Oral Presentation Australian and New Zealand Obesity Society Annual Scientific Conference 2026

Efficacy and safety of survodutide for the treatment of obesity in adults without diabetes: primary results from the SYNCHRONIZE®-1 phase 3 trial (143877)

Carel Le Roux 1 , Sean Wharton 2 , Elena Startseva 3 , Isabel Monika Kloer 3 , Samina Ajaz Hussain 3 , Anna unseld 4 , Biykem Bozkurt 5 , Jamy Ard 6 , Harold E Bays 7 , Pawel Bogdanski 8 , Elif Ekinci 9 , Ania Jastreboff 10 , Linong Ji 11 , Wataru Ogawa 12 , Sue Pedersen 13 , Kirsi Pietilainen 14 , Naveed Sattar 15 , Jochen Seufert 16 , Kaj Stenlof 17 , Andre P van Beek 18 , Roman Vangoitsenhoven 19 , Martina Brueckmann 3 , Ramy Younes 3 , Lee M Kaplan 20 , Sakshi Maheshwari 3
  1. University College Dublin, Dublin
  2. Wharton Medical Clinic, Burlington
  3. Boehringer Ingelheim International GmBH, Ingelheim am Rhein
  4. Boehringer Ingelheim Pharma GmbH & Co.KG, Ingelheim am Rhein
  5. Baylor College of Medicine, Houston
  6. Wake Forest School of Medicine, North Carolina
  7. University of Louisville School of Medicine, Louisville Ky
  8. Poznan University of Medical Sciences, Poznan
  9. University of Melbourne, Melbourne
  10. Yale Obesity Research Center, new haven
  11. Peking University, Beijing
  12. Kobe University Graduate School of Medicine, Kobe
  13. University of Calgary, Calgary
  14. University of Helsinki, Helsinki
  15. University of Glasgow, Glasgow
  16. Ulm University Hospital, Baden-Württemberg
  17. Sahlgrenska University Hospital, Gothenburg
  18. University of Groningen, Groningen
  19. KU Leuven University Hospitals , Leuven
  20. Geisel School of Medicine at Dartmouth, Hanover

Background: Obesity is a chronic disease with unmet needs beyond weight reduction. Survodutide, an investigational glucagon receptor/glucagon-like peptide-1 receptor dual agonist, previously reduced body weight in adults with obesity without type 2 diabetes (T2D).

Methods: SYNCHRONIZE-1 (NCT06066515) was a multinational, randomised, double-blind, phase 3 trial in adults aged ≥18 years with a body mass index (BMI) ≥30 kg/m² or ≥27 kg/m² with at least one obesity complication, excluding T2D. Participants were randomised 1:1:1 to survodutide 3.6 mg, survodutide 6.0 mg, or placebo for 76 weeks. Primary endpoints were percent change in body weight (BW) and achievement of a ≥5% BW reduction from baseline to Week 76. Secondary endpoints included cardiometabolic and body composition outcomes. Safety was assessed by adverse events.

Results: A total of 726 participants were randomised across 116 sites in 14 countries. At Week 76, mean percent BW change using the efficacy estimand was −15.3% with survodutide 3.6 mg, −16.6% with survodutide 6.0 mg, and −3.2% with placebo; corresponding changes using the treatment-regimen estimand were −12.2%, −13.0%, and −5.4%. Body weight reduction of ≥5% was achieved by 83.8%, 85.1%, and 38.8% of participants, respectively. Survodutide was also associated with reductions in systolic blood pressure of up to 7.9 mmHg and glycated haemoglobin of up to 0.3%. In a descriptive on-treatment analysis, up to 78.9% of participants with prediabetes achieved normoglycaemia at Week 76 versus 20.0% with placebo. In a prespecified magnetic resonance imaging subset, survodutide reduced total body fat by ~28%, visceral fat by ~34%, and liver fat by ~63%, versus 9%, 12%, and 24% with placebo, respectively. Gastrointestinal events were the most common adverse events and were mild-to-moderate and non-serious.

Conclusion: In adults with obesity without T2D, survodutide produced relevant BW reductions and improvements in cardiometabolic and adiposity measures, including liver fat, without new safety concerns.