{"id":"survodutide","name":"Survodutide","aliases":["BI 456906","GLP-1/glucagon dual agonist","Boehringer Ingelheim / Zealand"],"url":"https://lyoresearch.com/compounds/survodutide","summary":"Survodutide is a once-weekly peptide that activates both the GLP-1 and glucagon receptors. In SYNCHRONIZE-1, a 725-person phase 3 trial published in June 2026, it produced 12–13% weight loss at 76 weeks against 5% on placebo, with gastrointestinal symptoms in up to 90% of participants. Its distinctive result is in the liver: a phase 2 trial resolved MASH without worsening fibrosis in 83% of patients at the top dose. It is not approved anywhere.","overall_grade":"B","overall_grade_meaning":"probable, not settled","human_trials":"Phase 3 published","regulatory_status":"Investigational","outcomes":[{"outcome":"Body weight","grade":"B","grade_meaning":"probable, not settled","effect_size":"moderate","adverse":false,"human_studies":"1 phase 3 RCT + phase 2","evidence":"SYNCHRONIZE-1, 725 adults, 76 weeks: −12% (3.6 mg) and −13% (6.0 mg) versus −5% placebo; at least 5% loss in 73%, 72% and 46%. Phase 2: up to −14.9% at 46 weeks.","references":[{"citation":"Survodutide in adults with obesity: SYNCHRONIZE-1, a randomised, double-blind, placebo-controlled phase 3 trial.","where":"N Engl J Med, published online 7 June 2026","url":"https://pubmed.ncbi.nlm.nih.gov/?term=survodutide+SYNCHRONIZE-1"},{"citation":"le Roux CW, et al. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial.","where":"Lancet Diabetes Endocrinol, 2024","url":"https://pubmed.ncbi.nlm.nih.gov/?term=survodutide+obesity+phase+2+le+Roux"}]},{"outcome":"Liver disease (MASH resolution)","grade":"B","grade_meaning":"probable, not settled","effect_size":"large","adverse":false,"human_studies":"1 phase 2 RCT; phase 3 running","evidence":"Phase 2 in 293 patients: MASH improvement without worsening fibrosis in 83% at 4.8 mg versus 18% on placebo at 48 weeks; fibrosis improvement in 52% versus 26%. Phase 3 LIVERAGE ongoing.","references":[{"citation":"Sanyal AJ, et al. A phase 2 randomized trial of survodutide in MASH and fibrosis.","where":"N Engl J Med, 2024; DOI 10.1056/NEJMoa2401755","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2401755"}]},{"outcome":"Liver fat and visceral fat","grade":"B","grade_meaning":"probable, not settled","effect_size":"large","adverse":false,"human_studies":"Phase 3 (SYNCHRONIZE-MASLD)","evidence":"Marked reductions in liver fat and visceral fat reported in the phase 3 obesity-with-MASLD trial; consistent with the glucagon component's hepatic action.","references":[{"citation":"Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a phase 3 trial.","where":"2026","url":"https://pubmed.ncbi.nlm.nih.gov/42252333/"}]},{"outcome":"GI side effects","grade":"B","grade_meaning":"probable, not settled","effect_size":"large","adverse":true,"human_studies":"Phase 3","evidence":"Mild-to-moderate gastrointestinal symptoms in 81% (3.6 mg) and 90% (6.0 mg) versus 48% on placebo in SYNCHRONIZE-1, with substantial discontinuation.","references":[{"citation":"Survodutide in adults with obesity: SYNCHRONIZE-1, a randomised, double-blind, placebo-controlled phase 3 trial.","where":"N Engl J Med, published online 7 June 2026","url":"https://pubmed.ncbi.nlm.nih.gov/?term=survodutide+SYNCHRONIZE-1"}]},{"outcome":"Heart rate increase","grade":"B","grade_meaning":"probable, not settled","effect_size":"small","adverse":true,"human_studies":"Phase 2 + 3","evidence":"Resting heart rate rises a few beats per minute, as with other glucagon-receptor agonists; long-term significance unknown.","references":[{"citation":"le Roux CW, et al. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial.","where":"Lancet Diabetes Endocrinol, 2024","url":"https://pubmed.ncbi.nlm.nih.gov/?term=survodutide+obesity+phase+2+le+Roux"}]}],"regions":[{"region":"European Union","status":"Investigational; not authorised","note":"Phase 3; no marketing authorisation. Supply outside trials is unlawful."},{"region":"United States","status":"Investigational; not approved","note":"Phase 3; FDA has warned sellers marketing 'research' survodutide for human use. Cannot be compounded."},{"region":"United Kingdom","status":"Unlicensed","note":"Investigational; supply outside trials is an offence."},{"region":"Australia","status":"Unapproved","note":"Not on the ARTG; no lawful supply outside trials."},{"region":"Canada","status":"Not authorised","note":"Investigational; no DIN."},{"region":"Sport (WADA)","status":"Prohibited at all times","note":"Unapproved anywhere, so it falls under S0 (non-approved substances)."}],"faq":[{"q":"How much weight does survodutide cause people to lose?","a":"In the phase 3 SYNCHRONIZE-1 trial, 12–13% over 76 weeks against 5% on placebo — less than tirzepatide's roughly 20% in its own trials, though trials are not directly comparable."},{"q":"Why is survodutide talked about for liver disease?","a":"Because its glucagon component acts on the liver. In a phase 2 trial, 83% of patients on the top dose had MASH resolve without worsening fibrosis, against 18% on placebo — among the strongest liver results of any drug in the class."},{"q":"Is survodutide available?","a":"No. It is investigational everywhere. The FDA has specifically warned companies selling it as a research chemical for human use."}],"references":[{"cite":"Survodutide in adults with obesity: SYNCHRONIZE-1, a randomised, double-blind, placebo-controlled phase 3 trial.","where":"N Engl J Med, published online 7 June 2026","url":"https://pubmed.ncbi.nlm.nih.gov/?term=survodutide+SYNCHRONIZE-1","note":"725 adults, 76 weeks, 3.6 mg and 6.0 mg versus placebo."},{"cite":"le Roux CW, et al. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial.","where":"Lancet Diabetes Endocrinol, 2024","url":"https://pubmed.ncbi.nlm.nih.gov/?term=survodutide+obesity+phase+2+le+Roux","note":"387 adults, 46 weeks."},{"cite":"Sanyal AJ, et al. A phase 2 randomized trial of survodutide in MASH and fibrosis.","where":"N Engl J Med, 2024; DOI 10.1056/NEJMoa2401755","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa2401755","note":"293 patients, 48 weeks."},{"cite":"Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a phase 3 trial.","where":"2026","url":"https://pubmed.ncbi.nlm.nih.gov/42252333/","note":"Liver-fat and visceral-fat outcomes."}],"last_reviewed":"2026-09-03","literature_searched_to":"2026-09-03","changelog":[{"date":"2026-09-03","note":"Initial publication from SYNCHRONIZE-1 and the phase 2 MASH trial."}],"license":"CC BY 4.0 — cite as “LYO Research” with a link.","methodology":"https://lyoresearch.com/methodology"}