Survodutide: the basics
What is it?
A lab-made peptide medicine being tested by Boehringer Ingelheim. It switches on two hormone signals, glucagon and GLP-1, that affect appetite, blood sugar and how the liver handles fat.
Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗What do people claim it helps with?
Weight loss, better blood sugar in type 2 diabetes, and treatment of fatty liver disease with inflammation (MASH).
What has research actually shown?
Large controlled trials found more weight loss than placebo, and a smaller trial found more improvement in MASH on liver biopsy. Results vary between people.
Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗Has this been demonstrated in people?
Phase 2 and phase 3 randomized trials in adults, paid for by the manufacturer. Liver-outcome phase 3 trials are still recruiting.
Research paper 1 ↗Research paper 2 ↗Research paper 3 ↗What side effects, risks and unknowns should I understand?
Nausea, vomiting and diarrhoea were very common in trials, more so than with placebo. Long-term safety is still being studied.
FDA safety information 1 ↗Research paper 2 ↗Is it an approved medicine?
No FDA-approved medicine contains survodutide. FDA has warned companies selling it illegally as a "research" chemical for people to use.
FDA safety information ↗Approval here means U.S. FDA approval and applies to a particular product, formulation and use. This is a starting overview, not a complete side-effect list. Sources checked 10 October 2026; independent scientific review pending.
How is it used or studied?
Tested as a once-weekly injection in clinical trials. There is no approved product; online "research" vials are not the trial medicine.
Different routes and formulations can have different effects. A study of one product does not validate every product with the same peptide name.
A common misunderstanding
Survodutide is not semaglutide or tirzepatide, and it is different from mazdutide and pemvidutide even though they target similar receptors.
What should I ask a clinician?
- What diagnosis or goal are we trying to address, and what established options are available?
- Was the expected benefit shown in people like me, using this exact product?
- How could my medicines, health conditions or pregnancy plans affect the risks?
- What monitoring is needed, and what would tell us the treatment is helping or should be stopped?
What do the research words mean?
- Peptide
- A short chain of amino acids, the building blocks of proteins.
- Preclinical
- Research in cells, tissues or animals before dependable treatment evidence in people.
- Controlled trial
- A study comparing a treatment with another treatment or a placebo to help separate its effects from other explanations.
- Biomarker
- A measurement, such as a hormone level. A change does not necessarily mean someone feels better or lives longer.
Survodutide Evidence & Clinical Profile
Human Study Limits
Survodutide has been investigated in clinical contexts. Patient outcomes must be evaluated against study size, design, and control cohorts.
Laboratory & In Vivo Assays
Cellular and animal disease models examine receptor binding affinities and signaling cascades, which require human confirmation.
What is Survodutide?
Survodutide (BI 456906) is Survodutide is an investigational once-weekly injectable peptide from Boehringer Ingelheim that activates both glucagon and GLP-1 receptors. Phase 3 obesity trials and a phase 2 liver (MASH) trial have reported benefits versus placebo, but it is not FDA-approved. Aliases include: BI 456906, BI456906, glucagon/GLP-1 dual agonist.
- Sequence (one-letter)
- N/A
- Molecular formula
- C192H289N47O61
- Molecular weight
- 4232 g/mol (PubChem computed)
- CAS Number
- 2805997-46-8
- UNII Code
- 2ALA66NS64
- PubChem CID
- 171378821
Identifiers checked against PubChem and FDA's Global Substance Registration System on 13 October 2026. FDA substance record ↗ · PubChem record ↗ See all names and codes in the peptide name index.
Clinical Trials & Human Cohorts
Human research can examine tolerability, symptoms or patient outcomes. The design and comparator determine what each result can establish.
Survodutide Once Weekly for the Treatment of Adults with Obesity [1]
What was reported
Mean weight change was −12.2% and −13.0% in the two survodutide groups versus −5.4% with placebo; about 72% versus 46% lost at least 5% of body weight.
What limits the conclusion
Gastrointestinal adverse events were very common (80.9% and 89.7% vs 47.9% with placebo). Funded by Boehringer Ingelheim.
Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes [2]
What was reported
Mean weight change was −8.2% and −9.8% versus −3.9% with placebo; HbA1c fell 0.8 to 0.9 percentage points versus 0.2 with placebo.
What limits the conclusion
Weight loss was smaller than in people without diabetes. Gastrointestinal adverse events: 72.8% and 77.7% vs 38.6%.
A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis [3]
What was reported
Improvement in MASH without worsening fibrosis occurred in 43%–62% of survodutide groups versus 14% with placebo. Fibrosis improved by at least one stage in 34%–36% versus 22% (secondary endpoint).
What limits the conclusion
Phase 2 with a 48-week treatment period; biopsy outcomes can vary. Nausea (66% vs 23%), diarrhoea and vomiting were more common than with placebo.
Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a dose-finding phase 2 trial [4]
What was reported
Mean weight change ranged from −6.2% to −14.9% across survodutide doses versus −2.8% with placebo.
What limits the conclusion
Only about 60% completed the treatment period. Gastrointestinal adverse events in 75% on survodutide vs 42% on placebo.
How the compound may work
Mechanisms describe how Survodutide may affect biological processes. Laboratory findings and patient outcomes answer different questions.
Glucagon plus GLP-1 receptor activation
Survodutide is an acylated peptide (it carries a fatty-acid chain that extends its half-life) that activates both glucagon and GLP-1 receptors. In mice it reduced body weight more than semaglutide by both lowering food intake and raising energy expenditure. These are animal findings. [5]
Liver-directed effects
In people with biopsy-confirmed MASH, survodutide improved liver disease activity and reduced liver fat versus placebo. How much of this is a direct liver effect rather than a result of weight loss is not settled by this trial. [3]
Areas Being Studied
These research topics reflect active areas of scientific exploration, distinct from unverified commercial marketing claims.
Obesity
Weight loss with and without type 2 diabetes (SYNCHRONIZE program). [1]
MASH (fatty liver disease with inflammation)
Biopsy-based MASH and fibrosis outcomes; LIVERAGE phase 3 trials are recruiting. [9]
Cardiovascular safety
SYNCHRONIZE-CVOT is listed as completed; results were not found in the peer-reviewed literature at the time of review. [8]
Compare the study designs.
| Study | Design / sample | Outcome type | Key limitation |
|---|---|---|---|
| SYNCHRONIZE-1: obesity without diabetes · 2026 [1] | Phase 3 double-blind, placebo-controlled randomized trial; 76 weeks n = 725 |
Clinical endpoint evaluation | Gastrointestinal adverse events were very common (80.9% and 89.7% vs 47.9% with placebo). Funded by Boehringer Ingelheim. |
| SYNCHRONIZE-2: obesity with type 2 diabetes · 2026 [2] | Phase 3 double-blind, placebo-controlled randomized trial; 76 weeks n = 752 |
Clinical endpoint evaluation | Weight loss was smaller than in people without diabetes. Gastrointestinal adverse events: 72.8% and 77.7% vs 38.6%. |
| Phase 2: MASH and fibrosis · 2024 [3] | Phase 2 randomized, placebo-controlled trial with liver biopsy; 48 weeks n = 293 |
Clinical endpoint evaluation | Phase 2 with a 48-week treatment period; biopsy outcomes can vary. Nausea (66% vs 23%), diarrhoea and vomiting were more common than with placebo. |
| Phase 2: obesity dose-finding · 2024 [4] | Phase 2 double-blind, placebo-controlled randomized trial; 46 weeks n = 386 |
Clinical endpoint evaluation | Only about 60% completed the treatment period. Gastrointestinal adverse events in 75% on survodutide vs 42% on placebo. |
Regulatory Status & Clinical Safety
Regulatory Classification
United States, checked 11 October 2026: not FDA-approved; no record appears in Drugs@FDA or DailyMed. FDA reports it has warned companies illegally selling unapproved drugs containing survodutide that are falsely labelled "for research purposes" or "not for human consumption".
Safety Realities & Impurities
Safety depends on the molecule, formulation, route and evidence. A laboratory purity measurement alone cannot establish safety for human use.
Clinical Trials Registry Records
Official registry records from ClinicalTrials.gov. Study registration does not imply government endorsement or guaranteed efficacy.
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight (SYNCHRONIZE-1) [6]
- Planned enrollment
- 726 (actual enrollment)
- Posted results
- Pending in registry
- Sponsor
- Boehringer Ingelheim
- Last updated
- 2026-03-12
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight (SYNCHRONIZE-2) [7]
- Planned enrollment
- 755 (actual enrollment)
- Posted results
- Pending in registry
- Sponsor
- Boehringer Ingelheim
- Last updated
- 2026-08-06
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE - CVOT) [8]
- Planned enrollment
- 5531 (actual enrollment)
- Posted results
- Pending in registry
- Sponsor
- Boehringer Ingelheim
- Last updated
- 2026-09-30
LIVERAGE: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis [9]
- Planned enrollment
- 1800 (estimated enrollment)
- Posted results
- Pending in registry
- Sponsor
- Boehringer Ingelheim
- Last updated
- 2026-10-01
WADA & Anti-Doping Regulations
WADA Anti-Doping Status
Survodutide is not prohibited under current World Anti-Doping Agency (WADA) regulations. However, athletes must ensure unregulated preparations or unverified vendor products do not violate Section S0 (Non-approved substances). Last verified: October 2026.
Research Timeline
-
2022
Preclinical profile published
Boehringer Ingelheim describes BI 456906 and its effects in mice. [5]
-
2024
Phase 2 results
Dose-finding obesity and MASH trials report weight loss and liver improvements versus placebo. [3]
-
2026
SYNCHRONIZE-1 and -2 published
Phase 3 trials report 76-week weight results with and without type 2 diabetes. [1]
-
2026
Current status
Not FDA-approved. FDA has warned sellers of survodutide falsely labelled as research products. [10]
What Researchers Still Don't Know
Long-term safety profiles
Multi-year observational data in broader heterogeneous cohorts remains uncharacterized.
Optimal dose-response thresholds
Comparative trials optimizing minimal effective exposure versus adverse event rates.
Formulation bioavailability
Differences between oral, subcutaneous, and modified peptide delivery vehicles.
References
Primary sources verified against PubMed / NLM and regulatory databases.
-
Phase 3 RCT
Survodutide Once Weekly for the Treatment of Adults with Obesity ↗ (external website)
DOI: 10.1056/NEJMoa2600751 ↗ (external website) -
Phase 3 RCT
Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes ↗ (external website)
DOI: 10.1056/NEJMoa2607219 ↗ (external website) -
Phase 2 RCT
A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis ↗ (external website)
DOI: 10.1056/NEJMoa2401755 ↗ (external website) - Phase 2 RCT DOI: 10.1016/S2213-8587(23)00356-X ↗ (external website)
- Preclinical study DOI: 10.1016/j.molmet.2022.101633 ↗ (external website)
- Registry Record
- Registry Record
- Registry Record
- Registry Record
-
FDA Safety Communication
FDA's concerns with unapproved GLP-1 drugs used for weight loss ↗ (external website)
