Survodutide (BI 456906) is Boehringer Ingelheim's investigational dual glucagon/GLP-1 receptor agonist, developed in partnership with Zealand Pharma. Unlike single-target GLP-1 medications, survodutide's added glucagon receptor activity is intended to increase energy expenditure and directly target liver fat metabolism, alongside the appetite-suppressing GLP-1 effect. It is not approved for any indication. Two Phase 3 readouts in 2026 are relevant to its NASH/MASH-adjacent development program.
SYNCHRONIZE-1: the obesity program's headline trial
Topline results from SYNCHRONIZE-1 were announced April 28, 2026, with full data presented at the American Diabetes Association's 2026 Scientific Sessions and published simultaneously in the New England Journal of Medicine.[1] The 76-week trial enrolled adults with obesity or overweight without type 2 diabetes.
The trial met both co-primary endpoints (using the efficacy and treatment-regimen estimands) as well as a key secondary endpoint on waist circumference. A pre-specified body composition analysis reported a 34% reduction in visceral fat and roughly 63–64% reduction in liver fat, with survodutide's glucagon receptor component specifically credited for minimizing lean mass loss relative to what's typically seen with GLP-1-only agents at comparable weight loss.[2]
How survodutide's weight loss compares
At 16.6%, SYNCHRONIZE-1's headline figure sits ahead of semaglutide 2.4mg (14.9% in STEP-1) but behind tirzepatide (20.9% in SURMOUNT-1), higher-dose semaglutide 7.2mg (20.7% in STEP UP), and Novo Nordisk's cagrilintide/semaglutide combination CagriSema (20.4% in REDEFINE-1). These are cross-trial comparisons, not head-to-head data — different trial populations and designs limit how directly the percentages can be compared.
SYNCHRONIZE-MASLD: the liver disease data
SYNCHRONIZE-MASLD, published in Nature Medicine on June 8, 2026, was a randomized, double-blind, placebo-controlled Phase 3 trial in 218 adults with obesity and metabolic dysfunction-associated steatotic liver disease (MASLD) with evidence of inflammation and/or fibrosis.[3] The trial met both of its primary endpoints. Relative to baseline, liver fat normalization was reached by 6 of 10 participants treated with survodutide after 48 weeks.[4]
Liver fat normalization was reached by 6 out of 10 participants living with MASLD and obesity or overweight who were treated with survodutide after 48 weeks.
Where this fits relative to dedicated MASH/fibrosis trials
It's worth being precise about trial scope here: SYNCHRONIZE-MASLD studied MASLD generally, with evidence of inflammation or fibrosis — not the specific histologically-confirmed MASH-with-fibrosis population that the dedicated LIVERAGE and LIVERAGE-Cirrhosis Phase 3 programs target. Those two trials, launched following FDA Breakthrough Therapy designation based on Phase 2 data, are longer-duration outcome studies: LIVERAGE is designed to assess MASH/fibrosis improvement at 52 weeks and hard clinical outcomes (progression to end-stage liver disease) over approximately seven years in patients with moderate-to-advanced fibrosis; LIVERAGE-Cirrhosis targets patients who already have MASH-related cirrhosis.[5] Neither LIVERAGE trial has reported Phase 3 results as of this writing.
SYNCHRONIZE-MASLD is not the same trial as the dedicated MASH-fibrosis outcome studies. Coverage that describes survodutide as having "Phase 3 MASH results" should be checked against which specific trial — SYNCHRONIZE-MASLD (broader MASLD population, reported) versus LIVERAGE/LIVERAGE-Cirrhosis (MASH-specific fibrosis/cirrhosis outcomes, still ongoing) — is actually being cited.
Survodutide remains investigational. Its efficacy and safety have not been established by regulatory approval in any country, and topline results announced by press release ahead of full peer-reviewed publication (as with the initial SYNCHRONIZE-1 announcement) carry the standard caveats of sponsor-reported interim data.
Program scope
Survodutide's obesity program spans five Phase 3 trials: SYNCHRONIZE-1 and SYNCHRONIZE-2 (with and without type 2 diabetes, respectively), SYNCHRONIZE-CVOT (cardiovascular disease/chronic kidney disease sub-population), and region-specific trials in Japan and China.[6] SYNCHRONIZE-2 results, in adults with obesity and type 2 diabetes, were expected later in 2026 as of this writing.
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