Survodutide
Survodutide is an investigational weekly injection from Boehringer Ingelheim that activates both the GLP-1 and glucagon receptors. Two phase 3 obesity trials are published, and it is not approved.
Survodutide (formerly BI 456906)
Also searched as: BI 456906.
Educational information. This page does not give dosing instructions or tell you what to take. Ask a prescriber about your own care.
In plain English
Survodutide (also called BI 456906) is a once-weekly injection that acts on two hormone receptors at once: GLP-1, which lowers appetite, and glucagon. The glucagon part is thought to add to weight loss, and the company is also studying the drug in fatty liver disease (MASH).
It now has two published phase 3 obesity trials. In SYNCHRONIZE-1, adults without diabetes lost an average of 12.2% to 13.0% of their body weight after 76 weeks, versus 5.4% on placebo. In SYNCHRONIZE-2, adults with type 2 diabetes lost 8.2% to 9.8%, versus 3.9% on placebo. These are averages for everyone assigned to the medicine, including people who stopped early.
Stomach and gut side effects were common, affecting roughly 73% to 90% of people on the medicine in the two trials. Survodutide is not approved anywhere, and this atlas did not find a confirmed FDA filing. A large heart-outcomes trial has finished, but its results have not been posted.
Brand names and products
A generic name identifies the drug itself. A brand name identifies one company's product. One drug can come in several products with different forms and approved uses, so the brand name often tells you more about what a prescription is for.
No brand name is recorded for this medicine because there is no approved product.
Approved and investigational. Every use of survodutide is investigational. There is no approved product.
How it works
Survodutide is a peptide that activates two receptors: the GLP-1 receptor, which reduces appetite and slows stomach emptying, and the glucagon receptor, whose added effect on body weight is still being worked out. The dual design is the same idea as in mazdutide and retatrutide, though each drug has a different balance between its targets.
Forms and approval status
| Form | How it is taken | U.S. status |
|---|---|---|
| Survodutide injection (investigational) | Once weekly in trials. Available only inside clinical trials. | Not approved. Boehringer Ingelheim ran two phase 3 obesity trials (SYNCHRONIZE-1 and -2), both now published in the New England Journal of Medicine, plus a heart-outcomes trial the registry lists as completed. Separate trials in fatty liver disease are also listed. This atlas did not find a confirmed FDA filing. |
What the trials found
These are group averages from published trials in adults without diabetes unless stated. See how to read trial numbers before comparing.
Survodutide phase 2 (obesity)
Average change in body weight. Every bar uses one scale, 0 to 25 percent.
- People studied
- 386 treated adults with a BMI of 27 or more, without diabetes
- Length
- 46 weeks
- Compared with
- Placebo. Four survodutide groups (0.6, 2.4, 3.6 and 4.8 mg weekly), with 20 weeks of dose increases then 26 weeks at a steady amount
- What was measured
- Average change in body weight at week 46
- Analysis approach
- Analysed by the dose each person was assigned at the start; data after COVID-19-related stops were censored
- Other results
- Weight loss rose with the dose. About 60% of participants finished the 46 weeks.
- Safety
- Side effects were reported by 91% of survodutide recipients and 75% of placebo recipients, mostly in the stomach and gut (75% vs 42%). The authors concluded all tested doses were tolerated.
- Limits
- Phase 2, so groups were small and the trial was meant to find doses. Many people stopped early, and the result depends on how that was handled. Funded by the manufacturer. Group averages do not predict one person's result.
Sources: le Roux CW 2024
SYNCHRONIZE-1
Average change in body weight. Every bar uses one scale, 0 to 25 percent.
- People studied
- 725 adults with a BMI of 30 or more, or 27 or more plus an obesity-related condition, without diabetes
- Length
- 76 weeks
- Compared with
- Placebo, with lifestyle counseling in all groups. Survodutide was raised up to 3.6 mg or 6.0 mg weekly
- What was measured
- Average change in body weight at week 76
- Analysis approach
- Treatment-regimen estimand: effects of taking the medicine as assigned, allowing for early stopping, other weight-loss drugs and a long dose-increase period
- Other results
- Weight loss of at least 5%: 72.6% (3.6 mg) and 71.9% (6.0 mg) vs 46.3% with placebo.
- Safety
- Stomach and gut side effects, usually mild to moderate, occurred in 80.9% (3.6 mg) and 89.7% (6.0 mg) of participants vs 47.9% with placebo. No deaths were reported.
- Limits
- Funded by the manufacturer. The placebo group also lost a meaningful amount with counseling, so the gap to placebo is smaller than the headline figure. The two survodutide groups differed by under one percentage point on average, while the higher amount had more gut side effects. Group averages do not predict one person's result.
Sources: le Roux CW 2026
SYNCHRONIZE-2
Average change in body weight. Every bar uses one scale, 0 to 25 percent.
- People studied
- 752 adults with type 2 diabetes and a BMI of 27 or more
- Length
- 76 weeks
- Compared with
- Placebo. Survodutide was raised to 3.6 mg or 6.0 mg weekly
- What was measured
- Average change in body weight at week 76, adults with type 2 diabetes
- Analysis approach
- Treatment-regimen estimand: effects regardless of whether the regimen was stopped or interrupted, or other weight-loss therapy was used
- Other results
- Weight loss of at least 5%: 57.6% (3.6 mg) and 64.5% (6.0 mg) vs 35.1% with placebo. HbA1c (a blood sugar marker) fell by 0.9 and 0.8 percentage points from a starting 7.4%, vs 0.2 with placebo.
- Safety
- Stomach and gut side effects, generally mild to moderate and short-lived, occurred in 72.8% (3.6 mg) and 77.7% (6.0 mg) vs 38.6% with placebo.
- Limits
- Funded by the manufacturer. Weight loss here was smaller than in SYNCHRONIZE-1, which enrolled people without diabetes, so the two sets of figures should not be compared directly. Group averages do not predict one person's result.
Sources: Wharton S 2026
Safety
No FDA label exists for this medicine yet. The information below comes from published trial reports. The points below are a summary and may be incomplete.
Boxed warning and label notes
- Survodutide injection (investigational): Not applicable. Not approved.
Warnings labels describe
- Not approved, so no official label exists. Safety information is limited to trial reports.
- Because it activates the GLP-1 receptor, the safety points seen with that class are expected to be relevant, but the label that would say so does not exist yet.
Most common in trials
- Nausea
- Vomiting
- Diarrhea and other stomach and gut side effects, reported by 73% to 90% of people on the medicine across the two phase 3 trials
Less common but serious
- The published abstracts describe the common side effects as mostly mild to moderate. SYNCHRONIZE-1 reported no deaths. Details on serious events are in the full papers.
What is still unknown
- Whether and when it will be filed with the FDA. No filing was confirmed.
- Heart-outcome results. The SYNCHRONIZE-CVOT trial (5,531 adults) is listed as completed in June 2026 with no results posted.
- Long-term weight loss and safety beyond 76 weeks, and what happens after stopping.
- How it compares with tirzepatide and semaglutide in a head-to-head trial. None has been reported.
- Results in fatty liver disease. Those phase 3 trials are separate and are not summarized here.
Compiled from public information: FDA-approved labels, manufacturer websites, ClinicalTrials.gov and published journal articles. Sources are listed at the bottom of this page.
Sources
- Survodutide once weekly for the treatment of adults with obesity (SYNCHRONIZE-1) le Roux CW, et al. N Engl J Med. 2026;395(8):776-787. PMID 42253238. Funding: Boehringer Ingelheim. Journal article
- Survodutide once weekly in adults with obesity and type 2 diabetes (SYNCHRONIZE-2) Wharton S, et al. N Engl J Med. 2026. PMID 42820639. Funding: Boehringer Ingelheim. Journal article
- SYNCHRONIZE-CVOT trial record (NCT06077864) ClinicalTrials.gov identifier NCT06077864. Sponsor: Boehringer Ingelheim. Trial registry
- ClinicalTrials.gov U.S. National Library of Medicine. Trial registry
- Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial le Roux CW, et al. Lancet Diabetes Endocrinol. 2024;12(3):162-173. PMID 38330987. Funding: Boehringer Ingelheim. Journal article