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GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Summary
The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 420 type 2 diabetes patients with early dementia are randomized 1:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential disease-modifying effects of mazdutide on cognitive dysfunction in type 2 diabetes.
Official title: Efficacy, Safety, and Tolerability of a GLP-1/GCG Dual Receptor Agonist in Type 2 Diabetes With Early Dementia: A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Trial
Key Details
Gender
All
Age Range
50 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
420
Start Date
2025-09-27
Completion Date
2029-08-01
Last Updated
2026-03-05
Healthy Volunteers
No
Interventions
Mazdutide
Mazdutide injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week. The starting dose is 2.0 mg administered once weekly (QW). Based on individual patient tolerance, the dose should be gradually increased to the target therapeutic dose of 4.0 mg QW over a period of 4 to 12 weeks. The protocol permits adaptive dose escalation up to 6.0 mg weekly when clinically indicated. For participants unable to tolerate dose increases, treatment continue at their maximum tolerated dose. The total intervention duration is 76 weeks.
Placebo
Placebo injection (pre-filled auto-injector pen) is administered subcutaneously at the same time each week. The starting dose is 2.0 mg administered once weekly (QW). Based on individual patient tolerance, the dose should be gradually increased to the target therapeutic dose of 4.0 mg QW over a period of 4 to 12 weeks. The protocol permits adaptive dose escalation up to 6.0 mg weekly when clinically indicated. For participants unable to tolerate dose increases, treatment continue at their maximum tolerated dose. The total intervention duration is 76 weeks.
Locations (8)
Department of Endocrinology, Xiangya Hospital of Central South University
Changsha, Hunan, China
Department of Endocrinology, Changzhou No.2 People's Hospital
Changzhou, Jiangsu, China
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China
Department of Endocrinology, Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Department of Endocrinology, Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Department of Endocrinology, Huadong Hospital Affiliated to Fudan University
Shanghai, China