Obesity – Trials in Disease

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Ongoing Clinical Trials for Obesity

There are currently 64 ongoing clinical trials investigating various treatments for obesity. These studies are testing medications including semaglutide, tirzepatide, retatrutide, and other novel compounds, examining their effects on weight loss, metabolic health, and related conditions in diverse patient populations ranging from children to adults with various obesity-related complications.

Clinical trial locations

Study of esomeprazole effects on endoscopic sleeve gastroplasty structural integrity in obese patients

This trial investigates how a proton pump inhibitor medication affects the long-term success of endoscopic sleeve gastroplasty, a minimally invasive weight loss procedure. The study examines whether taking esomeprazole after the procedure impacts how well the stomach maintains its reduced size over time.

Main inclusion criteria: Participants must be adults between 20 and 65 years old with a body mass index between 30 and 45. They must be willing to undergo the endoscopic sleeve gastroplasty procedure and be capable of providing informed consent independently.

Main exclusion criteria: Patients cannot participate if they have active stomach ulcers, previous stomach or weight loss surgery, uncontrolled diabetes, severe heart or lung disease, blood clotting disorders, or active substance abuse.

Study focus: The research aims to determine whether acid-reducing medication affects the structural integrity of the stomach procedure over 12 months, monitoring whether the stomach maintains its new shape and size.

Investigational drugs: The study uses esomeprazole, a proton pump inhibitor that reduces stomach acid production, administered both intravenously and orally at a maximum daily dose of 80 mg for up to 8 weeks.

Study of Orforglipron for Weight Management in People with Obesity or Overweight, With or Without Type 2 Diabetes

This trial tests orforglipron, an oral medication taken once daily, to determine its effectiveness in weight management for individuals with elevated body mass index. The study includes two separate groups: those without diabetes and those with type 2 diabetes, each receiving treatment for 40 weeks.

Main inclusion criteria: Participants must have a body mass index of 30 or higher (or 27 or higher with weight-related health conditions), be aged 18-70 years, and have made at least one previous unsuccessful diet attempt. Those in the diabetes study group must have hemoglobin A1c levels between 7% and 10%.

Main exclusion criteria: Individuals with bipolar disorder, schizophrenia, uncontrolled medical conditions, recent major depressive episodes, or those who are pregnant, breastfeeding, or participating in other trials cannot join.

Study focus: The research evaluates how well orforglipron reduces body weight compared to placebo in people without diabetes, and how it improves blood sugar control in those with diabetes, with both groups receiving the treatment alongside lifestyle interventions.

Investigational drugs: Orforglipron tablets are taken once daily, working as a GLP-1 receptor agonist to reduce appetite and help with weight loss through mimicking natural hormones that regulate hunger and satiety.

Study of Semaglutide for Weight Loss in Obesity Patients with Low Response After Bariatric Surgery

This research examines whether semaglutide injections can help patients who have not lost sufficient weight following bariatric surgery. The 68-week study compares outcomes in participants receiving the medication with lifestyle guidance versus lifestyle guidance alone.

Main inclusion criteria: Participants must be adults who underwent gastric bypass or sleeve gastrectomy surgery with a pre-surgery body mass index of 35 or higher, and must have regained more than 5% of their weight after reaching their lowest post-surgery weight.

Main exclusion criteria: The study excludes individuals who are not low responders after bariatric surgery, those unwilling to follow lifestyle interventions, those unable to take semaglutide, and members of vulnerable populations.

Study focus: The trial investigates whether combining semaglutide with lifestyle support leads to greater weight loss than lifestyle support alone in patients who have experienced inadequate weight loss or weight regain following bariatric surgery.

Investigational drugs: Semaglutide is administered as a 2.4 mg weekly injection that mimics GLP-1 hormones to control appetite and reduce food intake, potentially aiding weight loss in bariatric surgery patients with insufficient results.

Study of semaglutide treatment for adolescents with obesity caused by antipsychotic medications

This trial studies semaglutide treatment in young people aged 12-18 who have developed weight problems as a side effect of antipsychotic medications. The 26-week study examines whether the medication can help reduce body weight and improve body composition in this specific patient group.

Main inclusion criteria: Participants must be aged 12-18 years, have a body mass index above the 90th percentile for their age and sex, body fat percentage above the 95th percentile, and be on stable antipsychotic medication for at least 4 weeks before enrollment.

Main exclusion criteria: The study excludes those under age 10 or over 17, individuals not taking antipsychotic medications, those with body mass index below the obesity threshold, individuals with known allergies to GLP-1 medications, those with type 1 or 2 diabetes, current or past pancreatitis, severe kidney or liver problems, pregnancy or breastfeeding, and those unable to follow study instructions.

Study focus: The research evaluates how semaglutide affects body weight, body composition including fat and muscle mass, and measures the medication’s impact on appetite and food intake in adolescents whose weight gain is related to antipsychotic treatment.

Investigational drugs: Semaglutide is administered via subcutaneous injection using pre-filled pens at increasing doses from 0.25 mg up to 2.4 mg over the study period, working as a GLP-1 receptor agonist to help control appetite and reduce food intake.

Study of Tirzepatide for Adults with Type 1 Diabetes and Obesity or Overweight

This trial investigates tirzepatide’s effects on blood sugar control in adults with type 1 diabetes who are also dealing with excess weight. The 40-week study evaluates whether weekly injections of this medication can improve glucose management better than placebo.

Main inclusion criteria: Participants must be at least 18 years old, have had type 1 diabetes and been on insulin treatment for at least one year, have blood glucose levels within permitted study limits, and have a body mass index indicating overweight or obesity status.

Main exclusion criteria: Individuals with type 2 diabetes cannot participate, nor can those who are not overweight or do not have obesity.

Study focus: The research examines changes in hemoglobin A1c levels (a measure of average blood sugar over 2-3 months) from the start of treatment to week 40, comparing tirzepatide’s effectiveness against placebo in managing blood glucose in type 1 diabetes patients with weight concerns.

Investigational drugs: Tirzepatide is administered as a once-weekly subcutaneous injection, working by mimicking hormones that help regulate appetite and insulin levels, potentially improving blood sugar control while supporting weight management.

Study of Tirzepatide for Reducing Obesity and Related Health Issues in Adolescents

This research examines whether tirzepatide can help adolescents aged 12-17 reduce their body mass index and improve weight-related health conditions over a 68-week treatment period. The study compares the medication’s effects against placebo.

Main inclusion criteria: Participants must be between 12-17 years old and have a body mass index at or above the 95th percentile for their age and sex according to CDC-NCHS 2022 guidelines.

Main exclusion criteria: The study excludes individuals outside the specified age range, those with medical conditions that could interfere with the study or make participation unsafe, those currently in another clinical trial, individuals who have had recent surgery or are planning surgery during the study period, pregnant or breastfeeding individuals, those with a history of certain medical conditions including heart disease or uncontrolled diabetes, participants unable to comply with study procedures or attend scheduled visits, those with allergies or reactions to the study medication or similar drugs, individuals with a history of substance abuse or alcohol dependency, and those taking medications that could significantly affect body weight.

Study focus: The trial evaluates how effectively tirzepatide reduces body mass index and improves weight-related health issues in adolescent participants, with assessments conducted at 3, 6, 12, and 18 months to monitor progress.

Investigational drugs: Tirzepatide is administered as a weekly subcutaneous injection, belonging to the GLP-1 receptor agonist class of medications that work by mimicking hormones involved in regulating appetite and blood sugar, helping to reduce body weight.

Study on Maintaining Weight Loss in Teens with Obesity Using Semaglutide

This long-term trial studies how semaglutide helps teenagers maintain weight loss after they have successfully reduced their body mass index below the obesity threshold. The study extends up to six years, examining both weight maintenance and dose reduction strategies.

Main inclusion criteria: Participants must be between 12 and less than 15 years old at enrollment, with a body mass index at or above the 95th percentile for their age and sex, weighing more than 60 kilograms, and having agreement from both the participant and their parent or legally acceptable representative.

Main exclusion criteria: Those who have not achieved a body mass index below the obesity threshold after 1.5 years of initial treatment cannot participate, nor can individuals not currently receiving semaglutide treatment, non-adolescents, those unwilling or unable to follow the dose-tapering plan, or individuals with medical conditions or situations that could interfere with the study’s results or the participant’s safety.

Study focus: The research examines whether adolescents can maintain a body mass index below obesity levels during a dose-tapering phase from 1.5 to 3 years, and evaluates long-term health parameters including body composition, blood pressure, and metabolic markers through extended monitoring up to 6 years.

Investigational drugs: Semaglutide is administered as a once-weekly subcutaneous injection in various doses from 0.25 mg to 2.4 mg, working as a GLP-1 receptor agonist to help maintain weight loss by mimicking hormones that regulate appetite and food intake.

Study on Pain Relief After Obesity Surgery Using Esketamine, Dexmedetomidine, and Lidocaine Hydrochloride Monohydrate for Patients Undergoing Obesity Surgery

This trial compares an opioid-sparing pain management approach using alternative medications against traditional opioid-based treatment in patients undergoing laparoscopic weight loss surgery. The study follows participants for up to 24 months to assess pain relief, recovery, and quality of life.

Main inclusion criteria: Participants must be 18 years or older, scheduled for laparoscopic gastric bypass or sleeve surgery, and willing to provide informed consent. Both men and women can participate, but the study does not include vulnerable populations.

Main exclusion criteria: Individuals not undergoing weight loss surgery, those not experiencing postoperative pain, people outside the specified age range, and members of vulnerable populations cannot participate.

Study focus: The research examines whether an opioid-sparing care pathway using medications like esketamine, dexmedetomidine, and lidocaine reduces postoperative nausea, vomiting, and pain while improving recovery compared to conventional opioid-based treatment, with assessments conducted immediately after surgery and at multiple follow-up points over 24 months.

Investigational drugs: The study tests an opioid-sparing approach using alternative pain management strategies and non-opioid medications, comparing it to conventional opioid-based treatment to evaluate effectiveness in managing post-surgical pain while minimizing side effects associated with opioids.

Study on Rimegepant and Capsaicin for Migraine in Lean and Obese Patients

This research investigates how rimegepant affects body responses to certain stimuli in people with different body compositions, specifically comparing lean and obese individuals. The study examines changes in skin blood flow and other body measurements to understand how body weight might influence the medication’s effects.

Main inclusion criteria: Participants must be males or females aged 18-30 years with a body mass index either between 18.5-22 or 30 or higher, in general good health based on self-reported medical history. Female participants must have regular menstrual cycles of 25-35 days or use oral hormonal contraceptives consistently for at least one month.

Main exclusion criteria: The study excludes individuals outside the specified age range, those not considered healthy with other medical conditions, participants unable to follow study procedures or take the study medication as directed, women who are pregnant or breastfeeding, anyone with known allergies to rimegepant, those currently participating in or having recently participated in another clinical trial, people with a history of drug or alcohol abuse, participants with significant medical conditions that could interfere with study results, and individuals with a history of substance abuse or addiction.

Study focus: The trial evaluates how rimegepant influences dermal blood flow before and after taking the medication, measures blood levels of sex steroids and rimegepant concentration, and assesses body composition parameters including total body weight, water content, and fat mass.

Investigational drugs: Rimegepant is taken orally as a 75 mg dose, working by blocking the CGRP receptor protein involved in migraine development, helping to reduce the frequency and severity of migraine attacks.

Study on Semaglutide and Low Energy Diet for Obesity in Adolescents Aged 12-17

This trial combines semaglutide medication with an 8-week low-energy diet program followed by 52 weeks of behavioral therapy to evaluate weight management in adolescents. The study compares this combined approach against lifestyle changes alone to determine the medication’s added benefit.

Main inclusion criteria: Participants must be between 12 and 18 years old with parental consent, be seeking treatment for obesity with a body mass index of 35 or higher (or 30 or higher with at least one weight-related health issue), have tried at least once to lose weight through diet unsuccessfully, and be willing to sign a consent form agreeing to follow the study rules and requirements.

Main exclusion criteria: The study excludes patients not between 12 and 18 years old, those without obesity, individuals unwilling to participate in a 52-week program including behavioral therapy, and those unable to complete an initial 8-week low-energy diet program combining face-to-face and electronic sessions.

Study focus: The research examines whether semaglutide combined with lifestyle intervention is more effective than lifestyle intervention alone in reducing body mass index and improving health markers such as blood glucose, cholesterol, and blood pressure over a 52-week treatment period.

Investigational drugs: Semaglutide is administered as a once-weekly 2.4 mg subcutaneous injection, working as a GLP-1 receptor agonist to help reduce body weight by mimicking a hormone that regulates appetite and food intake.

Study on Semaglutide for Achieving Sinus Rhythm in Patients with Obesity and Persistent Atrial Fibrillation

This one-year trial investigates whether semaglutide can help restore normal heart rhythm in patients with both obesity and persistent atrial fibrillation. The study monitors participants to determine if the medication supports a return to sinus rhythm while also examining effects on weight and other health factors.

Main inclusion criteria: Participants must be 18 years or older with symptomatic, first detected persistent atrial fibrillation (noticed no more than 6 months before joining), a body mass index of 30 or higher (or 27 or higher with at least one weight-related health condition like high blood pressure, high cholesterol, sleep problems, or heart disease), be scheduled for electrical cardioversion, and provide written informed consent.

Main exclusion criteria: Patients without obesity cannot participate, nor can those without atrial fibrillation, individuals who have not experienced symptomatic persistent atrial fibrillation, those not within the specified age range, or members of vulnerable populations.

Study focus: The research examines whether semaglutide helps achieve normal heart rhythm at 12 months while monitoring changes in weight, waist size, blood pressure, cholesterol levels, and tracking adverse events and hospital visits.

Investigational drugs: Semaglutide is administered as a once-weekly 2.4 mg subcutaneous injection, working as a GLP-1 receptor agonist to help regulate appetite and potentially improve heart rhythm by mimicking natural GLP-1 hormone actions.

Summary

The 64 ongoing clinical trials for obesity demonstrate a diverse research landscape spanning multiple countries and patient populations. Denmark, Germany, and Spain appear as the most active locations for obesity research, hosting numerous studies across different medication types and patient groups.

The trials show a clear focus on GLP-1 receptor agonists, with semaglutide and tirzepatide appearing in multiple studies across different populations including children, adolescents, and adults with various comorbidities. Several novel compounds like retatrutide, orforglipron, and maridebart cafraglutide are being investigated in Phase 2 and 3 trials, indicating active development of new treatment options.

Notable patterns include increasing attention to special populations such as adolescents taking antipsychotic medications, patients with inadequate response to bariatric surgery, and individuals with specific comorbidities like atrial fibrillation, sleep apnea, and cardiovascular disease. Many studies combine medication treatment with lifestyle interventions including reduced-calorie diets and increased physical activity.

The research also addresses important clinical questions about treatment duration, dose tapering, weight maintenance after initial loss, and the impact of obesity treatments on conditions beyond weight reduction such as liver fat content, heart function, and blood sugar control. Several trials investigate combination therapies and compare different dosing strategies or formulations.

Ongoing Clinical Trials on Obesity

  • Zenagamtide Compared with Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

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    Bulgaria Croatia Germany Hungary Poland Portugal +1
  • RO7795068 for Weight Loss in Adults With Obesity or Overweight and Type 2 Diabetes

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    Czechia France Germany Hungary Italy Poland +2
  • Efficacy and Safety of MET097 Once Weekly in People with Overweight or Obesity and Type 2 Diabetes

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    Bulgaria Czechia Germany Hungary Poland Romania +2
  • RO7795068 for Weight Loss in Adults With Obesity or Overweight Without Type 2 Diabetes

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    Belgium Czechia France Germany Hungary Italy +3
  • Zenagamtide for Weight Loss in Adults with Obesity

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    1 1
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    Belgium Denmark France Germany
  • A Study of Zenagamtide in Adults With Overweight or Obesity and Type 2 Diabetes

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    Croatia Hungary Italy Romania Slovakia
  • Study of mirikizumab and tirzepatide in adults with moderate to severe ulcerative colitis who are overweight or obese

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    Austria Belgium Bulgaria Czechia Denmark France +9
  • A study of eloralintide in adults with persistent obesity or overweight who are currently treated with a weekly incretin medication

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    Belgium Czechia Romania Spain
  • Study of Zenagamtide (NNC0487-0111) versus placebo in patients with heart failure with preserved or mildly reduced ejection fraction and obesity

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    Bulgaria Czechia Denmark France Germany Greece +4
  • A study to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight and type 2 diabetes

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    Czechia Germany Poland Slovakia Spain