Vall d’Hebron has participated in an international phase 2 clinical trial, called SOLSTICE, which evaluated the efficacy and safety of elecoglipron for the treatment of type 2 diabetes. The study, published in The Lancet, included the participation of Dr. Andreea Ciudin, coordinator of the Comprehensive Obesity Treatment Unit at Vall d’Hebron University Hospital and principal investigator of the Diabetes and Metabolism research group at the Vall d’Hebron Research Institute (VHIR).
The trial involved 404 people with type 2 diabetes, divided into different groups: one receiving elecoglipron at various doses (between 5 mg and 75 mg) once daily, another receiving placebo, and a third treated with semaglutide for comparison purposes. Semaglutide is one of the drugs commonly used for the treatment of type 2 diabetes and obesity. Patients were followed for 26 weeks.
The main objective of the study was to analyze the reduction in glycated hemoglobin (HbA1c), a blood marker that reflects the average blood sugar levels over the previous three months. At week 26, the results showed that patients treated with elecoglipron improved their blood glucose levels, with HbA1c reductions ranging from 0.9% to 1.9% depending on the dose. In contrast, patients who received placebo showed an increase of 0.2%. In the semaglutide group, the reduction was 1.3%.
Improvements in body weight were also observed. Patients treated with elecoglipron experienced weight reductions ranging from 2.9% to 7.7%, compared with 1.7% in the placebo group. With semaglutide, the reduction was 5.1%.
The most frequent adverse events were related to gastrointestinal disorders, such as nausea, constipation, diarrhea, or vomiting. In general, these effects were not severe and occurred mainly in individuals who had received higher doses.
“The results show that elecoglipron is effective and safe compared with placebo, with a profile similar to that of semaglutide, positioning it as a potential new therapeutic alternative”, explains Dr. Ciudin. “Initiating these treatments early is key to controlling associated cardiovascular and renal risks and improving long-term disease progression”, she adds.
To confirm these findings and continue the clinical development of elecoglipron, the phase III clinical trial called EMBOLD has recently begun, with Dr. Ciudin serving as principal investigator.
A new oral drug with fewer restrictions than semaglutide
Like other drugs already approved for obesity, elecoglipron acts on the GLP-1 receptor, which is involved in the regulation of appetite and metabolism in the brain and digestive tract. Several studies have demonstrated the effectiveness of this type of drug in controlling glycemia and body weight.
Unlike other drugs targeting this receptor, such as semaglutide, elecoglipron is a non-peptide molecule. This allows for oral administration with fewer restrictions; for example, it does not need to be taken on an empty stomach or followed by a 30-minute waiting period before eating.
Vall d’Hebron actively participates in clinical trials involving different drugs that provide new options for patients. For example, it took part in the phase 3 clinical trial that recently led to the approval by the U.S. Food and Drug Administration (FDA) of another obesity drug with similar characteristics: orforglipron. “Vall d'Hebron is at the forefront of testing new therapies to improve the lives of patients with obesity and type 2 diabetes”, concludes Dr. Ciudin.
Image: Dra Andreea Ciudin
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