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105 Obesity Trials near Yuma, AZ
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 PowerBlueberries for Weight Loss
San Diego, California
The objective is to complete a two-phase study to assess how wild blueberries impact regulation of appetite of overweight and obese men and women as well as to determine if wild blueberries can promote more effective weight loss than an isocaloric control. For phase I, the acute effects of consuming 1-cup of frozen wild blueberries mixed into ¾ C of low-fat yogurt will be compared to consuming an isocaloric serving of yogurt mixed with an artificially flavored and colored blueberry syrup. During acute testing, subjective ratings of appetite, glucose metabolism, and appetite-regulating hormones will be assessed. Phase II will consist of an 8-week feeding trial in which the same subjects will consume daily servings of yogurt mixed with either frozen wild blueberries or placebo syrup along with intensive counseling for weight loss. The hypothesis is that wild blueberries will reduce hunger by regulating appetite hormones and promoting beneficial glycemic and insulinemic responses and that daily consumption of wild blueberries will translate to improved adherence to a weight loss regimen and therefore greater weight and fat loss. Secondary aims for Phase II of this project will include exploring the impacts of blueberry consumption during weight loss on antioxidant status, inflammatory markers, blood lipid profiles, glucose status, dietary intake, physical activity and blood pressure.
Trial Details
Trial Status:Active Not Recruiting
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Not Listed
40 Participants Needed
Setmelanotide for Obesity
San Diego, California
This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:2+
Key Eligibility Criteria
Disqualifiers:Melanoma, Depression, Pregnancy, Others
Must Be Taking:Setmelanotide
30 Participants Needed
Physical Activity for Heart Disease and Obesity Prevention
San Diego, California
This study has the goal to increase physical activity and fitness among Latinos in San Diego, California and Mexicali, Baja California (U.S.-Mexico border) since these cities have similar diseases such as high rates of heart disease and obesity. Therefore there is a need to have physical activity programs for children and their families. We will collaborate with community centers to have this program available.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6+
Key Eligibility Criteria
Disqualifiers:Medical Condition Contraindicated To Exercise
290 Participants Needed
Maridebart Cafraglutide for Obesity
San Diego, California
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Pancreatitis, Severe Psychiatric Disorder, Others
1105 Participants Needed
Auto-EPAP for Airway Blockage
San Diego, California
To evaluate the safety and effectiveness of the Automatic Expiratory Positive Airway Pressure (Auto-EPAP) feature versus manual expiratory positive airway pressure (EPAP) in the Vivo 45 LS Ventilator.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Oxygen Therapy, Invasive Interface, Others
20 Participants Needed
Cagrilintide for Obesity and Type 2 Diabetes
La Jolla, California
This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Others
Must Be Taking:Oral Antidiabetics
330 Participants Needed
Negative Affect Task for Binge Eating Disorder
San Diego, California
Binge-eating is characterized by recurrent episodes of eating large amounts of - typically high calorie - foods, eating much more rapidly than normal and until feeling uncomfortably full, as well as feeling disgusted with oneself, depressed, or guilty after those episodes. Two eating disorders are characterized by binge-eating as central diagnostic criteria, binge-eating disorder (BED) and bulimia nervosa (BN). Binge-eating episodes in BN, but not BED, are typically followed by compensatory mechanisms such as self-induced vomiting, and BED is typically associated with obesity, while BN is not. Behavior studies such as ecological momentary assessment (EMA) research of affect in an individual's naturalistic environment have shown that negative affect and negative urgency (the tendency to act rashly when distressed) often precede binge-eating.
The Investigators want to answer the following questions: Can negative affect in BN and BED be linked to 1) altered dopamine related brain reinforcement learning, 2) to food value computation and cognitive control circuit function, and 3) can dopamine related brain activation predict eating and negative affect, indicating a brain based neurobiological vulnerability. Answering those questions will help to define binge-eating based on regulation of brain reward, cognition, and emotion circuit function and point toward potential psychopharmacological interventions to normalize brain function and behavior.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 55
Key Eligibility Criteria
Disqualifiers:Pregnancy, Bipolar, Psychosis, Others
Must Not Be Taking:Psychostimulants, Others
410 Participants Needed
PBT-EF for Obesity and ADHD
San Diego, California
This trial is testing a new program that helps parents teach their overweight or obese children with ADHD how to manage their weight and improve their behavior. The program includes special training to help kids focus better and control their impulses. The goal is to make it easier for these children to stick to healthy habits. Parents focused CBT can be considered as a complementary treatment for reducing ADHD symptoms and BMI and increased self-esteem in the obese ADHD children.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12
Key Eligibility Criteria
Disqualifiers:Weight Control Program, Suicidality, Psychosis, Others
Must Not Be Taking:Weight Loss Medications
30 Participants Needed
Comprehensive Weight Loss Program for Obesity
La Jolla, California
The objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Diabetes, Coronary Heart Disease, Bulimia, Others
Must Not Be Taking:Weight Loss Medications
300 Participants Needed
Time-Restricted Eating for Obesity
La Jolla, California
In a randomized controlled trial, the investigators intend to measure the health impact of time-restricted eating (TRE) in obese patients (body mass index (BMI) ≥ 30 kg/m2), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutritional counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 10-hour eating window for 12 weeks (TRE).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Diabetes, Pregnancy, Heart Failure, Others
Must Not Be Taking:Insulin, Anti-diabetics, Appetite Suppressants, Others
61 Participants Needed
Family-Based Obesity Intervention for Mexican Americans
La Jolla, California
Mexican American families share similar elevated risks for obesity and obesity-related conditions, such as type 2 diabetes. Because negative family interactions and relationships (e.g., poor communication, high conflict, low emotional closeness) are associated with obesity treatment outcomes, this study tests a behavioral weight management intervention that provides relationship skills counseling to mothers and adult daughters. The goal is to improve family interaction patterns to buffer challenges and strengthen collaboration for eating and physical activity behaviors that support long-term weight management and thus provide an effective obesity treatment approach to address a major public health concern.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:Female
Key Eligibility Criteria
Disqualifiers:Pregnancy, Physical Limitations, Weight Loss Surgery, Others
236 Participants Needed
Behavioral Treatments for Childhood Obesity
La Jolla, California
The objective of this proposed study is to compare Regulation of Cues (ROC), Family-Based Treatment (FBT), ROC+ nutrition education and reducing energy intake (ROC+) and a health education comparator (HE) for children with overweight or obesity who are high on food responsiveness (FR).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:7 - 12
Key Eligibility Criteria
Disqualifiers:Acute Psychiatric Disorders, Type 1 Diabetes, Others
Must Not Be Taking:Weight Loss Medications
280 Participants Needed
Time-Restricted Eating for Obesity
La Jolla, California
In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Pregnancy, Cardiovascular Events, Others
Must Be Taking:Cardiovascular Medications
180 Participants Needed
Behavioral Therapy + Support for Caregivers
La Jolla, California
The objective of this proposed study is to collect initial efficacy data on a telehealth family-based behavioral program for Latino children with overweight or obesity, which also includes additional caregiver support (PBT-AC), compared with health education (HE).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:5 - 12
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Severe Autism, Others
Must Not Be Taking:Insulin, Weight Loss Medications
167 Participants Needed
Telehealth Program for Autism
La Jolla, California
The objective of this proposed study is to collect initial efficacy data on a telehealth parent-based behavioral program for children with autism and overweight or obesity (PBT-A), compared with health education (HE).
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:6 - 12
Key Eligibility Criteria
Disqualifiers:Chronic Physical Disease, Anorexia, Bulimia, Others
Must Not Be Taking:Weight Loss Medications
150 Participants Needed
Time-Restricted Eating for Liver Cancer
La Jolla, California
This is a feasibility study that will collect data to assess the potential effect of a nutritional intervention designed to improve liver metabolism. This prospective single-site trial will enroll adult patients undergoing liver-directed therapies for hepatocellular carcinoma. Eligible individuals who are randomized to the intervention group will be enrolled in a six-month nutritional change program consisting of time-restricted eating in which calorie consumption is limited to 8-10 hours during the day, plus targeted healthy changes in what they eat. The intervention includes dietary counseling visits with a study registered dietitian and motivational phone calls with a study Certified Health and Wellness Coach to help subjects adhere to the intervention. Individuals in the control group will be enrolled in a six-month period of observation only. The main questions it aims to answer are:
Is a prolonged nightly fast coupled with a healthy diet safe and feasible for patients with liver cancer? Does the intervention improve liver metabolism?
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Advanced HCC, Cirrhosis, Diabetes, Others
Must Not Be Taking:Metabolic Biomarkers
50 Participants Needed
Mirabegron for Obesity
La Jolla, California
This study will examine the gene expression of the adrenergic Beta-3 receptor (ADRB3) regulation in human subcutaneous adipose tissue before and after treatment with mirabegron, an ADRB3 agonist. Gene expression will be compared across two groups, lean and obese participants. There will be a total of three study visits: Screening/Eligibility, Pre-Dose Adipose Tissue Biopsy and Post-Dose Adipose Tissue Biopsy. Participants will be given a single dose of 100mg oral mirabegron on the day of the Post-Dose Adipose Tissue Biopsy.The trial design is a single-center, phase 1, open-label, exploratory study to examine the adipocyte gene expression in adults treated with 1 dose of 100mg oral mirabegron.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Diabetes, Pregnancy, Heart Disease, Others
Must Not Be Taking:Anticoagulants, Appetite Suppressants, Corticosteroids, Others
40 Participants Needed
Setmelanotide for Obesity
Phoenix, Arizona
The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway:
* POMC or PCSK1 (Sub-study 035a)
* LEPR (Sub-study 035b)
* SRC1 (Sub-study 035c)
* SH2B1 (Sub-study 035d)
The objectives and endpoints are identical for these sub-studies.
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:6 - 65
Key Eligibility Criteria
Disqualifiers:Psychiatric Disorders, Suicidal Ideation, Pulmonary, Cardiac, Endocrine, Others
400 Participants Needed
Tirzepatide for Psoriasis and Obesity
Phoenix, Arizona
The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.
The study will last up to 12 months.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Type I Diabetes, Pancreatitis, Thyroid Cancer, Others
Must Be Taking:Ixekizumab
200 Participants Needed
Metabolic Surgery for Non-Alcoholic Fatty Liver Disease
Phoenix, Arizona
Metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as non-alcoholic fatty liver disease (NAFLD), a major global public health concern, is commonly associated with obesity, diabetes, and dyslipidemia. MASLD is currently the most common cause of chronic liver disease affecting about 80% of people with obesity, ranging from simple fat deposits in the liver to Metabolic Dysfunction-Associated Steatohepatitis (MASH), cellular injury, advanced fibrosis, cirrhosis, or hepatocellular carcinoma. Patients with MASH are also at risk for cardiovascular disease and mortality. There is no universally approved medication for MASH. Weight loss remains the cornerstone of MASH treatment.
Patients meeting the inclusion and exclusion criteria and who give informed consent will be enrolled in the trial and undergo the baseline liver biopsy (if none available). Approximately 120 patients with MASH and liver fibrosis (F1-F4 in baseline liver biopsy) will be randomized in a 1:1 ratio to metabolic surgery or medical treatment (incretin-based therapies ± other medical therapies for MASH) and followed for 2 years at which time a repeat liver biopsy will be performed for the assessment of the primary end point.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Chronic Liver Diseases, Type 1 Diabetes, HIV, Others
Must Not Be Taking:Semaglutide, Tirzepatide, Liraglutide, Others
120 Participants Needed
Why Other Patients Applied
"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
"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 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 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 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
Aleniglipron for Obesity
Phoenix, Arizona
This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Diabetes, Recent Weight Change, Others
71 Participants Needed
RGT001-075 for Obesity
Phoenix, Arizona
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.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Diabetes, Pancreatitis, Gallbladder Disease, Others
Must Not Be Taking:GLP-1 Analogs
236 Participants Needed
LY3549492 for Obesity
Phoenix, Arizona
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of LY3549492 in adults with obesity or overweight. Participation in the study will last about one year.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Diabetes, Pancreatitis, Renal Impairment, Others
275 Participants Needed
LY3841136 + Tirzepatide for Obesity with Type 2 Diabetes
Phoenix, Arizona
The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Severe Hypoglycemia, Cardiovascular Conditions, Renal Impairment, Others
Must Be Taking:Metformin, SGLT2 Inhibitors
350 Participants Needed
AZD6234 for Obesity
Phoenix, Arizona
A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Cushing's, Prader-Willi, Bariatric Surgery, Others
Must Not Be Taking:Weight Loss Medications
262 Participants Needed
AMG 133 for Obesity With or Without Type 2 Diabetes
Phoenix, Arizona
This trial is testing AMG 133, a new drug, to see if it helps people lose weight and keep it off. It targets overweight or obese individuals, both with and without Type 2 diabetes. The drug may work by affecting metabolism or appetite.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pancreatitis, Thyroid Carcinoma, Psychiatric Disorders, Others
Must Be Taking:Metformin, Sulfonylureas, SGLT2 Inhibitors
592 Participants Needed
Meal Testing for Healthy Subjects
Phoenix, Arizona
Background:
Researchers use mixed meal tolerance tests (MMTTs) to look at how people s bodies respond to eating a meal. However, researchers do not agree on how to decide the number of calories to give in each meal. Some use fixed meals, which are the same size for everyone, and some use adjusted meals, based on the size of the person s body. Researchers want to know which MMTT is best to use for future research.
Objective:
To learn how fixed vs adjusted meals affect blood glucose levels in healthy people.
Eligibility:
Healthy people aged 18 years or older.
Design:
Participants will have 3 or 4 clinic visits of up to 8 hours in 8 weeks.
Participants will have baseline tests:
Their height, weight, and waist size will be measured.
They will have an oral glucose tolerance test: A needle attached to a tube (IV) will be inserted into a vein in the arm. They will have a sugary drink. Blood samples will be taken from the tube at intervals up to 3 hours after the drink.
They will have a body scan.
Participants will have 2 MMTT visits. One will include a fixed meal and one will include an adjusted meal. They will have tests at both visits:
Resting metabolic rate: A clear hood will be placed over the participant s head while they rest for 20 minutes. This will measure the oxygen they breathe in and out.
MMTT. Participants will have 5 minutes to drink a liquid meal. Blood samples will be taken at intervals for the next 4 hours....
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Diabetes, Anemia, Pregnancy, Alcohol Abuse, Others
Must Not Be Taking:Metabolism-altering Drugs
79 Participants Needed
Caloric Intake Changes for Diet-Induced Thermogenesis in Obesity
Phoenix, Arizona
Background:
Diet-induced thermogenesis (DIT) is the amount of energy one s body uses to eat food, absorb the nutrients from the food, and process those nutrients. Researchers would like to understand more about how changing the balances of protein, fat, carbohydrates, and total calories in the diet can affect DIT.
Objective:
To learn how different diets can change a person s DIT.
Eligibility:
Healthy people aged 18 to 60 years who have not intentionally lost weight in the past 6 months.
Design:
Participants will stay in a clinic for about 35 days. They will eat only the food provided. They will receive 8 different diets during the study, including 7 test diets.
Participants will undergo multiple tests.
They will be screened with blood and urine tests and a test of their heart function.
During the first few days:
Their waist, thigh, and neck circumference will be measured.
They will have a DXA scan: They will lie on a padded table for about 20 minutes while an instrument measures the amount of fat in their body.
They will be tested for diabetes.
They will answer questionnaires about topics including eating behavior, hunger, and stress.
Throughout the study:
Their weight will be measured daily.
Blood tests will be repeated.
They will stay in a metabolic chamber a total of 9 times. They will remain in a closed room for 24 hours while researchers monitor the room temperature and levels of oxygen and carbon dioxide. Participants will collect all their urine for each 24-hour period.
...
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 60
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Cardiovascular, Others
Must Not Be Taking:Energy Metabolism Drugs
120 Participants Needed
Revita DMR for Obesity
Phoenix, Arizona
Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Patients who previously lost at least 15% of their body weight on a GLP-1 can qualify for the open label REVEAL-1 cohort. The data generated from the REVEAL-1 cohort will be used for open label reporting as the study progresses. The REMAIN-1 randomized cohort will enroll patients living with obesity and a body mass index ("BMI") between 30 and 45 kg/m2 who are not currently on a GLP-1 drug. Patients will be prescribed tirzepatide and titrated to achieve at least 15% total body weight loss, at which time tirzepatide will be discontinued and patients will be randomized to Revita versus sham at 2:1.
Midpoint Analysis of Randomized Cohort:
The midpoint analysis of the randomized cohort will be performed at three months of follow-up on approximately 45 patients, allowing us to assess and report on safety and efficacy signals that could be anticipated in the pivotal analysis. These patients are distinct from those included in the pivotal analysis.
Pivotal Analysis of Randomized Cohort:
The pivotal analysis of the randomized cohort will be performed on approximately 315 patients (distinct from those included in the midpoint analysis) and will evaluate safety and efficacy in the first co-primary endpoint, which is weight regain from the time of tirzepatide discontinuation in Revita DMR versus sham patients at six months, with a primary objective of demonstrating a benefit of Revita DMR versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita DMR treated group at one year to demonstrate the durability of the Revita DMR procedure for weight maintenance after discontinuation of a GLP-1-based therapy.
Secondary objectives will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease ("CVD") risk factors, body composition and pre-diabetes status. All patients enrolled in the study will receive diet and lifestyle counseling.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:21 - 70
Key Eligibility Criteria
Disqualifiers:Diabetes, Pancreatitis, Substance Abuse, Others
Must Be Taking:Tirzepatide
315 Participants Needed
Macupatide + Eloralintide for Obesity
Phoenix, Arizona
The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity or overweight and with type 2 diabetes. Participation in the study will last about 48 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Cardiovascular Conditions, Malignancy, Others
Must Be Taking:Metformin, SGLT2 Inhibitors
200 Participants Needed
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