- In the SYNCHRONIZE-2 trial, which met its co-primary endpoints, participants achieved significant body weight reduction of up to 13.1% versus 3.1% in the placebo arm, after 76 weeks of treatment with survodutide in people with type 2 diabetes, a population in which weight loss is typically more challenging.1
- Detailed results from the Phase III trial indicate survodutide improves key markers of cardiometabolic health, including a reduction of up to 1.21% in HbA1c from a baseline of 7.4%, alongside improvements in waist circumference and insulin sensitivity, building on evidence of its potential to address the underlying metabolic drivers of obesity and type 2 diabetes.1
asserted
survodutide → meet → obesity
These results were presented today at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) and simultaneously published in The New England Journal of Medicine, with new findings from a body composition sub study of SYNCHRONIZE-1 also being presented.1,2,3
Ingelheim, Germany - Boehringer Ingelheim today announced positive results from the Phase III SYNCHRONIZE-2 trial, which investigates the glucagon/GLP-1 receptor dual agonist survodutide (BI 456906) in adults living with obesity or overweight and type 2 diabetes (T2D).1
asserted
which → present → obesity
The trial met its co-primary endpoints, which were % change in body weight from baseline and body weight reduction of ≥5% from baseline, using both the treatment-regimen* and efficacy estimands†.1
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which → meet → baseline
After 76 weeks of treatment with survodutide, sustained weight loss of up to an average of 13.1% was seen using the efficacy estimand, a statistically significant decrease versus 3.1% in the placebo arm (p<0.0001)‡.1
asserted
loss → sustain → arm
The trial also met its other co-primary endpoint, with up to 79.3% of adults treated with survodutide achieving a body weight reduction of ≥5%, using the efficacy estimand, versus 32.7% in the placebo arm (p<0.0001).1
asserted
% → meet → arm
Full SYNCHRONIZE-2 results were presented today at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) and simultaneously published in The New England Journal of Medicine.1,2
asserted
results → present → Journal
Beyond weight loss, key secondary endpoint results showed that adults treated with survodutide experienced improvements in important cardiometabolic health markers.
asserted
adults → show → markers
This included a significant improvement in blood sugar control, with participants experiencing a reduction of up to 1.21% in HbA1c using the efficacy estimand, compared with a 0.03% reduction in the placebo arm (p<0.0001) from 7.4% HbA1c at baseline.1
asserted
participants → include → baseline.1
Additionally, those receiving survodutide showed significant reductions in waist circumference – a clinical marker closely linked to visceral fat and cardiometabolic risk, of 11.1 cm using the efficacy estimand versus a reduction of 3.5 cm in the placebo arm (p<0.0001).1,4
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those → receive → arm
Insulin sensitivity was also seen to improve, evidenced by reduction in fasting glucose and favorable changes in insulin resistance (HOMA-IR) and insulin secretion (HOMA-β) versus placebo.
asserted
sensitivity → see → placebo
More people on survodutide reverted to normoglycemia (HbA1c<5.7%) during their treatment period than on placebo (up to 29.5% vs 4.0% on placebo, efficacy estimand).1
asserted
people → revert → placebo
Together, these findings demonstrate the potential of glucagon/GLP-1 dual agonism to improve metabolic health, including glycemic control, in people living with obesity and T2D.1
“Obesity and type 2 diabetes are deeply intertwined, with excess weight increasing the risk of T2D.
asserted
weight → demonstrate → T2D.
For people living with these conditions, sustained weight loss is often a biological struggle rather than a lack of willpower,” said Dr. Sean Wharton, M.D., PharmD, Coordinating Investigator of the SYNCHRONIZE-2 trial.
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Wharton → live → trial
“These results are encouraging because, in obesity medicine, clinicians increasingly recognize the opportunity to address multiple interconnected health conditions together.
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clinicians → recognize → conditions
Seeing improvements in glycemic control and insulin sensitivity alongside weight loss provides evidence that tackling obesity can positively influence broader metabolic health.
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tackling → see → health
This brings new optimism to people seeking more effective ways to improve their overall health.”
asserted
This → bring → health
T2D and obesity are interrelated metabolic conditions, with the liver playing a central role in disease progression.5,6
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liver → play → role
Survodutide, an investigational glucagon/ GLP-1 receptor (GCGR) dual agonist, is designed to target multiple underlying metabolic drivers by improving glycemic control, reducing appetite, and supporting reductions in liver fat.7,8,9
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Survodutide → design → reductions
Notably, while glucagon is traditionally associated with raising blood glucose, survodutide’s dual mechanism may help improve insulin sensitivity and glucose management through its effects on liver fat reduction.7,10
uncertain
mechanism → associate → effects
This novel approach challenges conventional understanding of glucagon biology, suggesting that the specific balance of GCGR and GLP-1R agonism may help preserve glycemic control.
uncertain
balance → challenge → control
Survodutide has not been approved for use, and its efficacy and safety have not been established.
asserted
efficacy → approve → use
“The growing body of evidence from our SYNCHRONIZE Phase III program continues to strengthen our understanding of survodutide’s potential in people living with obesity, including those with type 2 diabetes.
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body → grow → diabetes
The SYNCHRONIZE-2 results demonstrate meaningful weight loss alongside improvements in glycemic control and other key markers of metabolic health, reinforcing our belief that obesity should be addressed as a complex chronic disease with interconnected health consequences,” said Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma, Boehringer Ingelheim.
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Deshpande → demonstrate → Pharma
“We remain committed to advancing innovative treatment approaches that address the diverse needs of people living with obesity across different stages of disease and risk profiles.
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that → remain → profiles
As expected with GLP-1 based therapies and in line with previously reported survodutide trials, in SYNCHRONIZE-2 the most commonly reported adverse events for survodutide were gastrointestinal (GI) events, which were mostly mild to moderate in severity.1
asserted
which → expect → survodutide
The more frequent events included nausea, vomiting, diarrhea, and constipation.1
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events → include → nausea
The treatment discontinuation rates due to GI adverse events were 18% in people treated with survodutide compared to 1.2% in the placebo arm.1
Discontinuations usually occurred during the dose escalation phase, as the study protocol allowed limited flexibility to manage adverse events.1
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protocol → treat → flexibility
Current and upcoming trials allow for more flexible, patient‑centered titration strategies to support tolerability.11,12
Additional analyses from a sub study in the SYNCHRONIZE-1 trial in people living with obesity without T2D (n=75) were presented alongside the SYNCHRONIZE-2 results.3
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analyses → allow → SYNCHRONIZE-2
MRI-based body composition assessments further reinforced the fat-targeting profile of survodutide, demonstrating preferential reductions in metabolically active visceral and liver fat.3
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assessments → base → reductions
The overall pattern of body composition change suggests a favorable shift away from excessive accumulation of fat around the abdomen.3 Building on previously reported lean mass findings,13 a new muscle-specific analysis showed that muscle accounted for no more than 10% of total tissue lost.3
uncertain
muscle → suggest → tissue
Importantly, reductions in visceral and liver fat appear largely independent of the degree of weight reduction achieved, suggesting that these benefits may extend beyond weight reduction alone.3
Together, the SYNCHRONIZE findings suggest survodutide may help address multiple dimensions of metabolic dysfunction, delivering weight loss and glycemic improvements while reducing harmful visceral and liver fat.
uncertain
survodutide → appear → fat
Furthermore, adipose tissue reduction was shown to be greater than the loss of lean body mass, indicating that the majority of body weight reduction was attributable to the loss of adipose tissue.13
Boehringer Ingelheim has a broad survodutide development program, which spans obesity and related metabolic conditions, MASH and T2D.11,12,14,15,16,17,18,19,20
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which → show → obesity
Boehringer Ingelheim expects to present results from its cardiovascular outcomes trial (SYNCHRONIZE-CVOT) later this year, which will further elucidate survodutide’s cardiovascular safety profile and strengthen understanding of its role within the broader cardiometabolic disease continuum.17
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which → expect → continuum.17
Additionally, Boehringer launched the Phase III SYNCHRONIZE-T2D (NCT07754461) trial to further investigate the effect of survodutide on improving glycemic control in adults with T2D who are managing their condition with diet and exercise alone or in combination with diabetes medications, including insulin.20
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who → launch → insulin.20
* The treatment-regimen estimand is the estimated treatment effect, regardless of whether the patient adheres to the treatment, discontinues, or initiates other therapies.
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patient → estimate → therapies
†The efficacy estimand is the estimated treatment effect assuming patients remained on treatment for the entire study duration.
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patients → estimate → duration
Notes to editors
About obesity and overweight
More than one billion people around the world are living with obesity today (1 in 8 of us) - and by 2030, that number could be more than double what it was in 2010.21
uncertain
it → live → 2030
Overweight and obesity are complex chronic conditions involving abnormal or excessive fat accumulation that present a risk to a person’s overall health.22
About survodutide (BI 456906)
Survodutide is a glucagon/GLP-1 receptor dual agonist that activates both the glucagon and GLP-1 receptors, which play a role in controlling metabolic functions.7,9,23
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which → involve → role
Survodutide is an investigational agent and has not been approved for use; its efficacy and safety has not been established.
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efficacy → approve → use
It is being evaluated in a robust Phase III clinical development program, including the SYNCHRONIZE studies for people living with overweight or obesity,14,15,16,17,18,19 the LIVERAGE studies for people living with MASH and fibrosis,11,12 and SYNCHRONIZE T2D for adults with T2D.20
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It → evaluate → T2D.20
…and 26 more, not listed.
The Aporia
