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RECRUITING
NCT07083154
PHASE3

Mazdutide in Type 2 Diabetes With Early-Stage Cognitive Impairment (LIGHT-COG Study)

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

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.

Official title: Effects of Mazdutide on Cognitive Function in Patients With Type 2 Diabetes and Early-Stage Cognitive Impairment: 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

2026-09-02

Healthy Volunteers

No

Interventions

DRUG

Mazdutide

Mazdutide is administered once weekly by subcutaneous injection using a prefilled autoinjector pen, preferably on the same day each week. Treatment is initiated at 2.0 mg once weekly and up-titrated to 4.0 mg once weekly during Weeks 4-12 according to individual tolerability. After at least 4 weeks at 4.0 mg, further escalation to 6.0 mg once weekly may be considered if prespecified criteria are met. Participants who are unable to tolerate a given dose may continue treatment at the highest tolerated dose. The total treatment duration is 76 weeks.

DRUG

Placebo

Matching placebo is administered once weekly by subcutaneous injection using a prefilled autoinjector pen. Participants will undergo the same blinded titration and dose-adjustment schedule as the mazdutide group, including corresponding 2.0 mg, 4.0 mg, and, where applicable, 6.0 mg dosing levels. Participants unable to tolerate a given dosing level may remain at the highest tolerated level. The total treatment 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