drugset / Trial / NCT07083154
Mazdutide in Type 2 Diabetes With Early-Stage Cognitive Impairment (LIGHT-COG Study)
Phase 3
Recruiting
420 enrolled
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Changzhou No.2 People's Hospital · collabHuadong Hospital · collabJiangsu Province Hospital of Traditional Chinese Medicine · collabNanjing First Hospital, Nanjing Medical University · collabShanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collabThe Second Affiliated Hospital of Dalian Medical University · collabXiangya Hospital of Central South University · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial evaluating the efficacy and safety of mazdutide in 420 participants with type 2 diabetes (T2D) and early-stage cognitive impairment, defined as mild cognitive impairment (MCI) or mild dementia. Participants are randomized 1:1 to receive once-weekly subcutaneous mazdutide, with dose escalation according to the protocol, or matching placebo, in addition to background glucose-lowering therapy. The primary objective is to determine whether 76 weeks of mazdutide treatment can slow cognitive and functional decline compared with placebo in this population.
Timeline
- Start
- 2025-09-27
- Primary completion
- 2029-08-01
- Completion
- 2029-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mazdutide | Protein / enzyme biologic | 4 mg | Subcutaneous |