Survodutide: what the studies show

Investigational BI 456906

Survodutide, also called BI 456906, is a single glucagon and GLP-1 receptor agonist. It has no FDA-approved product as of this review. Its trials used weekly subcutaneous administration. The trial schedule does not validate use of products sold outside the trials.

Keep diabetes populations separate

The phase 3 SYNCHRONIZE-1 trial enrolled 725 adults without diabetes who had obesity or overweight with a complication. With lifestyle counseling, weight reductions at 76 weeks were 12.2% and 13.0% in the two survodutide groups, versus 5.4% with placebo.

SYNCHRONIZE-2 enrolled 752 adults with type 2 diabetes and BMI at least 27. Corresponding reductions were 8.2% and 9.8%, versus 3.9% with placebo. These separate trials studied different populations. Their percentages are not interchangeable.

How the results were analyzed

Both sets of figures use the treatment-regimen analysis, which accounts for treatment discontinuation. Analyses that assume continued treatment can estimate larger losses. Gastrointestinal events were common in both trials.

Weight reduction does not answer whether survodutide reduces cardiovascular events or how long benefits persist after stopping. Phase 3 trial results also do not validate unapproved preparations.