Boehringer Ingelheim’s metabolic disease pipeline has gotten a boost with promising late-stage results for survodutide, the company’s dual GLP-1 and glucagon receptor agonist being developed for obesity and overweight management.
In the Phase III SYNCHRONIZE-1 trial, patients treated with survodutide achieved an average weight loss of up to 16.6% over 76 weeks, compared to 3.2% in the placebo group, with additional reductions in waist circumference and markers of cardiometabolic risk, indicative of meaningful improvements in overall metabolic health.
Participants lost up to an average of 39.2 lb (17.8 kg) from baseline after 76 weeks of treatment with survodutide, meeting both weight loss primary endpoints and its key secondary endpoint evaluating waist circumference.
In comparison, Novo Nordisk’s GLP-1 blockbuster Wegovy (semaglutide) yielded a 12.4% placebo-adjusted weight loss at Week 68 in a Phase III study of a similar patient population.
And Eli Lilly’s Zepbound (tirzepatide), which remains the current frontrunner in the GLP-1 obesity lineup, sits at a 17.8% placebo-adjusted weight loss at Week 72. Eli Lilly is gaining even greater ground in the GLP-1 space with its investigational triple-agonist retatrutide, which has demonstrated even greater efficacy in early data.
The double-blind, placebo-controlled 76-week efficacy and safety trial of survodutide included 725 adults living with obesity or overweight, without type 2 diabetes. Participants received a weekly injection of survodutide at either a 3.6 mg or 6.0 mg dose, or placebo.
Get industry leading pharma and biotech news, events and expert insights delivered to your inbox.
Boehringer Ingelheim is differentiating survodutide with its dual GLP-1 and glucagon receptor agonism. The dual mechanism is designed to enhance fat loss and may offer broader metabolic benefits compared to traditional GLP-1-only therapies, or GLP-1 paired with other receptor agonists.
Specifically, survodutide pairs GLP-1 receptor activation, which reduces appetite and food intake, with glucagon receptor activation, which may further support fat metabolism by increasing energy expenditure.
In comparison, Eli Lilly and Company’s tirzepatide (marketed as Mounjaro for diabetes and Zepbound for obesity) is also a dual agonist, but it targets the glucose-dependent insulinotropic polypeptide (GIP) receptor alongside GLP-1 rather than glucagon. But the company’s new GLP-1 candidate retatrutide offers a “triple threat” mechanism, targeting the GLP-1, GIP and glucagon receptors to drive weight loss through reduced appetite, improved metabolic control and increased energy expenditure.
Survodutide is being developed in collaboration with Zealand Pharma, which retains royalty rights under a long-standing partnership agreement in which Boehringer Ingelheim holds full global responsibility for the development and commercialization of the therapy.
Boehringer plans to present the full Phase III results at the American Diabetes Association’s 2026 Scientific Sessions, with additional studies underway in metabolic dysfunction-associated steatohepatitis (MASH).
Related: Apotex Leads Race for Generic Ozempic with Tentative FDA Approval
While Boehringer reported a statistically significant reduction in waist circumference with survodutide, which is used as a proxy for visceral fat and cardiometabolic risk, it did not share detailed data to support the finding. Visceral fat is closely linked to metabolic dysfunction and impaired liver health, and the results suggest that weight loss was primarily driven by fat rather than lean muscle mass.
Overall, the findings hint at potential advantages for survodutide, but do not yet provide definitive evidence. A clearer understanding is expected as additional data emerge from the SYNCHRONIZE-1 study and the broader Phase III program, including trials in patients with cardiometabolic comorbidities and MASH, as well as cardiovascular, liver and kidney disease outcomes.
Additionally, the latest trial results do not fully clarify questions around the tolerability of survodutide. Those concerns were raised after a Phase II study in which 24.6% of patients discontinued treatment. According to reporting by Fierce Pharma, at a Barclays event last month, Zealand Pharma’s CEO suggested that more flexible dose titration and the use of antiemetic therapies could help better manage side effects in the Phase III program.
In its press release, Boehringer noted that, as is “typical with GLP-1-based therapies,” participants experienced gastrointestinal side effects, and that discontinuations occurred more frequently during the dose-escalation phase. The events were generally mild to moderate, transient and consistent with the known safety profile of the GLP-1 class, with no new safety signals observed, the company said.
Join or login to leave a comment
JOIN LOGIN