"CenExel SLC","Salt Lake City","Utah","84107",[200,204],{"name":201,"role":98,"phone":202,"email":203},"Jenny Hunt Recruitment Manager","801-261-2000","j.hunt@cenexel.com",{"name":205,"role":103},"Ryan Black, DO",{"lat":207,"lon":208},40.76078,-111.89105,[],[],[],[],{"nct_id":4,"conditions":214,"biomarkers":218},[215,216,217],"Obesity","Overweight","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":220,"summary":221,"prompt_version":231},true,{"design":222,"status":223,"heading":224,"summary":225,"follow_up":226,"word_count":227,"commitments":228,"compensation":229,"drugs_mentioned":230},"This is a phase 2, double-blind, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving AT673 or a placebo. About 150 participants will be randomly assigned to one of three groups.","completed","Study of AT673 with Semaglutide for Type 2 Diabetes and Overweight\u002FObesity","This study is looking for adults aged 18 and older who have type 2 diabetes and are overweight or obese (BMI of 27.0 kg\u002Fm2 or higher). You also need to have a specific blood sugar level (HbA1c between 7% and 10%). The goal is to see if adding AT673 to semaglutide helps with weight loss and blood sugar control more than semaglutide alone. Researchers will compare two different doses of AT673 against a placebo (an inactive substance) when given with semaglutide. The main thing they will measure is body weight after 13 weeks. The study also looks at how AT673 affects your blood sugar (HbA1c) and how safe it is. The current status of this study is unclear, and it plans to enroll about 150 participants.","After your 13 weeks of treatment, there will be a 4-week safety follow-up period.",126,"You will start semaglutide and gradually increase the dose. At the same time, you will receive weekly injections of AT673 or a placebo for 13 weeks, followed by a 4-week safety check. Your total participation will be about 17 weeks.","Not stated in the trial record.",[41],"v2"]