survodutide mastery course
Unit 7 of 12
Clinical Trial Landscape
SYNCHRONIZE, LIVERAGE, and the full Phase 3 program
The Phase 3 Buildout
Boehringer Ingelheim is running parallel Phase 3 programs for survodutide across obesity and MASH. This unit maps the SYNCHRONIZE obesity trials, the LIVERAGE MASH program, the cardiovascular outcomes trial, and the design decisions that shape each study, including enrollment targets and expected readout timelines.
Interactive Trial Timeline
Explore the Phase 3 trial program, enrollment targets, and expected readout dates.
trial timeline explorer
key numbers
the scale of survodutide's clinical development program.
~13,000
total planned enrollment across all Phase 3 trials
3
indications: obesity, MASH, cardiovascular
8,000
CVOT enrollment (largest survodutide trial)
2027-2028
projected first approvals (MASH then obesity)
All Phase 3 trials are ongoing. Enrollment targets and readout dates are based on publicly disclosed information from Boehringer Ingelheim as of early 2026. Timelines are subject to change based on enrollment pace, interim analyses, and regulatory interactions.
key terms
clinical trial design vocabulary for this unit. tap to expand.
P
A Phase 3 trial designed to provide the primary efficacy and safety evidence for regulatory approval. Pivotal trials are typically larger, longer, and more rigorously controlled than earlier-phase studies. SYNCHRONIZE and LIVERAGE are survodutide's pivotal programs.
M
Major adverse cardiovascular events. The standard composite endpoint for cardiovascular outcomes trials. 3-point MACE includes cardiovascular death, non-fatal MI, and non-fatal stroke. The CVOT is event-driven, meaning it continues until enough MACE events have occurred for statistical power.
A
An FDA pathway that allows approval based on a surrogate endpoint (like histological improvement) rather than clinical outcomes. Requires confirmatory trials. LIVERAGE is designed with a dual endpoint to support both accelerated and traditional approval for MASH.
H
An outcome measured by liver biopsy rather than imaging or blood tests. MASH resolution and fibrosis improvement are assessed by pathologists examining tissue samples. These endpoints are considered the gold standard for MASH trials but require invasive procedures.
D
Gradually increasing the dose over time to improve tolerability. SYNCHRONIZE uses a 28-week flexible escalation to 6.0 mg, compared to the Phase 2 rapid 12-week escalation to 4.8 mg. The slower schedule was designed to reduce GI-related discontinuation.
trial program overview
the three parallel Phase 3 programs spanning obesity, MASH, and cardiovascular outcomes.
SYNCHRONIZE-1/2
twin Phase 3 obesity trials. ~3,400 patients, 76 weeks. monotherapy and adjunct arms. using 28-week flexible escalation to 6.0 mg. SYNCHRONIZE-1 read out April 28, 2026 (16.6% efficacy estimand at 76 weeks; 85.1% achieved ≥5% loss); full data at ADA June 2026.
LIVERAGE
Phase 3 MASH trial. ~1,400 patients with F2-F3 fibrosis. dual endpoint: 52-week histological assessment plus 7-year clinical outcomes. largest MASH trial for a GLP-1/GCGR agonist.
CVOT
cardiovascular outcomes trial. ~8,000 patients with established CVD. event-driven design targeting 3-point MACE. expected completion 2028. required for regulatory completeness.