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Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity

Main objective:To explore the impact of setmelanotide on obesity in patients with various specific rare genetic mutations.Secondary objective:To assess the effects of setmelanotide on:* Safety and tolerability-Hunger* Waist circumferenceOptional sub…

The effect of the Happi Liver mobile health application on the reduction of non-alcoholic fatty liver disease

The purpose of this study is to determine the effect of using the Happi Liver application on the course of the liver disease non-alcoholic fatty liver disease (NAFLD).

The impact of a preoperative very low calorie ketogenic diet (VLCKD) on body composition in patients undergoing bariatric surgery: an open trial

The main objective of the proposed study is to investigate the effect of a VLCKD on body composition in patients undergoing bariatric surgery, and to compare this with a standard VLCD.

Preoperative predictors of weight loss and improved metabolic health after bariatric surgery

Primary ObjectiveTo validate biomarkers of response to bariatric surgery and to develop algorithms, which combine these variables, to predict individual responses. Secondary Objectives* To establish the predictive value of selected preoperative…

Open-label, randomised, 4 parallel-group, Phase I clinical trial to investigate BI 456906 occupancy of Glucagon receptors in liver and Glucagon-like Peptide 1 receptors in pancreas in comparison with semaglutide after administration of radiolabeled tracer in male and female subjects with obesity using PET and MRI

This study has been transitioned to CTIS with ID 2024-515417-17-00 check the CTIS register for the current data. The main objective of this trial is to investigate glucagon receptor occupancy of BI 456906 in the liver with PET imaging using the…

Long Term Extension Trial of setmelanotide (RM-493) for patients who have
completed a trial of Setmelanotide for the treatment of obesity associated with
genetic defects upstream of the MC4 receptor in the leptin-melanocortin
pathway

To characterize safety and tolerability of setmelanotide in patients who have completed treatment in a previous trial of setmelanotide for obesityassociated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway and…

Applying Mysimba in patients with weight regain after bariatric surgery

This study has been transitioned to CTIS with ID 2024-516645-39-01 check the CTIS register for the current data. The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss(&…

Assessment of Mass Balance of Orally Administered [14C] Tagatose in Healthy Volunteers Using a Microtracer Approach

To determine the mass balans after ingestion of a single dose of tagatose, a low-glycaemic sugar, in healthy volunteers.

The effect of lidocaine infusion on ad libitum food intake and satiety in healthy volunteers

We hypothesize that intragastric infusion of lidocaine will result in a delay of postprandial satiation and hereby an increase in food intake at an ad libitum meal. Furthermore, we hypothesize that lidocaine infusion will not result in an increase…

GASTROESOPAHGEAL REFLUX DISEASE AFTER N-SLEEVE VERSUS ROUX-EN-Y GASTRIC BYPASS (GINSBY): A RANDOMISED CONTROLLED TRIAL

The aim of this study is to determine the effectiveness of N-sleeve in terms of a reduction of GERD in morbidly obese patients, compared to LRYGB.

A Phase II, randomized, double blind, parallel group,46 weeks dose-finding study of BI 456906 administered once weekly subcutaneously compared with placebo in patients with obesity or overweight

The overall purpose of this trial is to assess the efficacy on weight loss and maintenance, and tolerability of four different doses of BI 456906 compared to placebo in patients with obesity or overweight (BMI >= 27kg/m2), without type 1 or…

The effect of quinine on food intake: oral sham feeding versus intragastric delivery

To investigate the effect of oral sham feeding of and intragastric delivery of quinine (a bitter agent) versus placebo on food intake.

ENDURE II: AN INVESTIGATIVE, PROSPECTIVE, NON-RANDOMIZED, MULTI-CENTER STUDY TO ASSESS THE SAFETY AND EFFECTIVENESS OF A NOVEL GASTRIC RESTRICTIVE DEVICE, CALLED THE RESHAPE VEST*, IN PEOPLE WHO ARE OBESE.

To assess the safety and effectiveness of the LGV in treating obese subjects with a BMI of 35 kg/m2 to 55 kg/m2 who have failed one or more conservative weight-reduction alternative(s), such as supervised diet, exercise, and behavior modification…

SUGAR Trial: Influence of adding a subtotal gastrectomy to laparoscopic gastric bypass surgery on striatal D2/D3 receptor availability. A Single blinded, randomized, single center study.

Primary Objective: To evaluate the effects of LRYGB with subtotal gastrectomy (LRYGB+) as compared to standard LRYGB (LRYGB-) on striatal D2/D3 receptor availability and dopamine release as well as on whole brain serotonergic activity. Secondary…

A randomized controlled trial on the effect of pre-thickened oral nutritional supplements on nutritional status of nursing home residents with oropharyngeal dysphagia and (at risk of) malnutrition

The aim of this study is to determine whether the daily use of thickened oral nutritional supplements has an effect on the weight of nursing home residents with dysphagia and (risk for) malnutrition.

Single center, prospective,single-arm feasibility study to evaluate the safety ofthe PlenSat Digestible Balloons in thetreatmentofObesity

The objective of this study is to evaluate the safety of the PlenSat Digestible Balloons.

An Open Label, 1-Year Trial, including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset Leptin Receptor (LEPR) Deficiency Obesity due to Bi-Allelic Loss-of-Function LEPR Genetic mutations

The main purpose of this trial is to find out if an investigational drug called setmelanotide (RM-493), which mimics MSH, can help control body weight. The efficacy of setmelanotide will be compared to the efficacy of a placebo during 4 to 8 weeks.

Determinants of weight loss after bariatric surgery

To evaluate phenotypic, genetic, behavioural and environmental characteristics of patients after bariatric surgery and find predictors of response to bariatric surgery. In addition, to compare changes in cardiorespiratory fitness, fat free mass and…

Single center, prospective, single-arm feasibility study to evaluate the safety of the PlenSat Digestible Balloons in the treatment of Obesity

The objective of this study is to evaluate the safety of the PlenSat Digestible Balloons.

Effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.
A randomised, placebo controlled, parallel group, multi-centre, multinational trial with a 16-week double-blind period and 36-week open-label period.

Primary objective- To compare the efficacy of liraglutide versus placebo on weight loss in obese paediatric subjects with PWS at 16 weeks and versus no treatment at 52 weeks.Secondary objectives - To compare the efficacy of liraglutide versus…