Boehringer Ingelheim's glucagon/GLP-1 dual agonist obesity shot survodutide helped patients lose up to 16.6% of their body weight after nearly 17 months in a phase 3 study, the German drugmaker said today.
While the results fall short of the weight loss standard set by Eli Lilly's Zepbound, Boehringer's drug, which was licensed from Zealand Pharma, compares more closely to Novo Nordisk's Wegovy shot.
However, survodutide may be better at maintaining lean muscle mass, cutting cardiometabolic risk, and supporting liver function than the two options already on the market, Boehringer suggests.
The announcement comes as concerns from healthcare professionals grow about the health impacts of long-term GLP-1 use, especially muscle mass loss and nutritional deficiencies.
In the Synchronize-1 trial, 725 adults with obesity or overweight were randomized to the placebo arm or one of two different weekly dosing groups. After 72 weeks, those taking survodutide lost up to an average of 13.4% of their body weight after adjusting for placebo, according to the press release.
In a comparable patient population, Wegovy triggered a 12.4% placebo-adjusted weight loss after 68 weeks, while dual agonist Zepbound led to a 17.8% placebo-adjusted weight loss at 72 weeks in late-stage studies.
But early analysis indicates that most of the weight people lost while taking survodutide came from fat loss, with "only a small proportion" coming from lean mass, Boehringer said. These findings differ from those of other GLP-1 drugs on the market, as research shows that almost 40% of the weight lost on GLP-1 drugs can come from lean muscle.
Boehringer also reported a statistically significant drop in waist circumference -- a clinical marker linked to visceral fat and cardiometabolic risk. Visceral fat, especially around the stomach, is a known contributor to metabolic dysfunction and is closely connected to impaired liver function.
The Big Pharma company also said its dual agonist has the potential to address obesity while supporting liver function, which is a key regulator of metabolic health, but it didn't provide data to back these claims.
"Today's Synchronize-1 topline results strengthen our confidence in survodutide as a treatment candidate capable of addressing obesity and potentially offering targeted weight loss to help address connected conditions, including liver disease," Shashank Deshpande, chairman of the board of managing directors and head of human pharma at Boehringer Ingelheim, said in a press statement.
In terms of tolerability, adverse health reactions, including gastrointestinal issues, from survodutide were similar to those associated with other GLP-1 receptor agonists. Boehringer said these temporary side effects were mild to moderate in severity, with no new safety signals observed, though it did not supply supporting data.
However, additional trial results are expected to be read out later this year, the company said.
Survodutide is the first in Boehringer's broader pipeline of metabolic therapies. The company is exploring multiple pharmaceutical approaches to weight management, including a "potential first-in-class" triple GLP-1/GIP/NPY2 receptor agonist peptide therapy and oral treatments, the pharma giant said.
Through its 2011 licensing deal with Zealand, Boehringer gained the global rights to develop and commercialize survodutide, while Zealand retains co-promotion rights in the Nordic countries. The Danish biotech stands to receive up to $340 million in remaining milestone payments from Boehringer, plus royalties on drug sales ranging from the high single digits to the low double digits, if its drug is approved.
Survodutide is also being evaluated in phase 2 trials under the Liverage program for metabolic dysfunction-associated steatohepatitis, more commonly known as MASH, and fibrosis. The FDA awarded survodutide fast-track designation in May 2021 and breakthrough therapy designation in September 2024.
Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.
