RecruitingPhase 3NCT07083154

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

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

420 participants

Start Date

Sep 27, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Dementia, Mild Mild Cognitive Impairment

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.

Eligibility

Min Age: 50 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication that works on two gut hormones (GLP-1 and glucagon) can help improve memory and thinking in people who have both type 2 diabetes and early signs of dementia. Researchers want to see if better blood sugar control can also slow memory decline. **You may be eligible if...** - You are between 50 and 75 years old - You have been diagnosed with type 2 diabetes - You have mild memory or thinking problems (mild cognitive impairment or early dementia), with memory complaints lasting at least 6 months - Your blood sugar (HbA1c) is between 7.0% and 9.0% - Your diabetes treatment has been stable for at least 3 months - Your weight has been stable for at least 3 months **You may NOT be eligible if...** - You use injectable insulin other than once-daily basal insulin - You have been on certain memory medications for less than 3 months - You have a significant history of other serious illnesses - Your BMI is under 20 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMazdutide

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.

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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