Survodutide

Survodutide is a dual glucagon/GLP-1 receptor agonist being developed by Boehringer Ingelheim for obesity and non-alcoholic steatohepatitis (NASH). The glucagon component may increase energy expenditure while GLP-1 reduces appetite.

PubMed results: 59 · Human studies: 38 · Animal studies: 38

Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.

Doses studied in published research. Information presented for research purposes only, not a recommendation for human use.

• Subcutaneous — standard range 2.4–4.8 mg once weekly (Phase 2 obesity dose-ranging), Once weekly. Phase 2 obesity trial (le Roux et al., NEJM) used once-weekly subcutaneous dose arms of 0.6, 2.4, 3.6, and 4.8 mg after titration, with ~20-week escalation and multi-month maintenance. Phase 3 SYNCHRONIZE programs have studied 3.6 mg and 6.0 mg once weekly. Separate Phase 2 programs evaluated survodutide in MASH/NASH. GI adverse events were dose-related and consistent with incretin dual-agonist class effects.

6 days (steady-state; ~100+ h) (high confidence)

Phase I PK for BI 456906 (survodutide) reported geometric mean terminal half-life independent of dose and greater than 100 hours after subcutaneous dosing, supporting once-weekly administration; clinical summaries also state plasma half-life of approximately 6 days. Acylated dual GCGR/GLP-1R agonist with high albumin binding.

• Body weight reduction in obesity research (Moderate clinical): Clinical development by Boehringer Ingelheim has shown meaningful weight-loss endpoints with dual glucagon/GLP-1 receptor agonism in adults with overweight or obesity.
• Metabolic and hepatic research in MASH/NASH (Moderate clinical): Survodutide is under investigation for metabolic dysfunction–associated steatohepatitis (MASH); dual agonism is studied for effects on hepatic fat, fibrosis-related markers, and metabolic parameters.
• Energy expenditure and appetite pathway dual mechanism (Limited): Research framing attributes GLP-1 pathway activity to appetite reduction and glucagon receptor activity to potential increases in energy expenditure, differentiating it from GLP-1-only agonists.

• Gastrointestinal effects (nausea, vomiting, diarrhea) — Mild, Common. Incretin-class GI adverse events are commonly reported in dual GLP-1/glucagon agonist trials, typically most prominent during dose escalation.
• Decreased appetite — Mild, Common. Appetite suppression is an expected pharmacodynamic effect of GLP-1 receptor engagement and is frequently observed alongside weight-related trial endpoints.
• Injection site reactions — Mild, Uncommon. Subcutaneous investigational dosing has been associated with local injection-site reactions in clinical development programs.

• Personal or family history of medullary thyroid carcinoma (MTC) (Established): Agents with GLP-1 receptor agonist activity carry class concern based on rodent C-cell tumor findings; dual glucagon/GLP-1 agonists are expected to inherit MTC-related restrictions under class labeling principles.
• Multiple Endocrine Neoplasia syndrome type 2 (MEN2) (Established): MEN2 elevates MTC risk; GLP-1 pathway agonists are typically contraindicated in this population pending product-specific labeling at approval.

Lyophilized (powder): Refrigerated (2-8°C), Up to 24 months. Light sensitive: yes, store dark

Reconstituted (solution): Refrigerated (2-8°C), 4-6 weeks. Solvent: Bacteriostatic water

• NCT06077864 — A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT) (PHASE3), status: ACTIVE_NOT_RECRUITING. Indications: Obesity
• NCT06564441 — A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity (PHASE1), status: COMPLETED. Indications: Overweight, Obesity
• NCT05896384 — A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood (PHASE1), status: COMPLETED. Indications: Healthy
• NCT06632457 — LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis (PHASE3), status: RECRUITING. Indications: Metabolic Dysfunction Associated Steatohepatitis
• NCT06214741 — A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight (PHASE3), status: COMPLETED. Indications: Obesity, Overweight
• NCT06352411 — A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems (PHASE1), status: COMPLETED. Indications: Healthy, Renal Impairment
• NCT06200467 — A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity (PHASE1), status: COMPLETED. Indications: Overweight, Obesity
• NCT06176365 — A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease (PHASE3), status: COMPLETED. Indications: Obesity
• NCT07413913 — A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector (PHASE1), status: RECRUITING. Indications: Healthy, Obesity
• NCT04667377 — A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight (PHASE2), status: COMPLETED. Indications: Obesity
• NCT06632444 — LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis (PHASE3), status: RECRUITING. Indications: Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
• NCT06066528 — A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight (PHASE3), status: ACTIVE_NOT_RECRUITING. Indications: Obesity, Diabetes Mellitus, Type 2
• NCT07206290 — Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease (PHASE2), status: NOT_YET_RECRUITING. Indications: Chronic Kidney Disease
• NCT06772532 — A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body (PHASE1), status: COMPLETED. Indications: Healthy
• NCT06309992 — A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (PHASE3), status: COMPLETED. Indications: Obesity, Non-Alcoholic SteatoHepatitis (NASH)
• NCT06066515 — A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight (PHASE3), status: COMPLETED. Indications: Obesity
• NCT05202353 — A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver (PHASE1), status: RECRUITING. Indications: Obesity
• NCT06745284 — A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity (PHASE1), status: RECRUITING. Indications: Obesity
• NCT06492135 — A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body (PHASE1), status: COMPLETED. Indications: Overweight, Obesity
• NCT05296733 — A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906 (PHASE1), status: COMPLETED. Indications: Healthy, Liver Diseases, Obesity