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

What Was Tested

The trial (phase 3) is built around Mazdutide.

The primary objective is to determine whether 76 weeks of mazdutide treatment can slow cognitive and functional decline compared with placebo in this population.

It had two arms (groups): Mazdutide group (experimental) and Placebo group (placebo comparator).

Participants will receive weekly subcutaneous injections of matched placebo, in addition to their existing glucose-lowering therapy.

The registry classes the interventions as drug.

More on the Plan

Participants will be randomized 1:1 to receive once-weekly subcutaneous mazdutide or matching placebo in addition to background glucose-lowering therapy.

The primary outcome is the between-group difference in change from baseline to Week 76 in the Integrated Alzheimer's Disease Rating Scale (iADRS) score.

Exploratory outcomes include blood-based biomarkers, amyloid PET/MRI, CDR-based clinical stage progression, resting-state functional connectivity, and additional cardiometabolic and body-composition measures.

Safety and tolerability will be assessed throughout the treatment period.

Who Took Part

The registry lists 420 planned participants were the target.

It was open to people of any sex aged from 50 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of type 2 diabetes according to the American Diabetes Association criteria;. Aged 50-75 years (inclusive), male or female. Early-stage cognitive impairment (defined as mild cognitive impairment or mild dementia), with all of the following:. MMSE score \>20 and \<27,. CDR global score 0.5-1.0 (inclusive), with a CDR memory subscore ≥0.5,.

The full record lists 17 inclusion and 23 exclusion criteria; among the exclusions: acute hyperglycemic/hypoglycemic events within 1 year, including: diabetic ketoacidosis (dka), hyperosmolar hyperglycemic state (hhs), and hypoglycemic coma; use of glp-1 receptor agonists, dual gip/glp-1 receptor agonists, dual glp-1/glucagon receptor agonists, or triple gip/glp-1/glucagon receptor agonists within 3 months before screening;; medullary thyroid carcinoma (mtc), pancreatitis.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Mazdutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Mazdutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-09-27 with completion listed for 2029-08-01.

It ran at 8 sites in China (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Integrated Alzheimer's Disease Rating Scale (iADRS) Score Change (time frame: From Baseline to Week 76).

It also tracked 13 secondary outcomes, for example Mini-Mental State Examination (MMSE) Score Change, Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score Change, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score Change, Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Score Change, Change in Total Brain Volume and Change in Total White Matter Lesion Volume.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Mazdutide in 420 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, all human trials.