LivingGLP1
Study S002481

Early GLP-1 Receptor Agonist and SGLT2 Inhibitor Add-On Strategies in Adults With Obesity, Type 2 Diabetes, Cardiovascular-Kidney-Metabolic Syndrome Stage 2-3, and Metabolic Dysfunction-Associated Steatotic Liver Disease: A Target Trial Emulation

ClinicalTrials.gov recordStudy Protocol and Statistical Analysis Plan (PDF)

Registration

Registration
NCT07566299
Study type
OBSERVATIONAL
Status
COMPLETED
Enrollment
118805
Start
2017-01-01
Primary completion
2026-03-31
Lead sponsor
Chung Shan Medical University
Conditions
Obesity Type 2 Diabetes Mellitus; Cardiovascular-kidney-metabolic Syndrome; Metabolic Dysfunction-Associated Steatotic Liver Disease
Results posted
TRUE
Individual participant data sharing
NO

Registered primary outcomes

  • All-cause Mortality (Comparison 1) [From 90 days after treatment initiation through up to 60 months of follow-up]
  • All-cause Mortality (Comparison 2) [From 90 days after treatment initiation through up to 60 months of follow-up]
  • All-cause Mortality (Comparison 3) [From 90 days after treatment initiation through up to 60 months of follow-up]
  • All-cause Mortality (Comparison 4) [From 90 days after treatment initiation through up to 60 months of follow-up]

Linked records (13)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0006026Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis.
Sanyal AJ, The New England journal of medicine
2025Randomized trialPMID 40305708DOIregistry reference BACKGROUND:40305708
R0006102Effect of combination treatment with glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors on incidence of cardiovascular and serious renal events: population based cohort study.
Simms-Williams N, BMJ (Clinical research ed.)
2024Nonrandomized studyPMID 38663919DOIregistry reference BACKGROUND:38663919
R0007062Cardiovascular, Kidney, and Safety Outcomes With GLP-1 Receptor Agonists Alone and in Combination With SGLT2 Inhibitors in Type 2 Diabetes: A Systematic Review and Meta-Analysis.
Neuen BL, Circulation
2024Systematic reviewPMID 39210781DOIregistry reference BACKGROUND:39210781
R0018381Tirzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis.
Loomba R, The New England journal of medicine
2024Randomized trialPMID 38856224DOIregistry reference BACKGROUND:38856224
R0019647Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes.
Perkovic V, The New England journal of medicine
2024Randomized trialPMID 38785209DOIregistry reference BACKGROUND:38785209
R0008068Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.
Lincoff AM, The New England journal of medicine
2023Randomized trialPMID 37952131DOIregistry reference BACKGROUND:37952131
R0006899Primary Prevention of Cardiovascular and Heart Failure Events With SGLT2 Inhibitors, GLP-1 Receptor Agonists, and Their Combination in Type 2 Diabetes.
Wright AK, Diabetes care
2022Systematic reviewPMID 35100355DOIregistry reference BACKGROUND:35100355
R0012449A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis.
Newsome PN, The New England journal of medicine
2021Randomized trialPMID 33185364DOIregistry reference BACKGROUND:33185364
R0012673Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of randomised trials.
Sattar N, The lancet. Diabetes & endocrinology
2021Systematic reviewPMID 34425083DOIregistry reference BACKGROUND:34425083
R0015888Efficacy and safety of GLP-1 receptor agonists as add-on to SGLT2 inhibitors in type 2 diabetes mellitus: A meta-analysis.
Castellana M, Scientific reports
2019Systematic reviewPMID 31852920DOIregistry reference BACKGROUND:31852920
R0015532Combination therapy with GLP-1 receptor agonist and SGLT2 inhibitor.
DeFronzo RA, Diabetes, obesity & metabolism
2017Narrative reviewPMID 28432726DOIregistry reference BACKGROUND:28432726
R0022060Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.
Marso SP, The New England journal of medicine
2016Randomized trialPMID 27295427DOIregistry reference BACKGROUND:27295427
R0022278Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.
Marso SP, The New England journal of medicine
2016Randomized trialPMID 27633186DOIregistry reference BACKGROUND:27633186