A 76-Week Phase 3 Trial Testing Mazdutide Injections for Cognitive Improvement in Adults 50-75 Years with Type 2 Diabetes and Early Dementia

What this Trial Is About

Researchers are investigating the potential effects of mazdutide, a GLP-1GCG dual receptor agonist, on cognitive dysfunction in people with type 2 diabetes and early dementia. This 76-week, multicenter, randomized, double-blind, placebo-controlled study will compare mazdutide against a placebo to evaluate whether it can modify disease progression. The trial aims to assess cognitive improvement alongside changes in brain structure, metabolic health, neurodegenerative biomarkers, and safety outcomes. Participants are randomly assigned to receive either weekly subcutaneous injections of mazdutide or a matched placebo, in addition to their current glucose-lowering treatments. The mazdutide dose starts at 2.0 mg weekly and is gradually increased to a maintenance dose of 4.0 mg, with an optional increase to 6.0 mg if needed and tolerated. If blood sugar control remains poor despite treatment, rescue therapies such as insulin glargine, metformin, or other medications may be added based on the investigators judgment. The treatment phase lasts 76 weeks. During the study, participants will undergo detailed cognitive and metabolic assessments at the start and at weeks 28, 52, and 76. Safety visits occur at week 4 and every 8 weeks thereafter to monitor side effects, adherence, and metabolic status. Advanced brain imaging and blood biomarker tests will be conducted to track changes in brain volume, amyloid plaque deposition, and neurodegeneration. The main outcome measured is the change in the Integrated Alzheimers Disease Rating Scale score over time, along with several secondary cognitive and metabolic measures.

GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)