Survodutide (BI 456906)
Survodutide (BI 456906); dual glucagon receptor (GCGR) / glucagon-like peptide-1 receptor (GLP-1R) agonist
Investigational drug in Phase 3 clinical trials (Boehringer Ingelheim) for obesity and MASH. Not yet FDA-approved.
An investigational once-weekly injection being developed for obesity and MASH (a serious form of fatty liver disease that can lead to liver damage). A clinical trial showed it resolved the liver condition in 62% of patients versus 14% on placebo, one of the strongest results seen for any fatty liver treatment. This medication is not yet approved.
This entry is a cited research summary, not an established treatment reference. Dosing language is included as source context, not as medical instruction.
Safety Summary
Gastrointestinal adverse events are the predominant safety concern with survodutide and are a class effect of GLP-1R agonism, compounded by GCGR activity. Incidence is dose-dependent and highest during dose-escalation phases. Titration strategies are used in all clinical protocols to mitigate GI tolerability. Overall AE rates were 91% survodutide vs 75% placebo in one dose-finding trial. SAE rates (4-8%) were similar to placebo. Treatment discontinuation due to AEs was 15-25%, predominantly due to GI events. No clinically important immunogenicity (anti-drug antibody) signal was reported (PMC12184113). Preclinical carcinogenicity studies showed thyroid C-cell tumors in rodents (class effect for GLP-1R agonists) at high exposures; no signal in non-rodent species (monkey), and no human pharmacovigilance cancer signal through early 2026 (PMC9679702; FAERS data). Preclinical monkey studies showed mild myocardial changes (vacuolation) at supratherapeutic doses with identified NOAEL (PMC9679702). No clinical QT signal reported. Pharmacodynamic drug interaction risk: delayed gastric emptying may alter absorption of narrow-therapeutic-index oral drugs (DrugBank DB18989; PMC12052016). Long-term tolerance: sustained efficacy through Week 76 without clear tachyphylaxis (PMC12803687; dom DOI 10.1111/dom.70196). Withdrawal: no dedicated discontinuation trials; class-level evidence suggests metabolic/weight rebound after stopping GLP-1 therapy (Lancet eClinicalMedicine DOI S2589-5370(25)00614-5) (NEJM DOI 10.1056/NEJMoa2401755; PMC10844353; PMC9679702; PMC12184113).
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Sources: [1-15]