[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glp---1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glp---1":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,74,100,131,168,194,220],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100629948","lifestyle-change-implementation-research-network-at-prc-at-umass-chan-100629948",false,"NCT07481305","Lifestyle Change Implementation Research Network at PRC at UMass Chan","LCIRN","Inclusion Criteria:\n\n1. Began using a GLP-1 within the past 6 months\n2. Currently using GLP-1\n3. Plans to continue GLP-1 use\n4. GLP-1 prescribed by their physician (e.g., not online or 3rd party vendor)\n5. BMI ≥27 kg\u002Fm2\n6. Age 18 years of age and older\n7. Speaks and reads English or Spanish\n8. Willing to enroll in a digital lifestyle intervention for 4-months\n9. Willing to wear a Fitbit for 8 months\n\nExclusion Criteria:\n\n1. Was taking a GLP-1 within the 2 months prior to the current GLP-1 start date\n2. Currently participating in a structured lifestyle change program (receiving structured guidance and counseling on physical activity, diet or weight loss)\n3. Currently pregnant","ALL","18 Years",{"count":19,"type":20},220,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this project is to study how well the Noom digital lifestyle program works for adults who are taking Glucagon-Like Peptide-1 receptor agonist (GLP-1) medications. The study team will assess how the program affects people's behaviors and health outcomes. The team will also look at how digital lifestyle change interventions can be implemented in real-world settings, including how many people it reaches, how well it is put into practice, whether people stick with it over time, and whether it works well for different groups of people.",[26],"GLP - 1",[28,29,30,31,32,33,34],"GLP-1","Physical Activity","Nutrition","Lifestyle Behaviors","Weight","Diabetes","CVD","NOT_YET_RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":20},"2026-07-13",{"date":43,"type":20},"2029-09-29",{"name":45,"class":46},"University of Massachusetts, Worcester","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100634146","scalable-behavioral-program-for-weight-loss-maintenance-after-glp-1-and-anti-obesity-medication-discontinuation-100634146","NCT07535892","Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation","Pilot Trial of a Scalable Behavioral Program for Weight Loss Maintenance After GLP-1 and Anti-Obesity Medication Discontinuation","Inclusion Criteria:\n\n* Age 18 years or older\n* Loss of ≥15% of initial body weight using anti-obesity medication\n* Discontinued anti-obesity medication within the past 4 weeks or planning to discontinue prior to randomization\n* ≤3 kg weight regain within the past 3 months\n* Willing and able to participate in a 6-month behavioral intervention, including a 10-week foundational program\n* Willing to complete study assessments at baseline, 3 months, and 6 months, including required in-person visits\n* Medical clearance for participation in moderate physical activity, dietary modification, and mind-based practices\n* Access to reliable internet for participation in virtual sessions and remote data collection\n* English fluency sufficient to complete study procedures\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Medical conditions that would preclude safe participation in physical activity, dietary changes, or mind-based practices (e.g., unstable cardiovascular disease, uncontrolled hypertension, severe orthopedic limitations, or seizure disorders not medically managed)\n* Active psychiatric conditions that would interfere with participation or safety (e.g., untreated major depression, active substance use disorder, or psychosis)\n* Pregnancy, breastfeeding, or plans to become pregnant during the study period\n* Current participation in another structured weight loss or weight maintenance program\n* Continued use of anti-obesity medication after randomization\n* Plans to initiate medications or treatments that may significantly affect body weight during the study period\n* Inability to attend required study visits or participate in virtual sessions and remote data collection\n* Any condition that, in the opinion of the investigators, would compromise participant safety or study integrity",{"count":56,"type":20},64,[23],"This study is a single-site, pilot randomized factorial trial designed to evaluate the feasibility, acceptability, participant perceptions and preliminary effects of a multi-component behavioral intervention to support weight loss maintenance following discontinuation of GLP-1 and other anti-obesity medications. The intervention includes a standardized 10-week foundational weight loss maintenance program combined with candidate support components, including medically tailored meals, YMCA membership, and a structured mind-based program. Participants will be randomized using a 2 × 2 × 2 factorial design and followed for six months. Findings from this pilot study will inform optimization of a scalable intervention for future clinical trials.",[60,26,61,62],"Weight Loss","Weight Loss Maintenance","Obesity & Overweight",[60,28,64,65],"Anti-Obesity Medication","weight loss maintenance","2026-06-23",{"date":38,"type":39},{"date":69,"type":20},"2026-11-01",{"date":71,"type":20},"2029-07-31",{"name":73,"class":46},"University of Alabama at Birmingham",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100631780","exploring-the-influence-of-glucagon-like-peptide--1-glp-1-medications-on-food-cravings-food-selection-and-food-intake-following-exposure-to-food-advertisements-100631780","NCT07505134","Exploring the Influence of Glucagon-like Peptide -1 (GLP-1) Medications on Food Cravings, Food Selection, and Food Intake Following Exposure to Food Advertisements","Exploring the Influence of GLP-1 Medications on External Food Cue Reactivity and Resultant Food Choice and Intake","Inclusion Criteria:\n\n* Adults (18+) with overweight or obesity (BMI \\>25 kg\u002Fm2)\n* On an injectable form of tirzepatide GLP-1 medication at a minimum dose of 7.5 mg, taking it as prescribed by their doctor\n* Not currently taking an incretin-based medication at baseline other than the GLP-1 medication\n* Fluent in English\n\nExclusion Criteria:\n\n* Do not have consistent access to a smart phone that can access the study software\n* Diagnosed with cognitive or physical disability or epilepsy\n* Adults taking a compound GLP-1","85 Years",{"count":83,"type":20},50,[23],"The purpose of this randomized control trial is to compare how food cravings, food selection, and food consumption change in response to frequent food advertisements compared to non-food advertisements in adults taking GLP-1 (weight loss) medications. The primary question we aim to answer is: do GLP-1 medications reduce an individual's vulnerability to external triggers that drive food cravings and consumption?\n\nParticipants will:\n\n* report daily food consumption for a total of 10 days,\n* receive eight daily prompts to view food or non-food related advertisements, and respond to a short 9-question survey for 7 days,\n* answer several questionnaires,\n* and complete two in-person visits to complete a virtual reality food selection task.",[26],[28,88,89,90],"Food choice","Cravings","Food cue reactivity","2026-04-27",{"date":93,"type":39},"2026-05-01",{"date":95,"type":20},"2026-05",{"date":97,"type":20},"2026-09",{"name":99,"class":46},"Penn State University",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":47},"100635571","phase-4-combatting-muscle-loss-in-obese-adult-patients-on-glp-1-medications-through-dietary-counseling-and-exercise-during-treatment-evaluates-whether-a-12-week-exercise-and-individualized-nutrition-program-can-reduce-muscle-and-bone-loss-and-improve-strength-fitness-and-function-in-obese-adults-on-glp-1-100635571","NCT07554417","Combatting Muscle Loss in Obese Adult Patients on GLP-1 Medications Through Dietary Counseling and Exercise During Treatment Evaluates Whether a 12-week Exercise and Individualized Nutrition Program Can Reduce Muscle and Bone Loss and Improve Strength, Fitness, and Function in Obese Adults on GLP-1","Combatting Muscle Loss in Obese Adult Patients on GLP-1 Medications Through Dietary Counseling and Exercise During Treatment","Inclusion Criteria:\n\n* Age between 40 and 55 years\n* Body Mass Index (BMI) greater than 30\n* Body fat percentage greater than 30% for males and 40% for females\n* Android to gynoid fat ratio greater than 1.0\n* Currently eligible for GLP-1 therapy\n* No diagnosis of Type II diabetes\n\nExclusion Criteria:\n\n* Presence of abnormal ECG findings, including arrhythmias or ischemic changes\n* Hypertensive response to exercise, defined as systolic blood pressure exceeding 250 mmHg or diastolic pressure exceeding 115 mmHg\n* Hypotensive response to exercise, defined as a drop in systolic pressure greater than 10 mmHg with increasing workload\n* VO₂ max below 15 ml\u002Fkg\u002Fmin\n* Borg Rating of Perceived Exertion (RPE) greater than 19 during submaximal workloads\n* Any contraindications to exercise as defined by ACSM guidelines\n* Musculoskeletal limitations that prevent safe participation in exercise","40 Years","55 Years",{"count":110,"type":20},20,[112],"PHASE4","Obesity remains a critical public health challenge and is associated with increased rates of morbidity, mortality, and chronic disease worldwide. In recent years, glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, have emerged as highly effective pharmacological treatments for obesity, producing substantial weight loss and favorable metabolic improvements. These medications are now widely prescribed, with estimates suggesting that nearly 12% of Americans are currently using or have previously used GLP-1 therapies. Despite their demonstrated benefits, growing evidence indicates that GLP-1-associated weight loss may be accompanied by unintended reductions in skeletal muscle and bone mass. This potential side effect is of increasing concern, as muscle and bone are essential for metabolic health, physical function, injury prevention, and recovery from illness or surgical intervention.\n\nLoss of skeletal muscle during weight reduction may negatively impact strength, mobility, insulin sensitivity, and long-term health outcomes. These risks may be further compounded in individuals experiencing reduced physical activity, mechanical unloading, or prolonged caloric deficits. In clinical and surgical populations, such as individuals undergoing orthopedic procedures, mechanical unloading and disuse already predispose patients to muscle and bone atrophy. When combined with pharmacologically induced weight loss, these factors may further hinder recovery, impair functional capacity, and compromise musculoskeletal integrity. As GLP-1 therapies are increasingly adopted across diverse populations, understanding how to preserve lean mass and bone health during treatment has become an important clinical and public health priority.\n\nExercise training, particularly resistance training, combined with appropriate nutritional support, has consistently been shown to preserve and enhance skeletal muscle and bone mass during weight loss. Structured exercise interventions can mitigate sarcopenia and osteopenia while improving muscular strength, cardiorespiratory fitness, metabolic health, and overall physical function. Similarly, individualized dietary counseling, particularly when focused on adequate protein intake and nutrient timing, plays a critical role in supporting muscle protein synthesis and skeletal health during caloric restriction. Together, these lifestyle strategies may not only counteract the potential adverse musculoskeletal effects associated with GLP-1 therapy but also enhance treatment efficacy by improving cardiovascular risk profiles, insulin sensitivity, systemic inflammation, and physical resilience.\n\nDespite the growing use of GLP-1 medications, there remains a limited body of prospective research examining structured lifestyle interventions specifically designed to preserve muscle and bone mass during GLP-1-induced weight loss. Addressing this gap is essential to ensure that pharmacological obesity treatments support long-term health, functional independence, and quality of life. Integrating exercise and nutrition interventions into GLP-1 treatment protocols may represent a scalable and clinically meaningful strategy to optimize outcomes and reduce unintended consequences of rapid weight loss.\n\nThe purpose of this study is to evaluate whether a structured lifestyle intervention combining exercise and individualized nutritional counseling can mitigate skeletal muscle mass loss in obese adults undergoing treatment with GLP-1 receptor agonists. The primary objective of this study is to determine whether participation in a structured 12-week exercise program, in conjunction with individualized dietary counseling, preserves skeletal muscle mass and bone mineral density during GLP-1 therapy. Secondary objectives include assessing changes in muscular strength, cardiorespiratory fitness, and overall functional capacity. Findings from this study aim to inform best practices for integrating lifestyle interventions with pharmacological obesity treatments and to support safer, more effective, and functionally protective approaches to weight management in adults receiving GLP-1 therapy.",[26,62,115,116,117],"Muscle Loss","Exercise Intervention","Dietary Assessment",[28,119,120,121],"Semaglutide","obesity","exercise intervention","2026-04-21",{"date":124,"type":39},"2026-04-28",{"date":126,"type":20},"2026-04-06",{"date":128,"type":20},"2026-08-06",{"name":130,"class":46},"William Marsh Rice University",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":144,"conditions":145,"keywords":151,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":47},"100585558","phase-2-bone-metabolism-in-12-21-year-olds-undergoing-glucagon-like-peptide-glp-1-receptor-agonist-therapy-100585558","NCT06903923","Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy","Bone Metabolism in Adolescents Undergoing GLP-1 Receptor Agonist Therapy","Inclusion Criteria:\n\n* • Adolescents and young adults with obesity 12-21 years old starting GLP-1 RA therapy (except for dulaglutide or exenatide) or followed with 'usual' care.\n* Diagnosis of obesity (BMI ≥ 95th percentile for age and sex). The FDA has approved the use of GLP-1 RAs (liraglutide and semaglutide) for adolescents ≥ 12 years old with BMI ≥ 95th percentile for age and sex, and tirzepatide for adults with obesity. Those in the GLP-1 RA arm must have demonstrated efforts at weight loss with 'usual' care, and consistent compliance with appointments and recommendations.\n* Participants must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of being on medical therapy and implement required behavioral changes\n* Patients taking orlistat as a precursor to GLP-1 RA therapy due to insurance requirements may be included given minimal effects on weight.\n* Use of the following contraceptive methods is permitted: Combine oral contraceptives (COCs); continuous oral progestin; Progestin-releasing intrauterine device (IUD); Progestin implant; transdermal patch.\n* Patients with celiac disease will be included if the condition is well controlled and they are on a gluten free diet with normal 25(OH)D levels confirmed by clinical labs within 3 months of enrollment in the study. If a patient does not have recent 25(OH)D results, we will add this to the screening labs.\n\nExclusion Criteria:\n\n* • Current or previous history of pregnancy and breast feeding.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 if in the GLP-1 RA group.\n* \\> 5 kg weight loss over 3 months given the known impact of significant weight loss on bone density.\n* Use of dulaglutide and exenatide (of the GLP-1 RAs) given minimal weight loss with these drugs.\n* Use of medications such as metformin, phentermine, or topiramate that may cause weight loss, or obesogenic antipsychotic medications if treated for \\\u003C3 months, or if dosage is not stable for \\>2 months.\n* Medications other than calcium or vitamin D that affect bone, such as systemic glucocorticoids, phenytoin, phenobarbitone (unless there is a washout period of 3 months prior to enrollment if discontinuation is medically permissible)\n* Female participants on hormonal contraception will be excluded if this involves use of depot medroxyprogesterone acetate (DMPA). DMPA has profound deleterious effect on bone density, which could confound study outcomes related to bone health. Rationale: DMPA has a well-documented deleterious effect on bone density, which could confound study outcomes related to bone health or metabolic parameters.\n* Untreated thyroid dysfunction or on stable dose for \\\u003C3 months. Primary thyroid dysfunction will be defined as: a TSH ≥ 10 IU\u002FL or low per given reference range with unknown thyroid antibody status, or an abnormal TSH if known positive antibodies. Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a normal TSH. For patients with secondary hypothyroidism (deficient production of TSH from the pituitary gland causing hypothyroidism), normal free T4 concentrations (and not TSH alterations) will be used for study inclusion, and recent adjustments in the levothyroxine dose will be permissible as long as free T4 concentrations are in the normal range at dose adjustment (as dose adjustments are often made to get free T4 concentrations in the upper half of the normal range when assessed levels are in the lower half of the normal range). Patients with hyperthyroidism will be excluded given known deleterious effects on both weight and bone metabolism.\n* Medical conditions known to impact weight or bone density, such as chronic gastrointestinal disorders (including inflammatory bowel disease), other inflammatory conditions, such as rheumatoid arthritis or ankylosing spondylitis, untreated thyroid disease, and hypercortisolemia.\n* HbA1C \\>8% (to avoid deleterious effects on bone from uncontrolled T2DM).\n* Smoking \\>10 cigarettes\u002Fday given deleterious effects on bone; substance abuse per DSM-5.\n* Weight \\>450 lbs due to limits for DXA scanners.\n* History of metabolic and bariatric surgery.\n* Judged by the investigators to be inappropriate for the study for other reasons not detailed above.","12 Years","21 Years",{"count":141,"type":20},120,[143],"PHASE2","The goal of this clinical trial is to compare bone health markers over 24 months in participants 12 - 21 years of age with obesity who are starting the glucagon-like peptide-1 receptor agonists (GLP-1RAs) as compared to those with similar weight followed by lifestyle management.\n\nParticipants will:\n\n* Take GLP-1RA as prescribed or continue to work on lifestyle management for weight loss\n* Take provided calcium and vitamin D supplements\n* Attend 6 study visits over 24 months with two at the beginning and then every 6 months that include:\n\n  * History and Physical Exams\n  * Lab Work\n  * Imaging studies\n  * Questionnaires\n  * 24-hour dietary recalls",[146,147,26,148,149,150],"Obesity in Children","Bone Strength","Lifestyle Modification","Bone Density","Obesity",[120,152,153,28,154,155,156,157],"obesity in children","bone strength","Lifestyle modification","bone density","semaglutide","liraglutide","RECRUITING","2026-04-15",{"date":161,"type":39},"2026-04-17",{"date":163,"type":39},"2025-07-31",{"date":165,"type":20},"2030-04-30",{"name":167,"class":46},"University of Virginia",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":175,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":177,"briefSummary":178,"conditions":179,"keywords":183,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":47},"100578440","phase-2-effects-of-tirzepatide-on-muscle-and-vascular-health-in-obese-older-adults-100578440","NCT06811324","Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults","The Effects of Tirzepatide Use on Muscle and Vascular Function Among Obese Older Adults","Inclusion Criteria\n\n* Men and postmenopausal women aged 50 years or older.\n* Body Mass Index (BMI) ≥30 kg\u002Fm².\n* Untreated HbA1c \\\u003C6.5% at baseline.\n* Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.\n* Able to provide informed consent and participate in all study assessments.\n\nExclusion Criteria\n\n* Active diagnosis of type 2 diabetes mellitus (T2DM), defined by active use of glucose-lowering medications or hemoglobin A1c ≥ 6.5%.\n* Body Mass Index (BMI) ≥ 40 kg\u002Fm².\n* Moderate to severe gastroesophageal reflux disease based on patient history.\n* Inability to comply with the treatment protocol or to understand the consent form.\n* Chronic Kidney Disease (CKD) Stage 4.\n* Aspartate aminotransferase (AST) \\> 33 U\u002FL or alanine aminotransferase (ALT) \\> 36 U\u002FL.\n* Active pregnancy.\n* Personal or family history of medullary thyroid carcinoma.\n* Personal or family history of multiple endocrine neoplasia type 2 syndrome.\n* Personal history of gastroparesis.\n* Personal history of diabetic retinopathy.\n* Known serious hypersensitivity, including anaphylaxis and angioedema, to Tirzepatide or any of its excipients.\n* Known serious hypersensitivity, including anaphylaxis and angioedema, to any GLP-1 receptor agonist class of therapies.\n* Concomitant treatment with GLP-1 receptor agonist therapy","50 Years",{"count":110,"type":20},[143],"Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health. Utilization of tirzepatide among older adults has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older adults with obesity are not well established. Recent studies show that weight loss caused by tirzepatide may be driven by substantial loss of lean muscle mass, which may contribute to weakness and frailty, particularly among older adults. The proposed pilot study aims to evaluate how treatment with tirzepatide for 6 months affects muscle mass and function among older adults, and if changes in muscle mass are linked to changes in functional status over the same time period.",[180,181,182,26,60],"Obesity Prevention","Sarcopenia in Elderly","Cardiovascular Function",[184,28,150,185,182],"Tirzepatide","Sarcopenia","2026-04-10",{"date":159,"type":39},{"date":189,"type":39},"2026-04-01",{"date":191,"type":20},"2027-06-01",{"name":193,"class":46},"The University of Texas Health Science Center at San Antonio",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":47},"100609352","phase-4-individualized-pharmacological-approach-to-obesity-in-patients-with-bipolar-disorder-100609352","NCT07213466","Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder","Individualized Pharmacological Approach to Obesity in Patients With Bipolar Disorder - OBOE-Mayo","OBOE-Mayo","Inclusion Criteria:\n\n* Men or women between 18 to 65 years old.\n* Patients with a SCID IV confirmed diagnosis of bipolar disorder (BDI or BDII) or schizoaffective bipolar type (SZA-BD).\n* Women with a negative pregnancy test 48 hours before study entry (obesity phenotyping visit).\n* Patients with a negative urine drug screen except for allowable drugs.\n* Patients with a BMI ≥ 30 kg\u002Fm2 or a BMI ≥ 27 kg\u002Fm2 plus one medical comorbidity (e.g., type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea)\n* Patients must be undergoing mood stabilizer treatment but may also receive concurrent antidepressant or anxiolytic therapy.\n* Patients must be on a stable regimen of a mood stabilizer, with no changes to the medication, for at least one month prior to study enrollment.\n* Continuation of mood-stabilizing treatment is preferred but not required; the decision should be made in collaboration with the participant's primary mental health provider.\n\nExclusion Criteria:\n\n* Abdominal bariatric surgery: Gastric bypass surgery (Roux-en-Y), Adjustable gastric band (Lap band), and Gastric sleeve surgery (Sleeve gastrectomy).\n* Positive history of chronic gastrointestinal diseases, or systemic disease that could affect gastrointestinal motility, such as diabetic gastroparesis; or use of medications that may alter gastrointestinal motility and appetite.\n* Positive history of chronic gastrointestinal diseases that could affect gastrointestinal absorption such as inflammatory bowel disease (IBD), celiac disease, small intestinal bacterial overgrowth (SIBO), etc; or use of medications that may alter gastrointestinal absorption.\n* Significant untreated psychiatric dysfunction.\n* Hypersensitivity to any of the study medications.\n* Contraindications to the FDA-approved medications: Phentermine-Topiramate Extended Release; Oral naltrexone extended-release\u002Fbupropion extended-release (NBSR; Contrave®, Mysimba™); and Semaglutide (Weygovy™).\n* Inability to provide informed consent: participants who are on involuntary commitment, conservatorship or under a legal guardian.\n* Patients with active hypomania or mania (YMRS ≥ 20 points)\n* Patients with active psychosis (YMRS item 8 ≥ 6 points)\n* Patients with active suicide ideation (MADRS item 10 ≥ 4 points)\n* Patients with any medication changes (mood stabilizers) without advisement of study clinicians or clinical provider.\n* Patients with active bulimia (purging) or anorexia (severe restriction)\n* Patients with a history of bulimia (purging behaviors) or anorexia (severe dietary restriction) within the 12 months preceding study enrollment will be excluded\n* Current drug and\u002For alcohol use disorders (except nicotine)\n* Patients with a positive toxicology screening (except cannabis)\n* Positive toxicology screen for cannabis and a cannabis use disorder by CUDIT-R.\n* Participants who use cannabis for recreational or medicinal purposes and fail the toxicology screen can potentially be included in the study only if they take the CUDIT-R and score a 12 or less.\n* Patients unwilling to complete the full phenotyping day on its current form (i.e. patients avoiding gluten meal or adhering to a vegan diet).","65 Years",{"count":204,"type":20},100,[112],"The goal of this clinical trial is to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss, and to study the effect of individualized guided medication in patients with bipolar disorder ages 18-65. The main questions it aims to answer are:\n\n* Can the investigators compare the distribution of obesity characteristics (hungry brain, hungry gut, emotional hunger) between bipolar patients and non-bipolar participants (comparing from IRB #24-002375)?\n* Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder?\n\nParticipation will last for about 20 weeks and includes 8 in-person study visits, up to 11 phone call visits, and 13 virtual group therapy sessions. The first visit lasts about 2 hours and includes going over the informed consent form, a diagnostic interview to confirm diagnosis, gathering vital signs, mood questionnaires, an ECG, a blood draw, and urine drug and pregnancy tests (if applicable). The second visit lasts about 6-7 hours and involves multiple procedures and completing questionnaires to determine which study drug would allow participants to lose weight most effectively. At the third visit, participants will be assigned to take one of three FDA approved medications for weight loss: Semaglutide (Wegovy®), Naltrexone\u002FBupropion (Contrave®), or Phentermine\u002FTopiramate (Qsymia®). It is possible that participants could be assigned to a group that receives no study medication. All participants will be enrolled in a 12-week virtual group therapy program targeted for weight loss. On this third visit the investigators will also gather vital signs, and participants will give a sample of blood. After the third visit, participants will come in for study visits every 4 weeks for 20 weeks (5 visits) to assess medication adherence, vitals, and answer questions about mood and eating (participants will also give a sample of blood at the 8-week and 20-week visits). For participants assigned to a study medication, the study team will call every week for the first 2 months (excluding in-person visit weeks) to assess mood and safety. After the first 2 months, the study team will call the participant every two weeks in between in-person visits. Participants will be compensated for time spent in this study. Participants assigned to a study medication will also be given the option to participate in the open-label phase of the study, which involves 3 follow-up visits (weeks 24, 36, and 48) over 7 months after the 20-week trial. During this phase, participants can continue to take the medication through their clinical care provider.",[208,209,210,150,60,26],"Bipolar I Disorder","Bipolar II Disorder","Schizo Affective Disorder","2026-03-06",{"date":213,"type":39},"2026-03-11",{"date":215,"type":39},"2026-01-19",{"date":217,"type":20},"2029-02-01",{"name":219,"class":46},"Mayo Clinic",{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":227,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":21,"phases":230,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100602733","phase-4-the-impact-of-glp-medication-on-colonoscopy-bowel-preparation-quality-100602733","NCT07127354","The Impact of GLP Medication on Colonoscopy Bowel Preparation Quality","The Impact of GLP-1 Agonist and GIP Agonist on Bowel Preparation Quality: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patient (Age 18 years or older)\n* Patient scheduled for outpatient screening, surveillance, or diagnostic colonoscopy\n* Using a GLP-1 or GIP agonist at a stable dose for at least one month\n\nExclusion Criteria:\n\n* Unable to provide informed consent, e.g., dementia\n* Patient refuses the USMSTF recommended bowel cleansing regimen for patients with diabetes or obesity (split-dose 4 liters polyethylene glycol + 15 mg bisacodyl the afternoon before; low residue diet 3 days before colonoscopy; clear liquid diet the day before colonoscopy)\n* Risk factors for inadequate bowel preparation besides diabetes and obesity with a likelihood ratio of 1.6 or greater:\n\n  1. Cirrhosis\n  2. Parkinson's disease\n  3. Dementia\n  4. Tricyclic antidepressant use\n  5. Opioid use\n  6. Gastroparesis\\* or suspected gastric outlet obstruction on pre-procedure imaging (\\*defined based on a documented 4-hour solid phase gastric emptying study or prior history of retained gastric contents during upper endoscopy)\n  7. Previous colorectal surgery\n  8. Prior history of inadequate bowel preparation",true,{"count":229,"type":20},132,[112],"The goal of this clinical trial is to learn how GLP-1 and GIP agonists effect bowel preparation in patients scheduled for colonoscopies. The main questions it aims to answer are:\n\n* Does GLP-1 and GIP agonist increase the rate of inadequate bowel preparation?\n* Does the quality of bowel preparation differ in patients who hold vs. those who continue a single dose of their GLP-1 or GIP agonist medication?\n* Are there any differences in the rates of complications gastric aspiration in patients who hold vs. continue a single dose of their GLP-1 or GIP agonist medication?",[26,233],"Bowel Preparation for Colonoscopy",[28,235],"Bowel preparation for colonoscopy","2025-12-02",{"date":238,"type":39},"2025-12-04",{"date":240,"type":39},"2025-08-01",{"date":242,"type":20},"2026-08",{"name":244,"class":46},"The Cleveland Clinic",3]