Clinical trials on Obesity

Understanding Obesity: A Comprehensive Overview

Obesity is a complex health condition characterized by an excessive amount of body fat. It is not merely a cosmetic concern but a medical problem that increases the risk of other diseases and health problems, such as heart disease, diabetes, high blood pressure, and certain cancers. The root causes of obesity are multifaceted, involving a combination of genetic, behavioral, metabolic, and hormonal influences on body weight. The balance between calorie intake and energy expenditure determines an individual’s weight. When a person consumes more calories than they burn, they gain weight, leading to obesity if the pattern continues over time.

Assessing obesity often involves measuring Body Mass Index (BMI), a simple index of weight-for-height that is commonly used to classify overweight and obesity in adults. It is defined as a person’s weight in kilograms divided by the square of his height in meters (kg/m2). However, it’s important to note that BMI is a screening tool, not a diagnostic of the body fatness or health of an individual. Other factors such as waist circumference, the distribution of fat around the body, and the individual’s health conditions also play critical roles in determining the risk associated with obesity.

Addressing obesity requires a holistic approach that includes lifestyle changes, such as eating healthier foods, increasing physical activity, and implementing behavioral changes to sustain these practices. In some cases, medications or surgery may be recommended as part of the treatment plan. The goal is not only weight loss but also the prevention of weight regain and the improvement of overall health. With the right support and treatment plan, individuals can overcome obesity and lead healthier, more fulfilling lives.

Prognosis for Obesity: Understanding Long-Term Outcomes

Obesity is a chronic health condition characterized by excessive body fat accumulation that may impair health. The long-term prognosis for those with obesity can vary significantly based on several factors, including the degree of obesity, age, genetic predispositions, and the presence of obesity-related health conditions. Generally, obesity is associated with an increased risk of developing serious health issues such as type 2 diabetes, hypertension, cardiovascular diseases, certain types of cancer, and sleep apnea, which can potentially reduce life expectancy and quality of life. The progression of these conditions over time can lead to further health deterioration if not managed effectively. Moreover, obesity can impact mental health, contributing to conditions like depression and anxiety. It is important to note that the prognosis can improve with interventions that lead to sustained weight loss and lifestyle changes, although these are not discussed here. The prognosis can vary widely, and healthcare professionals can provide personalized information based on a specific health profile.

Complications in Obesity: Understanding the Risks

Obesity may lead to a range of complications that significantly impact health and quality of life. A major concern is cardiovascular disease, including high blood pressure, heart attacks, and strokes, which may arise from the extra strain placed on the heart and blood vessels. Additionally, there is an increased risk of type 2 diabetes due to the effect on how the body processes sugar.

  • Joint problems, such as osteoarthritis, are also common because of the excess weight bearing down on the hips, knees, and ankles, potentially leading to chronic pain and mobility issues.
  • Sleep apnea, a condition characterized by the repeated stopping and starting of breathing during sleep, is more prevalent in cases of obesity, often resulting in fatigue and other health problems.
  • Furthermore, there is a contribution to certain types of cancer, including breast, colon, and endometrial cancer, due to obesity.
  • The psychological effects, such as depression and anxiety, can also diminish overall well-being, affecting both mental and social aspects of life.

Treatment Methods for Obesity

In managing obesity, lifestyle modifications are crucial. A balanced diet rich in fruits, vegetables, lean proteins, and whole grains, while low in processed foods and sugars, supports weight loss. Regular physical activity, including both aerobic exercises like walking or swimming and strength training, is recommended to burn calories and build muscle.

Pharmacotherapy may be advised for some individuals. Medications that suppress appetite or reduce fat absorption can be prescribed, always under medical supervision to ensure safety and effectiveness.

Modern technology also offers innovative solutions. Mobile apps for tracking food intake and physical activity help maintain accountability. Wearable devices monitor heart rate and calories expended, providing real-time feedback and motivation.

These treatment methods, when combined, can significantly contribute to weight management and overall health improvement. Commitment and consistency in applying these strategies are key to achieving long-term success in the fight against obesity.

  • CT-EU-00112464

    Testing setmelanotide for weight loss in genetic obesity

    This study is a research project looking into the effectiveness of a medication called setmelanotide for people who are dealing with obesity due to specific genetic variations. This medication is given under the skin. The study is designed to see if setmelanotide can help people lose weight compared to a placebo, which don’t contain any active medication.

    The study focuses on individuals who have one of several gene variants in the Melanocortin-4 Receptor pathway. These variants include changes in the POMC or PCSK1 genes, the LEPR gene, the SRC1 gene, or the SH2B1 gene. Depending on which gene variant a participant has, they will be placed into one of four sub-studies.

    The main goal of this clinical trial is to measure how much weight participants lose while taking setmelanotide over a period of 52 weeks. This will be compared to the weight loss of participants who receive the placebo. The study is carefully controlled and blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo until the study is completed.

    This trial is an important step in understanding how setmelanotide can help people with obesity linked to specific genetic factors, offering hope for a targeted treatment option.

    • Setmelanotide
    • Placebo
  • Improving Heart Health with a Personalized Plant-Based Diet

    The PRE-CARE-DIET study is focused on understanding how a personalized, plant-based diet that’s rich in substances called (poly)phenols can impact your heart health and metabolism. These (poly)phenols are common in fruits, vegetables, and some other foods, and they might play a big role in keeping your heart healthy. However, not everyone’s body handles these (poly)phenols the same way. This study aims to figure out if these differences affect how well the diet works.

    To start, we’re looking to include 330 people who are at risk for heart and metabolic issues. Before you join the experimental part of the study, we’ll ask you to take a special test that involves drinking a (poly)phenol-rich beverage. This will help us understand how your body processes these compounds. Based on this, you’ll be grouped with others who process (poly)phenols similarly.

    During the study, if you’re in the treatment group, we’ll slightly adjust your diet to increase your (poly)phenol intake by 50%, ensuring you get at least 500 mg daily. Don’t worry, we’ll make these changes without drastically altering your usual eating habits. If you’re in the control group, your diet will stay the same. We’re interested in seeing how these changes affect your heart health and metabolism over time.

    We’ll check in on your health through a few visits, focusing on your heart health risk over the next 10 years. This will be done using a method called the Systematic Coronary Risk Estimation, which might sound complicated, but it’s just a way to understand your risk for heart disease in the future. We’ll do this twice during the study, once after 8 weeks and again after 24 weeks, to see how the diet is working for you.

    This study is not just about changing diets; it’s about understanding how a personalized diet could help manage or reduce the risk of heart disease and metabolic issues, based on how your body handles certain nutrients. Your participation could help us learn how to better tailor dietary recommendations to individual needs, potentially making a big difference in heart health management.

  • Investigating the role of testosterone undecanoate in reducing liver fat in men with diabetes

    A 52-week trial is being conducted to assess the potential of Testosterone Undecanoate in aiding overweight men with type 2 diabetes or prediabetes. The focus is on evaluating its effectiveness in reducing liver fat, a factor associated with these conditions and other heart diseases. Following the initial 52 weeks, an additional 108 weeks of observation will be undertaken to ascertain any long-term benefits of the medication. The hypothesis posits that Testosterone Undecanoate may mitigate these conditions by diminishing liver fat accumulation.

    • Testosterone Undecanoate
  • Studying CagriSema’s effects on kidney damage in diabetes and obesity

    This clinical trial explores the effectiveness of CagriSema, a new medication, in reducing kidney damage in adults with chronic kidney disease (CKD), type 2 diabetes (T2D), and overweight or obesity. The goal is to see if this drug can help reduce damage to the kidneys. CagriSema will be compared to two other medicines, semaglutide and cagrilintide, and to placebo. The trial is randomized and double-blind, ensuring neither participants nor researchers know who receives which medication.

    • Semaglutide
    • Cagrilintide
  • A comprehensive evaluation of retatrutide in obesity and associated comorbidities

    This study evaluates the effectiveness and safety of a new drug, retatrutide, in individuals with obesity or overweight, including those with knee osteoarthritis or obstructive sleep apnea. Lasting about 89 weeks, the trial involves randomized assignment of participants to either receive retatrutide or a placebo. The main goals are to observe changes in body weight, knee pain in osteoarthritis, and sleep apnea severity. The study also examines various secondary outcomes like changes in BMI, waist circumference, and blood pressure. The trial aims to provide new insights into weight management and associated health conditions, offering hope for improved treatments.

    • Retatrutide
  • Investigating tirzepatide for kidney disease in overweight people

    In this study, an investigation is being conducted on a medication known as tirzepatide, or LY3298176. The objective is to assess its potential benefits for individuals dealing with overweight or obesity and a chronic kidney condition, which may or may not be associated with type 2 diabetes. The applicability of tirzepatide for individuals in both scenarios is of interest. A specialized imaging technique called BOLD MRI will be utilized to observe kidney activity. The study is designed to span approximately 56 weeks, with participants being requested to attend up to 12 visits in total.

    • Tirzepatide/LY3298176
  • Study of the trial on weight loss and type 2 diabetes control of retatrutide

    This study involves a new drug called Retatrutide (LY3437943). It is intended for people who suffer from a type of sugar disease called type 2 diabetes and are also slightly or very overweight. This disease can lead to many health problems, so it is important to find good treatment. Scientists want to see if this new drug can help people with type 2 diabetes and who are overweight. They also wish to check whether it is safe for these people to take the drug. Some people in the study will have another health issue called obstructive sleep apnea, which occurs when a patient stops breathing for a short period of time while sleeping. Treatment lasts approximately 89 weeks and requires as many as 24 clinic visits. Scientists will measure the amount of the new drug in the bodies of people taking part in the study, and will also look at the drug’s effect on a range of health outcomes.

    • Retatrutide
  • Testing orforglipron for obesity & type 2 diabetes

    A drug called Orforglipron is being tested. This study is for adults who are overweight or have a disease called type 2 diabetes. The purpose of this study is to see if this medicine can safely help people lose weight. Some patients will receive orforglipron once a day, the rest will receive a placebo. All patients will be monitored to see how their weight changes. The study will last 77 weeks.

    • Orforglipron
  • Study on the impact of Retatrutide for overweight patients with kidney disease

    This study is exploring a new treatment for individuals who are overweight or have obesity and suffer from chronic kidney disease, with or without Type 2 Diabetes. It tests a medication called Retatrutide (LY3437943), aiming to improve kidney function. Participants will either receive LY3437943 or a placebo in a controlled and monitored environment. The study spans approximately 31 weeks, involving regular health check-ups and tests to monitor the medication’s effects on kidney function. The goal is to find an effective treatment that can enhance kidney health in patients with these conditions. The study is particularly important for advancing understanding and treatment options for those struggling with kidney issues related to weight and diabetes.

    • Retatrutide
  • Testing retatrutide’s effect on obesity and knee osteoarthritis

    This research is about a new medication called Retatrutide (LY3437943), which will be taken once a week by people who are overweight or suffer from obesity, and also have a condition where their knee hurts due to wear and tear, known as osteoarthritis of the knee. This is a third phase study, where we test how well the drug works and how safe it is. Unlike some studies, participants will not know whether they are taking the medication or a placebo (a pill that looks the same but doesn’t contain the medication). The study will last about 77 weeks.

    • Retatrutide
  • Comparing orforglipron and insulin glargine for type 2 diabetes and obesity or overweight

    In this study, the drug orforglipron is being tested against the common insulin medication known as Insulin Glargine. Specifically, individuals with type 2 diabetes who are overweight or obese, and therefore at a higher risk of heart problems, are included in this research. The objective of the study is to assess the safety and effectiveness of orforglipron compared to insulin glargine. Visits to the research center, up to 27 times over a two-year period, will be required. Monitoring for serious heart-related events such as heart attacks, strokes, hospitalizations for chest pain will be conducted by the investigators. Additionally, changes in diabetes and blood sugar levels over time will be analyzed.

    • Insulin Glargine
    • Orforglipron
  • Study examining how tirzepatide helps adults who are overweight

    The study focuses on tirzepatide, a new treatment option for adults suffering from obesity. The study aims to understand how this drug may help improve overall health and reduce the risk of diseases commonly associated with obesity. Participants will receive Tirzepatid and will closely monitor their health progress, watching for changes in weight, heart health and other key health indicators. The aim of the study is to thoroughly understand the potential benefits and safety of tirzepatide in improving the quality of life of people with obesity.

    • Tirzepatide
  • Testing semaglutide’s success in children’s weight control

    This research is about a medicine named Semaglutide. It’s being studied to see if it can help children and teenagers with excess body weight lose weight. The medicine is given by an injection (like a shot) under the skin once a week. Researchers will check whether if it’s safe for kids (aged 6 to 17) to use for a long time.

    • Semaglutide
  • Studying retatrutide for treating obesity and heart disease

    This research study is about a medicine called Retatrutide (also known as LY3437943), which will be tested on people who have obesity and heart disease. The way this study will work is that some people will be given Retatrutide once a week, while others will be given a placebo, which doesn’t have any medicine in it. By doing this, the researchers can see if Retatrutide helps to improve health and if it is safe to use. The study will run for just over two years. AUC is a way for the study to measure the effect of Retatrutide on your body.

    • Retatrutide
  • Study on a new treatment for obesity: distal jejunal-release dextrose

    This clinical trial is a phase II study exploring the effectiveness and safety of a new treatment for obesity called distal jejunal-release dextrose (APHD-012). The trial aims to enroll 150 adult obese participants, both male and female, aged between 18 and 70 years, with or without endocrine and/or metabolic conditions. Cohort 1 will receive the study medication once daily for 12 months, while Cohort 2 will receive the medication once daily for only 6 months. The study’s primary goal is to determine the efficacy and safety of distal jejunal-release dextrose in helping obese individuals lose weight and improve their overall health.

    • APHD-012