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Showing 1-20 of 3,605 trials
NCT07213466
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: * 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)? * Can the investigators evaluate the feasibility of anti-obesity medication (AOM) in patients with bipolar disorder? Participation 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/Bupropion (Contrave®), or Phentermine/Topiramate (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.
NCT04513587
The aim of this study is find out how CBT-based weight loss program affects on eating behavior, weight loss, mood symptoms and risk for coronary heart diseases and type 2 diabetes and applicability of the program to obesity treatment among patients with comorbid depression. Our hypothesis is that the CBT-based intervention improves long-term weight management results and supports positively the change in eating behavior and the risk for CHD on type 2 DM. The study is randomized controlled one-year intervention study with 1 year follow-up. Study subjects are adult obese (BMI\>35) subjects with comorbid depression. Number of randomized study subjects will be 80, 40 in intervention group, 40 in control group. Intervention group will proceed through a 52-week CBT-based weight loss group intervention. The aim of the intervention is to modify eating behavior and lifestyle factors affecting weight and weight maintenance. There will be 22 group counselling of 90 minutes divided in five modules and also three individual person-centered counselling visit, during which participants had an opportunity to discuss their personal concerns about diet and weight loss plan. Control group will receive the usual care of obesity in Kuopio University hospital. (4-8 individual 45-minute visit conducted by dieticians) Study visits are at baseline and one and 2 years after baseline. For example eating behavior, health behavior, motivation and depression are studied with questionnaires. Weight, waist circumference, height and blood pressure are measured. Laboratory tests (lipid, glucose etc) are taken.
NCT06564753
This is a Phase 2 randomized, double-blind, placebo-controlled, parallel arm study of NA-931 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.
NCT06137365
The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.
NCT05799846
The goal of this clinical trial is to compare weight change and other related outcomes associated with three different behavioral weight loss interventions (STANDARD Behavioral, PREVENT, and PROMOTE) in adults with obesity. The main questions it aims to answer are: * Which of the three Internet-delivered weight loss programs results in the greatest weight loss? * How do key weight-related behaviors (e.g., adherence, diet, physical activity) differ across the arms? * What individual characteristics predict success in each arm? * What are the underlying mechanisms of each approach? * Are there any potential adverse outcomes associated with any of the conditions (e.g., depression, weight stigmatization, increased body image concerns). Participants will: * signed informed consent * complete a baseline assessment * be randomized to 12 months of either Standard iBWL, PREVENT or PROMOTE * complete a training workshop to learn arm-specific cognitive strategies * complete a 12-month Internet-delivered weight loss program, requiring self-monitoring of intake and exercise and viewing of 12 weekly lessons followed by 9 monthly lessons * complete an assessment at 3 months (during treatment) * complete a refresher workshop on arm-specific cognitive strategies at 3 months * complete an assessment at 6 months (during treatment), 12 months (at the conclusion of treatment), and 18 months (6 months after treatment
NCT06530017
To evaluate the effectiveness and safety of Ingested, Space Occupying hydrogel capsules for simple obesity treatment
NCT02741518
This is a randomized controlled pilot study to assess the microbiological and clinical impacts of Fecal Microbiota Transplantation (FMT) in patients with obesity. The investigators will prospectively enroll 20 adult patients who are obese (Body Mass Index of 35kg/m2 or higher) after providing written informed consent. The study participants will be randomized 1:1 to either the treatment arm or the placebo arm. The treatment arm will receive an induction FMT with capsules followed by a monthly maintenance dose of oral capsules for 12 weeks total. The placebo group will receive a placebo capsules for induction followed by monthly intake of oral placebo capsules for 12 weeks.
NCT04801641
Obesity is a serious health problem which increases the likelihood of developing other life-changing medical conditions. Despite increasing knowledge about the neural and metabolic basis of obesity, the development of effective anti-obesity treatment strategies has been a challenge. Evidence shows an association between cannabis consumption and body weight. However, to date, no human trials have assessed the potential of cannabis-like compounds to reduce body weight in individuals who are obese. This pilot trial aims to determine the safety and feasibility of administering nabilone (a cannabinoid drug similar to the active component of cannabis) to patients who are obese. Our secondary aims are to determine if nabilone is effective in reducing weight in this population, and to probe potential mechanisms of the weight-loss-promoting effects of nabilone, such as neural reactivity to food stimuli, changes in gut bacteria, and changes in metabolic biomarkers.
NCT06704581
This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
NCT02079051
We are proposing a trial to directly compare a high intensity weight loss protocol to a moderate intensity weight loss protocol to determine which leads to greater improvements in physical function in severely obese older adults.
NCT06867718
This is a phase 2, 36-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of RGT001-075 in adults who are obese (BMI ≥30 kg/m²) or who are overweight (BMI ≥27 kg/m²) with at least one weight-related comorbidity. RGT001-075 or matching placebo will be administered once daily.
NCT06717425
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07976016) for the potential treatment of obesity. The study will compare the experiences of participants taking the study medicine (PF-07976016) to those of participants who take placebo (a lookalike substance that contains no active study medicine). The aim is to measure the body's response to the study medicine, including any changes in participants' body weight and how well they tolerate the study medicine.
NCT07192263
This Phase 3 study is designed to evaluate the efficacy and safety of IN-B00009 injection in adults with obesity or overweight without diabetes mellitus
NCT07274137
This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study to evaluate the efficacy and safety of the oral small molecule MDR-001 Tablets over 52 weeks as an adjunct to a lifestyle intervention in participants with overweight or obesity.The goal of this clinical trial is to determine whether the oral drug MDR-001 can improve weight management in adult participants with overweight or obesity.
NCT00537758
This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL) treatments for obese patients with binge eating disorder (BED). The study involves a comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part) treatment consisting of CBT followed by BWL.
NCT07455630
Obesity is a major public health problem worldwide and an established risk factor for cardiovascular disease. In individuals with obesity or overweight, systemic inflammation and endothelial dysfunction contribute to myocardial hypertrophy, ventricular remodeling, and alterations in cardiac morphology and function. Weight loss has been shown to improve metabolic and hemodynamic parameters; however, evidence regarding structural and functional cardiac reversibility remains limited. This prospective single-center cohort study aims to evaluate changes in cardiac morphology and function (assessed by cardiac magnetic resonance imaging and echocardiography), as well as changes in inflammatory and cardiac biomarkers, in patients with obesity or overweight and cardiovascular risk factors who achieve at least a 10% reduction in body weight through pharmacological or non-pharmacological interventions.
NCT04667377
This study is open to adults, aged 18 to 75 years, with overweight or obesity. People with body mass index (BMI) of 27 or higher to join the study. People who have diabetes cannot participate. The purpose of this study is to find out whether a medicine called BI 456906 helps people lose weight. Participants are put into 5 groups by chance. 4 groups get different doses of BI 456906. The fifth group gets placebo. Participants get BI 456906 or placebo as injections under the skin once a week. Placebo injections look like BI 456906 injections but do not contain any medicine. Participants are in the study for about a year. During this time, there are about 20 in-person visits to the study site. At the study site visits, doctors measure participants' body weight. Results are compared between the BI 456906 groups and the placebo group. The doctors also regularly check the general health of the participants.
NCT01970566
Obesity is a prevalent disorder and linked with inflammation, insulin resistance, dyslipidemia, obstructive sleep apnea, atherosclerosis, and associated with significant morbidity and mortality. This randomized clinical trial will compare the effectiveness of Intense Exercise/Moderate Calorie Restriction (IE-MCR), Topiramate-Phentermine (TP) and cognitive behavioral therapy (CBT) on obesity and atherosclerosis in individuals with morbidly obesity. This randomized clinical trial will compare: 1) the change in fat mass and atherosclerosis, 2) the change in psychological and quality-of-life as well as economic burden in response to IE-MCR, TP and CBT, and 3) conduct exploratory mechanistic biomolecular, genetic and therapeutic analyses to develop intervention-specific individualized intervention models to improve management of morbidly obese individuals.
NCT03374956
The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.
NCT03488212
Behavioral obesity treatment produces clinically significant weight loss; for the greatest impact, it should be made available in the primary care setting where it can reach the many patients with overweight/obesity. The investigators developed a 3-month automated online behavioral weight loss program, Rx Weight Loss (RxWL), and showed that it produces clinically significant weight losses among primary care patients. The investigators' early efforts at pragmatic implementation of RxWL have been promising, and have shed light on challenges associated with implementation, and the need to study longer-term effectiveness. The investigators will therefore conduct a pragmatic study to improve the implementation and effectiveness of this behavioral obesity intervention delivered in routine and representative healthcare settings. The investigators are partnering with the Rhode Island Primary Care Physicians Corporation (RIPCPC), a large primary care network of 58 practices with 100 physicians and 16 nurse care managers. Using the framework for Effectiveness-Implementation Hybrid Designs, the investigators will simultaneously target effectiveness and implementation to maximize the public health impact of the research. Half of the 16 nurse care managers, and the practices they serve, will be randomized to either Basic Implementation (alerts generated using the electronic medical record \[EMR\] to direct eligible patients to RxWL), or to the Enhanced Implementation (alerts, clinician skills training to motivate and support weight loss, clinician dashboard with reports on patient progress and tools to facilitate patient engagement and behavior change). The investigators will test the hypothesis that the Enhanced Implementation will increase the proportion of patients directed to, enrolling, and completing the weight loss program. Because maintenance of weight loss is a critical problem, this project will also involve randomization of 600 patients with overweight/obesity and type 2 diabetes, hypertension, and/or hypercholesterolemia to the 3 month RxWL intervention followed by one of three maintenance conditions: (a) Control- 9 monthly online education sessions; (b) Monthly Lessons and Feedback- 9 monthly online video lessons teaching self-regulation with automated feedback on the self-monitoring record; (c) Refresher Campaigns- 9 monthly on-line video sessions, teaching self-regulation and providing two 4-week courses with novel strategies and behavioral challenges to improve long-term outcomes. The investigators will test the hypothesis that 12-month weight losses are better with Refresher Campaigns than Monthly Lessons and Feedback, and both are better than Control. Secondary outcomes include changes in weight, CVD risk factors, and medication use over a full 24 months. The project is significant and innovative because: it uses an empirically validated approach to obesity treatment that is integrated into the primary care setting, leveraging existing staff and EMR capabilities; it has a dual focus on improving effectiveness and implementation; it has a pragmatic design in partnership with a large primary care network that treats a diverse patient population; and it has potential to it provides a scalable, sustainable approach that can serve as a model for broader dissemination of obesity treatment intervention.