Survodutide
Also known as · BI 456906 · GLP-1/glucagon dual agonist (Boehringer Ingelheim / Zealand Pharma)
- EvidenceClinical
- CategoryGLP-1 & incretin
- RoutesubQ
- Half-lifen.a.
01 / Dosing schedule
Cited dosing
Survodutide is an investigational once-weekly subcutaneous GLP-1/glucagon dual agonist; it is not FDA approved. Two phase 2 trials define its human dose range: 0.6-4.8 mg weekly in obesity and 2.4-6.0 mg weekly in biopsy-confirmed MASH.
Survodutide phase 2 trials — once-weekly subQ
| Phase | Dose & frequency |
|---|---|
| Obesity phase 2 arms (NCT04667377) | 0.6 mg, 2.4 mg, 3.6 mg or 4.8 mg once weekly |
| Obesity trial structure | 46 weeks total: 20 weeks dose escalation + 26 weeks dose maintenance |
| MASH phase 2 arms (NCT04771273) | 2.4 mg, 4.8 mg or 6.0 mg once weekly |
| MASH trial structure | 24-week rapid dose-escalation phase + 24-week maintenance phase |
| Per-week escalation steps | n.a. — neither publication prints the week-by-week titration |
Source indication · MASH with fibrosis F1-F3 (phase 2, NCT04771273) and obesity without diabetes (phase 2 dose-finding, NCT04667377)
- Injection frequency
- Once weekly. Obesity trial: 46 weeks. MASH trial: 48 weeks (24 weeks escalation, 24 weeks maintenance).
- Injection sites
- n.a. — both phase 2 reports state subcutaneous administration without naming an anatomical site.
02 / Reconstitution
Reconstitution reference
Not applicable: survodutide was administered as an investigational subcutaneous injection in both phase 2 trials; no reconstitution procedure is published.
03 / Overview
Protocol overview
Survodutide (BI 456906) is a once-weekly glucagon receptor and GLP-1 receptor dual agonist from Boehringer Ingelheim, in-licensed from Zealand Pharma. No human elimination half-life is reported in either phase 2 publication fetched for this page, so it is listed as n.a. here rather than repeated from secondary sources.
The obesity dose-finding trial randomised adults aged 18-75 with BMI >=27 and no diabetes to subcutaneous survodutide 0.6, 2.4, 3.6 or 4.8 mg once weekly, or placebo, for 46 weeks, structured as 20 weeks of escalation followed by 26 weeks of maintenance.
The MASH trial enrolled adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis and fibrosis stage F1-F3, testing 2.4, 4.8 and 6.0 mg once weekly with a 24-week rapid escalation phase then 24 weeks of maintenance. 6.0 mg weekly is the highest survodutide dose with published phase 2 exposure.
Neither paper prints a week-by-week titration table, so the honest presentation is target dose plus escalation window. Survodutide is in phase 3 (including the SYNCHRONIZE cardiovascular outcomes programme) and is not approved anywhere for obesity or MASH.
04 / References