Clinical Trials

The purpose of this trial is to evaluate the proportion of obese patients who respond to setmelanotide at 52 weeks of treatment. The trial includes multiple independent sub-studies of setmelanotide in patients with obesity and at least one of 6 specific gene defects in the Melanocortin-4 Receptor pathway. 

The purpose of this trial is to evaluate the effect of treatment with BI 456906 3.6 and 6.0 mg once weekly versus (vs.) placebo on cardiovascular (CV) safety as an adjunct to standard of care for CV risk reduction, a reduced-calorie diet, and increased physical activity in trial participants with body mass index (BMI) ≥27 kg/m^2 with either established cardiovascular disease (CVD) or chronic kidney disease (CKD), and/or at least 2 weight-related complications or risk factors for CVD.

The purpose of this study is to evaluate the effect of IC-CBAS 1000 mg BID on EEC function, weight loss, satiety perception, and satiety GI hormones, in patients with APS-OB phenotype. A lifestyle intervention will be provided. These consist of an obesity physician consult, a low-calorie diet instructed by registered dietitians & nutritionists, and physical activity and behavioral suggestions. These interventions should last at least the length of the study. We will include otherwise healthy patients with a BMI > 30, age range 18-65 years, and APS-OB phenotype. Based on the results of our previous trial comparing weight loss in exenatide therapy vs placebo (Acosta, Camilleri, and Burton 2015), we calculated a sample size of 18 participants per group (total of 36) with 80% power, 0.05 alpha to detect a 1 kg difference between treatment and placebo groups. 

To evaluate the proportion of obese patients with genetic defects in the melanocortin-4 receptor (MC4R) pathway who achieve a clinically meaningful reduction in body weight in response to setmelanotide after an initial response to open-label treatment

The purpose of this extension study of up to an additional 2 years duration beyond the index trial for patients who have completed a previous study of setmelanotide for genetic obesity disorders upstream of the MC4 receptor in the melanocortin-leptin pathway. Since continued assessments of the safety and efficacy of setmelanotide are the same in this extension protocol regardless of the disease studied in the index protocol, all patients can be followed in this single extension protocol. Nevertheless, the analysis of each individual disease will be performed separately with the ability to combine data from the original index protocol and this extension protocol on a disease specific basis. For patients who qualify and consent, the study will start immediately on the completion of their index protocol such that there are no gaps in setmelanotide therapy , if possible. Efforts should be made to allow the last visit of a prior index trial or an index trial extension phase and the initial visit of this comprehensive long-term extension trial to occur on the same day. Patients will continue taking the same dose of setmelanotide that they were taking when they finished the index protocol. Dose changes can be made for safety or efficacy. Patients will be assessed in the clinic approximately every 3 months for vital signs, adverse events, concomitant medications, weight, waist circumference, and hunger score. Safety laboratories will be collected at each visit and additional assessments will be done on a yearly basis. In general assessments will be less frequent and burdensome than was required in their index protocol.

It is unknown whether the bile acid pathway is altered in obesity. This study is designed to compare obesity and health to determine if the bile acid pathway differs depending on health state.

To study the effect of an ileocolonic formulation of ox bile extract on insulin sensitivity, postprandial glycemia and incretin levels, gastric emptying, body weight and fasting serum FGF-19 (fibroblast growth factor) levels in overweight or obese type 2 diabetic subjects on therapy with DPP4 (dipeptidyl peptidase-4) inhibitors (e.g. sitagliptin) alone or in combination with metformin.

The purpose of this study is to explore the impact of Setmelanotide on obesity in patients with various specific rare genetic mutations.

The purpose of this study is to define an "individualized diet" approach based on obesity related phenotypes (pathophysiology obesity classification), which would increase weight loss, adherence, and weight loss maintenance.

The researchers are trying to identify the specific characteristics (phenotypes) that may be useful to help select the right medication for weight loss.