Boehringer Ingelheim has revealed its strategic plan to propel survodutide, a dual agonist for the glucagon/GLP-1 receptor, into three distinct Phase III global studies aimed at individuals grappling with overweight or obesity. This decision comes on the heels of the recent unveiling of Phase II trial results, which showcased remarkable outcomes in individuals with overweight or obesity, demonstrating weight loss rates of up to 19 percent after undergoing a 46-week treatment regimen involving survodutide.
Survodutide activates the GLP-1 and glucagon receptors, which play pivotal roles in regulating metabolic functions. The intricacies of these Phase III trials will be disclosed before their initiation, and patient enrollment is slated for completion by the close of 2023.
It's noteworthy that survodutide has been assessed in a Phase II study involving adults afflicted with NASH and liver fibrosis (in stages F1/F2/F3), with or without type 2 diabetes, and has garnered US FDA Fast Track Designation for this application. Conceived collaboratively by Boehringer Ingelheim and Zealand Pharma, survodutide constitutes an integral component of Boehringer Ingelheim's research and development endeavours, with a particular focus on the realms of cardio-renal-metabolic diseases.
Novo Nordisk has unveiled the headline findings of the SELECT cardiovascular outcomes trial, disclosing that Wegovy (semaglutide 2.4 mg) demonstrates a significant 20% reduction in major adverse cardiovascular events (MACE) for adults with overweight or obesity.
The double-blind trial, spanning up to five years, juxtaposed subcutaneous weekly doses of semaglutide 2.4 mg against a placebo to augment standard care for MACE prevention in individuals aged 45 years or older. The trial's enrollment included 17,604 adults with established cardiovascular disease (CVD) who had overweight or obesity but no prior diabetes history.
The trial effectively met its primary goal of showcasing a statistically noteworthy and superior 20% decrease in MACE for those administered Wegovy 2.4 mg versus the placebo. The study's primary endpoint was framed as a composite outcome, encompassing the initial occurrence of MACE, defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. All three elements of the primary endpoint contributed to the observed MACE reduction associated with Wegovy 2.4 mg, with 1,270 first MACE events recorded.
Throughout the trial, Wegovy 2.4 mg exhibited a profile of safety and tolerability that aligned with previous trials involving the same dosage.
Wegovy (once-weekly subcutaneous semaglutide 2.4 mg) emerges as a GLP-1 receptor agonist that garners indication as an adjunct to a calorie-restricted diet and heightened physical activity. It manages chronic weight issues in adults with a BMI of 30 kg/m2 or greater (obesity) and those with a BMI of 27 kg/m2 or greater (overweight) alongside at least one weight-related comorbidity. Wegovy is currently available in the U.S., Denmark, Norway, and Germany.
In the Phase 3 trial SURMOUNT-1, Lilly's tirzepatide reduced the weight at week 72 compared to placebo, and participants lost weight up to 24 kg. The trial enrolled 2,539 participants and was intended to evaluate the efficacy of tirzepatide in adults with obesity or overweight and with one co-morbidity without diabetes.
The primary endpoints of the clinical trial were percentage change from baseline in body weight and participants achieving ≥5% bodyweight reduction.
The company announced that its safety profile is in-line with other incretin-based therapies approved for obesity.