Evidence status · reviewed 1 August 2026
One dated view of the survodutide evidence base — the Phase 3 SYNCHRONIZE obesity and MASLD trials alongside the peer-reviewed Phase 2 obesity and MASH results — with the liver-outcome and cardiovascular-safety readouts still unpublished. Evidence state comes before headline magnitude.
Survodutide remains investigational and is not approved by any regulator. This tracker is research context, not clinical or personal-use guidance.
The statuses below describe the source available for each result, not an approval status or a judgment about clinical use.
Adults with obesity, without type 2 diabetes · Phase 3 · 76 weeks
Published in NEJM, mean body-weight change at week 76 on the treatment-regimen estimand was −12.2% (3.6 mg) and −13.0% (6.0 mg) versus −5.4% with placebo, with 72.6% and 71.9% versus 46.3% achieving at least 5% loss; the sponsor’s efficacy-estimand topline reported up to 16.6% versus 3.2% (n=725, NCT06066515).
Obesity or overweight with MASLD · Phase 3 · 48 weeks
Published in Nature Medicine, up to 84.2% of the 6.0 mg group achieved at least a 30% liver-fat reduction versus 24.3% with placebo, with mean body-weight reduction up to 12.2% versus 1.0% and liver-fat normalization in up to 61.0% versus 5.7% (efficacy estimand; NCT06309992).
Biopsy-confirmed MASH, fibrosis F1–F3 · Phase 2 · 48 weeks
Published in NEJM, MASH improvement without worsening of fibrosis occurred in 47%, 62% and 43% of the 2.4 mg, 4.8 mg and 6.0 mg groups versus 14% with placebo, with at least one-stage fibrosis improvement in 34%, 36% and 34% versus 22% (n=293, NCT04771273).
Adults with obesity, without diabetes · Phase 2 dose-finding · 46 weeks
Published in The Lancet Diabetes & Endocrinology, mean body-weight change to week 46 was −6.2%, −12.5%, −13.2% and −14.9% across the 0.6–4.8 mg doses versus −2.8% with placebo, dose-dependently (n=387, NCT04667377).
MASH with fibrosis (F2–F3) and compensated MASH cirrhosis · Phase 3 · ongoing
The pivotal Phase 3 MASH-histology trials are ongoing. Detailed results were not identified as published at this tracker’s review (NCT06632444).
Elevated weight with cardiovascular or kidney risk · Phase 3 · event-driven cardiovascular safety
The event-driven cardiovascular-safety trial reached its registry-listed actual completion on 30 June 2026. No results had been posted to the registry and no publication was identified at this tracker’s review (NCT06077864).
How to read this tracker
A full report has passed journal review and exposes methods and analyses for scrutiny.
A primary-source company release is available, but the complete paper may not yet be published.
The registry establishes design and status; it does not substitute for a results publication.
See where Survodutide sits in the wider incretin pipeline, then check the sister approval tracker on Remy Peptides.