- SYNCHRONIZE‑1 (n=725) Phase III: survodutide (BI 456906), a glucagon/GLP‑1 dual agonist, produced mean 16.6% weight loss at Week 76; 85.1% achieved ≥5% vs 38.8% placebo.
- Participants received weekly injections (3.6 mg or 6.0 mg) over 76 weeks; primary endpoints were met for both efficacy and treatment‑regimen estimands.
- Survodutide is licensed from Zealand Pharma and is in global Phase III programs including LIVERAGE/LIVERAGE‑Cirrhosis for MASH (fibrosis stages 2–4); a triple GLP‑1/GIP/NPY2 agonist (BI 3034701) is slated to enter Phase II mid‑2026.
Phase III SYNCHRONIZE‑1 results
SYNCHRONIZE‑1 (n=725; adults with overweight or obesity without type 2 diabetes) randomized weekly survodutide (3.6 mg or 6.0 mg) or placebo for 76 weeks; using the efficacy estimand survodutide produced mean 16.6% weight loss versus 3.2% for placebo (p<0.0001) and 85.1% achieved ≥5% weight loss versus 38.8% with placebo.
Body composition and metabolic signals
Weight reduction was driven predominantly by fat loss with only a small lean‑mass contribution; waist circumference—a marker of visceral fat and cardiometabolic risk—was significantly reduced versus placebo, indicating potential metabolic benefit; full trial data will be presented at ADA 2026 Scientific Sessions.
Safety
Adverse events were mainly gastrointestinal, generally mild to moderate and transient, with more discontinuations during dose escalation; no new safety signals beyond those expected for the GLP‑1 class were reported.
Ongoing development and pipeline
Survodutide is being evaluated across global Phase III programs including LIVERAGE and LIVERAGE‑Cirrhosis for MASH with fibrosis stages 2–4 (planned enrollments ≈1,800 and ≈1,590); the molecule is licensed from Zealand Pharma; a potential triple GLP‑1/GIP/NPY2 agonist (BI 3034701) is planned to enter Phase II mid‑2026.
