Survodutide

A little known South Korean biotech said Monday that its experimental treatment yielded encouraging results in the race to treat metabolic dysfunction-associated steatohepatitis (MASH). D&D Pharmatech reported that DD01 hit the main goal of a Phase II trial — and investors took notice, sending the company's stock soaring to the 30% daily limit on Korea's KOSDAQ exchange.The once-weekly dual GLP-1/glucagon receptor agonist was evaluated in 67 overweight or obese individuals with MASH. Treatment began with a two-week lead-in 20-mg subcutaneous dose, followed by a maintenance dose of 40 mg administered once weekly.After 12 weeks, results showed that 75.8% of patients on DD01 had at least a 30% drop in liver fat, compared to 11.8% of those on placebo. The drug was associated with a 62.3% relative reduction in liver fat compared to 8.3% with placebo.Additionally, 72.7% of subjects had their liver fat reduced by half, compared to 5.9% for placebo; and 48.5% reached normalisation — defined as 5% or less — while no one in the placebo group reached that mark.Beyond liver fat reduction, DD01 also significantly improved liver stiffness and other non-invasive markers of disease, as well as body weight and HbA1c, although the study population was not selected to be diabetic.CEO Seulki Lee called the results "remarkably positive," and said that "the magnitude of improvements is equivalent to what has been achieved only after longer-term treatment with FGF and GLP-1 based drugs already validated with histology data in MASH."The treatment was generally well tolerated, though as with other GLP-1-based therapies, gastrointestinal (GI) side effects were most common. Three participants dropped out due to GI issues, but the company described events as "generally mild to moderate, but transient and manageable."Several companies have been vying for a piece of the MASH pie. Novo Nordisk's semaglutide, branded as Ozempic for diabetes and Wegovy for weight loss, recently succeeded in the Phase III ESSENCE trial, earning a priority review from US regulators for MASH.Eli Lilly's competing drug tirzepatide, sold as Mounjaro/Zepbound, also hit met the primary endpoint of the Phase II SYNERGY-NASH trial, while Boehringer Ingelheim's Zealand Pharma-partnered survodutide has shown promising mid-stage results. For a detailed overview, see – Vital Signs: Tracking the MASH queue for GLP-1 agonists.

Metabolic dysfunction-associated steatohepatitis is a chronic liver condition. Credit: Antonio Marca/Shutterstock. Echosens and Boehringer Ingelheim have expanded their collaboration aimed at expediting progress in metabolic dysfunction-associated steatohepatitis (MASH) diagnosis and care. The joint effort seeks to address the critical need for early screening and diagnosis as MASH becomes a leading cause of liver failure globally. The combination of Echosens and Boehringer Ingelheim’s diagnostic and therapeutic capabilities is set to bridge gaps in awareness, evidence and clinical practice. Their combined initiatives will emphasise patient education, healthcare professional engagement, policy advocacy, streamlined care pathways adoption and broaden access to non-invasive technologies. MASH is a chronic liver condition linked with obesity that can progress silently to a severe stage without intervention. Boehringer Ingelheim head of the therapeutic area for cardiovascular, renal and metabolic Sandy Sommer stated: “For too long, serious liver diseases like MASH have gone under the radar — but with MASH rates soaring alongside the global obesity epidemic, it’s time to tackle liver disease head on. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Obesity and MASH are deeply interconnected chronic diseases that no organisation can tackle alone. At Boehringer, we’re committed to being part of the solution, and the expansion of our partnership with Echosens is one we’re particularly excited about.” Echosens’ FibroScan, a non-invasive liver assessment technology, has been instrumental in supporting Boehringer Ingelheim’s Survodutide Phase III trials by facilitating patient screening and monitoring. Survodutide combines glucagon-like peptide-1 (GLP-1) with glucagon receptor agonists for MASH and related metabolic disorders such as obesity. Boehringer Ingelheim holds global responsibility for the development and commercialisation of Survodutide after licensing it from Zealand Pharma. It forms part of the company’s broader research and development efforts focusing on cardiovascular, renal and metabolic diseases. In May 2025, Boehringer partnered Tempus AI to develop a cancer therapy pipeline. Pharmaceutical Technology Excellence Awards - Have you nominated? Nominations are now open for the prestigious Pharmaceutical Technology Excellence Awards - one of the industry's most recognised programmes celebrating innovation, leadership, and impact . This is your chance to showcase your achievements, highlight industry advancements , and gain global recognition . Don't miss the opportunity to be honoured among the best - submit your nomination today! Nominate Now