VialOwlLibrary / Weight and metabolic
Survodutide
Also known as BI 456906
Human trials
Investigational dual glucagon and GLP-1 receptor agonist peptide studied for obesity and for metabolic liver disease (MASH).
Not an approved medicine. Survodutide is not an approved medicine for this use in Australia or the United States. This page summarises published research for information only. It is not a recommendation to use Survodutide, and VialOwl does not sell or supply it.
Background
Investigational once weekly peptide (BI 456906) developed by Boehringer Ingelheim with Zealand Pharma, designed to activate both the glucagon and GLP-1 receptors. It is in phase 3 trials for obesity and for fatty liver disease (MASH).
How it is thought to work
The GLP-1 action reduces appetite and slows stomach emptying, while the glucagon action increases energy use and fat burning in the liver. The combination is intended to target liver fat more directly than GLP-1 drugs alone.
What is claimed, and the evidence
| Claim | Evidence | Notes |
|---|---|---|
| Weight loss in adults with obesity | Human trials | Phase 3 SYNCHRONIZE-1 (725 people): about minus 12% to 13% at 76 weeks versus minus 5.4% on placebo. Not yet approved. |
| Improves MASH (fatty liver inflammation) and fibrosis | Human trials | Phase 2 trial in 293 people: MASH improved in 43% to 62% versus 14% on placebo; phase 3 trials ongoing. |
| More effective than approved GLP-1 medicines | No published evidence | No published head to head trials found. |
Side effects
| Effect | How often | Notes |
|---|---|---|
| Nausea | Common | 66% versus 23% on placebo in the MASH phase 2 trial. |
| Vomiting | Common | 41% versus 4% on placebo in the MASH trial. |
| Diarrhoea | Common | 49% versus 23% on placebo in the MASH trial. |
| Gastrointestinal side effects overall | Common | 81% to 90% versus 48% on placebo in the phase 3 obesity trial; mostly mild to moderate. |
| Stopping treatment because of side effects | Common | Many discontinuations in phase 2, mostly gastrointestinal. |
| Increased heart rate and other GLP-1 class risks such as gallbladder disease or pancreatitis Serious | Frequency unknown | Expected for this drug class; long term data not yet published. |
Warnings
- Investigational: not approved anywhere, so long term safety is unknown.
- FDA has warned companies selling survodutide falsely labelled 'for research purposes', saying such products are of unknown quality and may be harmful.
- Unapproved products are not made to medicine standards and may be contaminated, underdosed, overdosed or contain a different substance from the label; the TGA warns that injected unapproved peptides carry risks including contamination, infection and local tissue damage.
Regulatory status
- Australia
- Not included on the ARTG (unapproved). Not specifically listed in the Poisons Standard (June 2026).
- United States
- Not FDA approved; investigational (phase 3 SYNCHRONIZE programme). FDA has warned sellers of unapproved survodutide labelled for research use.
Sources
- Survodutide Once Weekly for the Treatment of Adults with Obesity (SYNCHRONIZE-1)
- Glucagon and GLP-1 receptor dual agonist survodutide for obesity: phase 2 trial
- A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis
- FDA: FDA's concerns with unapproved GLP-1 drugs used for weight loss
Also in Weight and metabolic
From the VialOwl library, reviewed 26 September 2026. For education and general information. It is not medical advice and not a recommendation to use Survodutide.