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108 Obesity Trials near Plymouth, IN
Power is an online platform that helps thousands of Obesity patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerBerries for Inflammation
Chicago, Illinois
The primary objectives are to characterize changes in indices of systemic and gut inflammation, assess host- and microbial-derived metabolite pools, and describe and link functional metagenomics and metatranscriptomic alterations in the gut microbiome with metabolite and inflammatory outcomes after acute (24hr) and chronic (4 week) intake of anthocyanins and ellagitannins from strawberry and red raspberries compared to a control diet (negative control), FOS (positive control, non-polyphenol, carbohydrate-based fermentable fiber/pre-biotic), or combination diet (berry composite + FOS) in human participants with low-grade inflammation.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:20 - 60
Key Eligibility Criteria
Disqualifiers:Smoking, Cardiovascular Disease, Diabetes, Cancer, Others
Must Not Be Taking:Lipid-lowering, Anti-inflammatory, Probiotics, Others
105 Participants Needed
Exercise Training for Vascular Dysfunction in Obesity
Chicago, Illinois
The main objective is to examine DNA hypomethylation as an underlying mechanism for the increased production of inflammatory cytokines and the impaired vascular function in obese individuals and as a potential target for nonpharmacological preventive/therapeutic interventions such as aerobic exercise.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Cancer, Heart Disease, Kidney Disease, Others
80 Participants Needed
Behavioral Weight Loss Treatment for Obesity
Chicago, Illinois
This trial aims to understand why people with lower income have more difficulty losing weight. Participants will follow a typical weight loss program, and researchers will study how focusing on immediate needs and daily stress affect their success. The goal is to find better ways to help these individuals stick to their weight loss plans.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Non-English Speakers, Bariatric Surgery, Osteoporosis, Cognitive Impairment, Active Substance Abuse, Others
230 Participants Needed
Gastric Balloon for Obesity
Chicago, Illinois
This trial tests a stomach device and a healthy lifestyle program to help adults with obesity lose weight. The device makes people feel full sooner, and the program supports better eating and exercise habits.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:22 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
1000 Participants Needed
Mango Consumption for Obesity
Chicago, Illinois
The primary objective of this project is to provide new knowledge through a comprehensive set of analyses that investigate the complex interplay between regular mango intake, gut microbial structure/ function, mechanisms of inflammation and insulin sensitivity in over weight (OW)/obese (OB) human subjects with chronic low-grade inflammation.
Trial Details
Trial Status:Active Not Recruiting
Age:20 - 60
Key Eligibility Criteria
Disqualifiers:Not Listed
60 Participants Needed
Time Restricted Eating for Weight Management
Chicago, Illinois
A 12-month randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 6-month weight loss period; and (2) 6-month weight maintenance, will be implemented. Adults with obesity will be randomized to 1 of 3 groups: (1) 8h-TRE, ad libitum food intake from 12pm to 8 pm, fasting from 8 pm to 12 pm daily, (2) CR, 25% energy restriction every day; or 3) control, ad libitum food intake daily, eating within more than 10 hours per day.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Not Listed
90 Participants Needed
Orforglipron for Pediatric Obesity
Chicago, Illinois
The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:6 - 17
Key Eligibility Criteria
Disqualifiers:Weight Reduction Surgery, Type 1 Diabetes, Thyroid Carcinoma, Others
125 Participants Needed
RO7204239 + Tirzepatide for Obesity
Oak Lawn, Illinois
The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants will stop treatment with tirzepatide and a 24-week post-treatment follow-up (FU) period.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Diabetes, Cardiovascular, Endocrine, Others
Must Be Taking:Tirzepatide
285 Participants Needed
Petrelintide for Obesity and Type 2 Diabetes
Chicago, Illinois
The main purpose of this study is to investigate efficacy and safety of three doses of petrelintide versus placebo in participants with overweight or obesity and type 2 diabetes.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Severe Hypoglycemia, Obesity Surgery, Others
Must Be Taking:Metformin, SGLT2 Inhibitors
216 Participants Needed
CO2 Treatment for Obesity
Chicago, Illinois
The primary objective of this study is to demonstrate the efficacy and safety of the carbon dioxide for subcutaneous fat reduction.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Pregnancy, Asthma, COPD, Skin Infection, Others
Must Not Be Taking:Diet Pills
25 Participants Needed
Meal Replacement and Lifestyle Modification for Obesity
Chicago, Illinois
In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables.
Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 15
Key Eligibility Criteria
Disqualifiers:Bariatric Surgery, Diabetes, Cancer, Others
Must Not Be Taking:Anti-obesity, Supplemental Hormones
260 Participants Needed
Mirikizumab + Tirzepatide for Ulcerative Colitis
Chicago, Illinois
The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight.
Participation in this study will last up to 61 weeks, including 52 weeks of treatment.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Crohn's Disease, Type 1 Diabetes, Others
350 Participants Needed
Ixekizumab + Tirzepatide for Psoriasis
Chicago, Illinois
The main purpose of this study is to demonstrate that when participants with moderate to severe plaque psoriasis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriasis and achieve weight reduction compared to when receiving ixekizumab.
Participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:T1DM, Obesity Surgery, Cancer, Others
Must Not Be Taking:Insulin, IL-17 Inhibitors
250 Participants Needed
Semaglutide for Atrial Fibrillation
Chicago, Illinois
The goal of the study is to learn how a weight loss medication called semaglutide, which is used to treat obesity, in addition to standard AF treatment might affect AF, atrial fibrillation severity, and whether it changes the risk of atrial fibrillation recurring after standard AF treatments.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type I Diabetes, Active Malignancy, Others
Must Not Be Taking:GLP-1 RA, DPP4-inhibitors
200 Participants Needed
Retatrutide for Obesity
Chicago, Illinois
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Diabetes, Thyroid Carcinoma, Pancreatitis, Others
Must Not Be Taking:Weight Loss Drugs, Stimulants, Hypnotics, Others
2300 Participants Needed
Retatrutide for Obesity and Cardiovascular Disease
Chicago, Illinois
This trial is testing a medication called retatrutide in people who have both obesity and heart disease. The study will last over two years to see if the medication is safe and effective.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Recent Heart Events, Type 1 Diabetes, Others
Must Not Be Taking:Weight Loss Drugs
1800 Participants Needed
Liraglutide for Obesity
Chicago, Illinois
This study is for people who have multiple sclerosis, acute leukemia (in remission), or long-COVID and a Body Mass Index over 27 and may struggle with cognitive issues such as remembering information, concentrating, or making decisions that affect everyday life.
By doing this study, researchers hope to learn how liraglutide (Saxenda®), a weight loss drug, affects levels of a certain disease marker in the body called Brain Derived Neurotrophic Factor (BDNF). Participation in this research will last about 21 weeks.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 40
Key Eligibility Criteria
Disqualifiers:Thyroid Cancer, Pancreatitis, Diabetes, Others
Must Not Be Taking:GLP-1 Agonists
30 Participants Needed
Approximately 42% of American adults are obese, and this condition is strongly related to the development of colorectal cancer. Innovative lifestyle strategies to treat obesity and reduce colorectal cancer risk are critically needed. This research will demonstrate that time-restricted eating, a type of intermittent fasting, is an effective therapy to help obese individuals reduce and control their body weight and prevent the development of colorectal cancer.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:45 - 70
Key Eligibility Criteria
Disqualifiers:Renal Disease, Autoimmune Disorders, Cancer, Others
Must Not Be Taking:Weight Loss, Anticoagulants, Antivirals, Immunosuppressants
255 Participants Needed
Time-Restricted Eating for Pregnancy with Obesity
Chicago, Illinois
In the United States, severe obesity (body mass index (BMI) ≥ 40.0 kg/m2) affects approximately 10% of females of reproductive age . Severe obesity is a significant predictor of adverse perinatal outcomes including gestational diabetes mellitus, pre-eclampsia, premature birth, and at its most severe, fetal death, birth defects and a three-fold greater risk of maternal mortality. Observational studies suggest weight maintenance and even modest body fat loss and altering the maternal metabolic milieu (availability of glucose and lipids) in the gestational period may be important to reducing perinatal health risks among pregnant females with severe obesity. The proposed research aims to assess time-restricted eating in the 2nd and 3rd trimesters of pregnancy to explore the effects on maternal weight, and perinatal health outcomes compared to standard clinical care.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 44
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Autoimmune Disorder, Anemia, Others
60 Participants Needed
Exercise Training for Cardiovascular Disease
Chicago, Illinois
The development of type II diabetes (T2D) is strongly associated with obesity and both are well-established risk factors for cardiovascular disease. Knowing that vascular dysfunction is an early event in the development of cardiovascular disease in obese diabetic (OB-T2D) patients, The investigators set their long-term goal to define molecular mechanisms of vascular dysfunction and corrective strategies that target these mechanisms such as physical activity and weight loss. The investigators recently discovered that human adipose tissues release extracellular vesicles (adiposomes) that are efficiently captured by endothelial cells. Adiposomes are known to carry bioactive cargos such as proteins and micro RNAs; however, their lipid content has not been studied nor has their ability to transfer their lipid cargo to endothelial cells. In the current application, the investigators propose to investigate the role of adiposomes in communicating the unhealthy milieu, mainly dysregulated lipids, to endothelial cells in OB-T2D subjects. On top of these lipid species that the investigators propose to be carried by adiposomes are glycosphingolipids (GSLs). These lipids originate from the glycosylation of ceramides, a chemical process that is upregulated in the presence of inflammation and high glucose levels. Preliminary findings showed that in endothelial cells, GSL-rich adiposomes disturb plasma membrane structure and subsequently induce endothelial dysfunction. Moreover, the investigators found that preconditioning endothelial cells with high shear stress (which is an exercise mimetic) protected endothelial cells from the detrimental effects induced by adiposomes. Therefore, the central hypothesis is that adipose tissues in OB-T2D patients release GSL-loaded adiposomes that induce vascular endothelial dysfunction. The researchers propose that exercise and weight loss interventions (bariatric surgery) will restore adipose tissue homeostasis, reduce GSL-loaded adiposomes, and subsequently alleviate vascular risk in OB-T2D patients. The investigators will test the hypotheses by pursuing the following aims: aim 1: Investigate the role of GSL-rich adiposomes in the pathogenesis of endothelial dysfunction in OB-T2D adults; aim 2: Test the effectiveness of exercise training in reducing adiposome-mediated effects on vascular function; and aim 3: Examine changes in adiposome/caveolae axis following metabolic surgery and their association with vascular function.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Chronic Heart, Liver, Kidney Diseases, Others
60 Participants Needed
Why Other Patients Applied
"I am applying for my daughter. She turns 12 this year and is overweight. She's 5'4" and 176 pounds. Would be great to enroll her in a clinical trial to see if this form of care could work for her. Realize that there's no guarantee, but I support her and we'd like to give it a try."
MW
Parent of PatientAge: 46
"I have tried to lose weight, but as I get older, it becomes harder and harder. I have lost weight in the past through diet and exercise, but it has been more difficult to accomplish as I age."
JP
Obesity PatientAge: 44
"I need to lose weight because it's affecting my knees. I've already had a knee replacement and the second one is happening on the left knee in a few months. I've participated in a study in the past for a skin-related issue, and had a good experience. That's why I'm interested in joining a study for wieght loss."
KI
Obesity PatientAge: 69
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"I have a heart condition, and my fat is all in my chest, surrounding my heart. It's hard for me to exercise because my legs are thin and the upper body weight is too much — putting strain on my leg joints. It’s a vicious cycle. I am also post-menopausal, which adds additional weight loss difficulty. I also have stress with being a full time caregiver for my mom. I'm interested in trying a clinical trial."
DK
Obesity PatientAge: 56
Setmelanotide for Obesity
Chicago, Illinois
This is a sub-study of Study RM-493-040 (NCT05774756).
The goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:4+
Key Eligibility Criteria
Disqualifiers:Prader-Willi, ROHHADNET, Severe Psychiatric, Others
39 Participants Needed
Mirikizumab + Tirzepatide for Crohn's Disease
Chicago, Illinois
The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.
The maximum duration of this study is up to 61 weeks.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Type 1 Diabetes, Others
290 Participants Needed
Virtual Intervention for Binge Eating Disorder
Chicago, Illinois
The aim of this project is to pilot test a novel mobile app intervention for adolescents with dysregulated eating behaviors and elevated weight status. This intervention will incorporate evidence-informed strategies targeting self-regulation into cognitive-behavioral treatment for maladaptive eating. Adolescents will use the app for 16 weeks and provide feedback on its usability and effectiveness in managing dysregulated eating.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 19
Key Eligibility Criteria
Disqualifiers:Diabetes, Bulimia Nervosa, Others
Must Not Be Taking:Weight Medications
140 Participants Needed
Lifestyle Modification for High Blood Pressure and Obesity
Chicago, Illinois
Hypertension and obesity are both major risk factors for cardiovascular disease (CVD), a leading cause of death for Black women in the United States. The investigators propose examining the feasibility and acceptability of the 12-week RN-CHeFRx (Real Nourishment and Cooking Healthy Food is Rx) intervention
\- grocery delivery, cooking classes, and nutrition education - for Black women with hypertension and obesity to improve nutritious eating habits and blood pressure control.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Cancer, Liver Disease, Renal Disease, Others
24 Participants Needed
Blood Pressure Cuffs for Hypertension in Pregnancy
Chicago, Illinois
The diagnosis of hypertensive disease during pregnancy is predicated on strict blood pressure thresholds: 140/90 on at least two occasions measured four hours apart for both gestational hypertension and preeclampsia. An improvement in diagnostic accuracy of even 5mm Hg would be significant, as reflected by the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO)consensus for validation of non-invasive blood pressure (NIBP) devices during pregnancy. Given the known inaccuracies of upper arm cylindrical cuff measurements in morbidly obese patients, a conical cuff which provides more accurate measurements will translate into direct patient benefit via more informed diagnosis and management. Fewer women may be exposed to unnecessary treatment, preterm delivery, and/or cesarean section. Recognizing the increasing prevalence of morbid obesity and hypertensive disease amongst pregnant women in the United States, the identification of a more accurate non-invasive cuff is desperately needed. Increasing the accuracy of NIBP measurements on Labor and Delivery has the potential to directly impact the management of tens of thousands of morbidly obese pregnant women diagnosed with hypertensive disease in the United States every year. Establishing the level of agreement between conical forearm and cylindrical upper arm cuffs will shed light on the presence and magnitude of any disparity between measurement methods.
STUDY ENDPOINTS:
Primary Outcome Measures:
* Agreement between conical and cylindrical cuff systolic blood pressure across groups
* Agreement between conical and cylindrical cuff diastolic blood pressure across groups
Secondary Outcome Measures:
• Agreement between conical and cylindrical cuff mean arterial pressure
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Sex:Female
Key Eligibility Criteria
Disqualifiers:Peripheral Arterial Disease, Congenital Heart Disease, Arrhythmia, Pacemaker, Others
110 Participants Needed
Behavioral Intervention for Post-Bariatric Surgery Weight Regain
Chicago, Illinois
The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100).
The main research aims are:
1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control.
2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups.
3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Psychiatric Issues, Substance Abuse, Others
Must Not Be Taking:Weight Loss Medications
200 Participants Needed
Exercise and Weight Loss for Obese PAD Patients
Chicago, Illinois
The PROVE Trial is a randomized clinical trial that will determine whether a weight loss intervention combined with walking exercise achieves greater improvement or less decline in six-minute walk distance at 12 month follow-up than walking exercise alone in people with PAD and BMI\>25 kg/m2. The intervention uses a Group Mediated Cognitive Behavioral framework, connective mobile technology, remote monitoring by a coach, and a calorie restricted Dietary Approaches to Stop Hypertension (DASH)-derived Optimal Macronutrient Intake Trial for Heart Health (OMNIHeart) diet.
212 participants with PAD and BMI \> 25 kg/m2 will be randomized to one of two groups: weight loss + exercise (WL+EX) vs. exercise alone (EX). Participants will be randomized at Northwestern, Tulane University, and University of Minnesota. Our primary outcome is change in six-minute walk distance at 12-month follow-up. Secondary outcomes are change in 6-minute walk distance at 6-month follow-up and change in exercise adherence, physical activity, patient-reported walking ability (measured by the Walking Impairment Questionnaire (WIQ) distance score), and mobility (measured by the Patient-Reported Outcomes Measurement Information System \[PROMIS\] mobility questionnaire) at 12-month follow-up. Tertiary outcomes are perceived exertional effort (measured by the Borg scale at the end of the 6-minute walk at 12-month follow-up), and diet quality. Exploratory outcomes consist of change in the short physical performance battery (SPPB), the WIQ stair climbing and walking speed scores, and calf muscle biopsy measures at 12-month follow-up. Study investigators will perform calf muscle biopsies in 50 participants to compare changes in mitochondrial biogenesis and activity, capillary density, and inflammation between WL+EX vs. EX.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Amputation, Major Surgery, Cancer, Others
Must Not Be Taking:Weight Loss Medications
212 Participants Needed
Semaglutide + Low-Dose Insulin Glargine for Type 2 Diabetes
Chicago, Illinois
This study compares semaglutide, together with a lower dose of insulin glargine, to a higher dose of insulin glargine in participants with type 2 diabetes. The study looks at how well the study medicines control blood glucose levels. Participants will either get semaglutide together with a lower dose of insulin glargine or a higher dose of insulin glargine. The study will last for about 47 weeks (approximately 11 months). Participants will have 9 clinic visits, 15 phone/video calls and 1 home visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 2 periods of 10 days during the study.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Not Listed
568 Participants Needed
Time Restricted Eating for Polycystic Ovary Syndrome
Chicago, Illinois
Background: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility among young women. This syndrome is a reproductive and endocrinological disorder that affects up to 18% of reproductive-aged women. To date, the only strategy shown to reverse PCOS is sustained weight loss of 5-10%. At present, daily calorie restriction (CR) is the main diet prescribed to patients with PCOS for weight loss. However, some women find it difficult to adhere to CR because calorie intake must be vigilantly monitored every day. Considering these problems with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This diet is called "time restricted eating" (TRE) and involves confining the period of food intake to 6-8 h per day. TRE allows individuals to self-select foods and eat ad libitum during a large part of the day, which greatly increases compliance to these protocols. Recent findings show that TRE significantly reduces body weight, insulin resistance, and inflammation in adults with obesity. However, no randomized controlled trials have studied the role of TRE in treating PCOS.
Accordingly, this study will compare the effects of TRE vs CR in females with PCOS over 6 months on body weight, androgen markers, inflammatory markers and insulin sensitivity.
Methods: A 6-month randomized, controlled, parallel-arm trial will be implemented. Females with obesity and PCOS will be randomized to 1 of 3 groups: (1) 6-h TRE (ad libitum food intake from 1-7 pm, fasting from 7pm-1pm); (2) CR (25% energy restriction daily); or (3) control group (ad libitum intake with no meal timing restrictions).
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Age:18 - 40
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Listed
300 Participants Needed
CagriSema for Type 2 Diabetes and Obesity
Chicago, Illinois
This trial tests if the new medicine CagriSema can help people with excess body weight and type 2 diabetes lose weight. Participants will receive either CagriSema or another treatment. The study will last about a year and a half. Cagrilintide and semaglutide are both being investigated for weight management.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
1200 Participants Needed
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