Boehringer Ingelheim reported detailed Phase III results for survodutide (BI 456906), a glucagon/GLP-1 receptor dual agonist licensed from Denmark-based Zealand Pharma (Nasdaq: ZEAL), showing that the drug produced substantial reductions in visceral and liver fat alongside meaningful weight loss. The detailed Phase III analyses, presented at ADA 2026, extends previously reported weight-loss findings and strengthening the case for the glucagon/GLP-1 dual agonist in obesity and metabolic liver disease. The full results have also been published in The New England Journal of Medicine and Nature Medicine.
Trial data
The SYNCHRONIZE-1 trial is a Phase III, double-blind, placebo-controlled study enrolling 725 adults with obesity or overweight without type 2 diabetes, evaluating weekly subcutaneous survodutide at 3.6 mg or 6.0 mg versus placebo over 76 weeks. The trial met both co-primary endpoints: participants achieved up to 16.6% mean weight loss using the efficacy estimand versus 3.2% on placebo (p < 0.0001). In a pre-specified MRI sub-study, survodutide produced a relative reduction of up to 34% in visceral fat and up to 63.1% in liver fat, while lean mass accounted for no more than 10.8% of total tissue mass change at the highest dose — a body composition profile that distinguishes it from agents where lean mass loss is more pronounced. In the separate SYNCHRONIZE-MASLD trial, a Phase III, double-blind, placebo-controlled 48-week study enrolling 218 adults with overweight or obesity and MASLD with evidence of inflammation or fibrosis, 84.2% of survodutide-treated participants achieved at least a 30% relative liver fat reduction versus 24.3% on placebo (p < 0.0001), and 61% reached liver fat normalization (content < 5%) compared with 5.7% on placebo. Weight loss reached up to 12.2% versus 1.0% on placebo. Gastrointestinal events were the most common adverse effects — nausea, vomiting, diarrhea, and constipation — consistent with GLP-1 class effects; discontinuation due to GI events was 19% in SYNCHRONIZE-1 versus 2.9% on placebo, a rate that warrants attention in any future prescribing context.
Competitive context
