Survodutide
Survodutide is an investigational once-weekly injection from Boehringer Ingelheim acting on glucagon and GLP-1 receptors, studied for obesity and liver disease.
US regulatory status
Investigational, not approved
Survodutide is investigational and not approved by the FDA for any use. Boehringer Ingelheim has completed phase 3 obesity trials (SYNCHRONIZE-1 and -2, published in 2026) and is running phase 3 trials in MASH, a form of fatty liver disease; we found no FDA filing as of October 16, 2026. The FDA has warned companies selling survodutide falsely labeled “for research purposes” or “not for human consumption.”
At a glance
- Also known as
- BI 456906
- Supplied as
- Several forms, depending on the product
- Research
- Limited human evidence
- US status
- US status: Investigationalchecked
What the research shows
Evidence grade
Limited human evidence
Some studies in people, but they are small, short, early-phase or uncontrolled.
Two 76-week phase 3 trials have been published. In SYNCHRONIZE-1, 725 adults with obesity and no diabetes (average weight 108.8 kg) changed weight by −12.2% and −13.0% on the two doses tested, compared with −5.4% on placebo, and 72.6% and 71.9% lost at least 5% of their weight, compared with 46.3%. In SYNCHRONIZE-2, 752 adults with type 2 diabetes changed weight by −8.2% and −9.8%, compared with −3.9%, and HbA1c (baseline 7.4%) fell by 0.9 and 0.8 points, compared with 0.2. In the 48-week SYNCHRONIZE-MASLD trial in 216 adults with obesity and fatty liver disease, 68.5% cut their liver fat by at least 30%, compared with 28.6% on placebo. In a phase 2 trial in people with MASH and liver scarring, the liver disease improved without worsening scarring in 43% to 62% across doses, compared with 14% on placebo. Boehringer Ingelheim funded all of these trials.
How we grade evidence
Strong human evidence
Consistent results from large randomized controlled trials in people.
Limited human evidence · this page
Some studies in people, but they are small, short, early-phase or uncontrolled.
Mixed evidence
Studies in people disagree, or strong evidence for one use sits beside weak evidence for another.
Animal or lab studies only
Studied in cells or animals, not properly in people. Animal results may not apply to humans.
The grade describes how much research exists and in whom. It is not a judgment that a compound works or is safe.
Side effects and safety
Stomach and bowel side effects were the most common problem in every trial. In SYNCHRONIZE-1 they affected 80.9% and 89.7% of people on the two doses tested, compared with 47.9% on placebo, and were typically mild to moderate; no deaths were reported. In the phase 2 MASH trial, nausea (66% vs 23%), diarrhea (49% vs 23%) and vomiting (41% vs 4%) were more frequent than on placebo, while serious adverse events were similar (8% vs 7%). Survodutide has no FDA label, so there is no official list of warnings or of who should not use it. The FDA says products sold as “research” survodutide are of unknown quality and may be harmful.
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Questions people ask
What is survodutide?
Survodutide is an investigational medicine that acts on two hormone receptors, glucagon and GLP-1, rather than GLP-1 alone. It is given as a once-weekly injection under the skin and is being studied for obesity and related diseases, especially fatty liver disease. It is developed by Boehringer Ingelheim; its earlier code name was BI 456906.
Sources
- N Engl J Med, 2026: Survodutide Once Weekly for the Treatment of Adults with Obesity (opens in a new tab)
- Nat Med, 2026: Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial (opens in a new tab)
- Lancet Diabetes Endocrinol, 2024: Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial (opens in a new tab)
Is survodutide FDA approved?
No. Survodutide is not approved by the FDA for any use, and no survodutide product appears on the FDA’s 2026 list of novel drug approvals. Its phase 3 obesity trials have been published, and we found no FDA filing as of October 16, 2026. The FDA has warned companies that sold survodutide labeled “for research purposes” or “not for human consumption” directly to consumers, and urges people not to buy these products.
Sources
- U.S. Food and Drug Administration, 2026: Novel Drug Approvals for 2026 (opens in a new tab)
- U.S. Food and Drug Administration, 2026: FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (opens in a new tab)
- N Engl J Med, 2026: Survodutide Once Weekly for the Treatment of Adults with Obesity (opens in a new tab)
How much weight did people lose on survodutide in trials?
In SYNCHRONIZE-1 (76 weeks, adults without diabetes), average weight change was −12.2% and −13.0% on the two doses tested, compared with −5.4% on placebo. In SYNCHRONIZE-2 (adults with type 2 diabetes), it was −8.2% and −9.8%, compared with −3.9%. Company news and some papers also report a second, larger figure that assumes everyone kept taking the medicine: in SYNCHRONIZE-MASLD, weight change was −12.2% on that basis, but −8.7% counting everyone, whether or not they kept taking it (−1.0% and −1.4% on placebo). The figures on this page count everyone. The trials above compared survodutide with placebo, not with another medicine.
Sources
- N Engl J Med, 2026: Survodutide Once Weekly for the Treatment of Adults with Obesity (opens in a new tab)
- N Engl J Med, 2026: Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes (opens in a new tab)
- Nat Med, 2026: Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial (opens in a new tab)
What are the side effects of survodutide?
Mostly digestive. In SYNCHRONIZE-1, stomach and bowel side effects affected 80.9% and 89.7% of people on the two doses tested, compared with 47.9% on placebo; in SYNCHRONIZE-2, 72.8% and 77.7%, compared with 38.6%. They were generally mild to moderate and transient. In the phase 2 obesity trial, they affected 75% of people on survodutide and 42% on placebo across the doses tested. Because survodutide has no FDA label, its full safety profile and long-term risks are not yet known.
Sources
- N Engl J Med, 2026: Survodutide Once Weekly for the Treatment of Adults with Obesity (opens in a new tab)
- N Engl J Med, 2026: Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes (opens in a new tab)
- Lancet Diabetes Endocrinol, 2024: Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial (opens in a new tab)
Does survodutide help fatty liver disease?
It is being studied for it. In SYNCHRONIZE-MASLD, 216 adults with obesity and fatty liver disease were treated for 48 weeks: 68.5% on survodutide cut their liver fat by at least 30%, compared with 28.6% on placebo; the authors note the short duration and that it ran only in the United States and Spain. In a 48-week phase 2 trial in 293 people with MASH and liver scarring, MASH improved without worsening scarring in 43% to 62% across doses, compared with 14% on placebo. Larger phase 3 MASH trials, LIVERAGE and LIVERAGE-Cirrhosis, were still recruiting as of October 16, 2026.
Sources
- Nat Med, 2026: Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trial (opens in a new tab)
- N Engl J Med, 2024: A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis (opens in a new tab)
- ClinicalTrials.gov, 2026: LIVERAGE: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Scarring, NCT06632444 (opens in a new tab)
- ClinicalTrials.gov, 2026: LIVERAGE-Cirrhosis, NCT06632457 (opens in a new tab)
Sources
- Survodutide Once Weekly for the Treatment of Adults with ObesityN Engl J Med, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Survodutide Once Weekly in Adults with Obesity and Type 2 DiabetesN Engl J Med, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- LIVERAGE: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Scarring, NCT06632444ClinicalTrials.gov, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- Novel Drug Approvals for 2026U.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
- FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration, 2026 · Accessed Oct 15, 2026 (opens in a new tab)
- Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease: SYNCHRONIZE-MASLD, a randomized, double-blind, placebo-controlled phase 3 trialNat Med, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
- A Phase 2 Randomized Trial of Survodutide in MASH and FibrosisN Engl J Med, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
- Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trialLancet Diabetes Endocrinol, 2024 · Accessed Oct 16, 2026 (opens in a new tab)
- LIVERAGE-Cirrhosis, NCT06632457ClinicalTrials.gov, 2026 · Accessed Oct 16, 2026 (opens in a new tab)
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