Trial · Interventional
RecruitingPhase 3Registry dataMazdutide in Type 2 Diabetes With Early-Stage Cognitive Impairment (LIGHT-COG Study)
Overview
- Status
- Recruiting
- Phase
- Phase 3
- Enrollment
- 420 participants (estimated)
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
China
- Start
- 27 Sept 2025
- Primary completion
- 1 Aug 2029 (estimated)
- Completion
- 1 Aug 2029 (estimated)
- First posted
- 24 Jul 2025
- Last update posted
- 2 Sept 2026
- Conditions
- Dementia, Mild · Mild Cognitive Impairment · Type 2 Diabetes
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Mazdutide in Type 2 Diabetes With Early-Stage Cognitive Impairment (LIGHT-COG Study)
NCT0708315427 Sept 2025 to est. 1 Aug 2029
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- MazdutideDrug
- PlaceboDrug
Arms2
Experimental
Mazdutide group
Participants will receive once-weekly subcutaneous mazdutide, starting at 2.0 mg and titrated to 4.0 mg, with optional escalation to 6.0 mg according to prespecified criteria. Participants unable to tolerate a given dose will remain on the highest tolerated dose, in addition to background glucose-lowering therapy.
Placebo comparator
Placebo group
Participants will receive weekly subcutaneous injections of matched placebo, in addition to their existing glucose-lowering therapy.
Primary outcomes1
Outcomes the sponsor listed as primary.
Integrated Alzheimer's Disease Rating Scale (iADRS) Score Change
Time frame · From Baseline to Week 76
Registry description
The change in Integrated Alzheimer's Disease Rating Scale (iADRS) scores from baseline to Week 76 will be compared between the treatment group and the placebo group to assess the drug's potential to improve or slow cognitive decline. iADRS is a composite endpoint that integrates cognitive and functional assessments (scores from Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) and Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living(ADCS-iADL)) to generate a total score (range: 0-144). The calculation formula is: iADRS score = (85 - ADAS-Cog13 score) + ADCS-iADL score A lower score indicates more severe cognitive and functional impairment.
Secondary outcomes(13)
Mini-Mental State Examination (MMSE) Score Change
Time frame · From Baseline to Week 76
Registry description
The change in Mini-Mental State Examination (MMSE) scores from baseline to Week 76 will be compared between the treatment group and the placebo group to assess the drug's potential to improve or slow cognitive decline. It assesses multiple cognitive domains, including orientation, memory, attention and calculation, recall ability, language, and visuospatial skills. The total score ranges from 0 to 30, with higher scores indicating better cognitive function.
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score Change
Time frame · From Baseline to Week 76
Registry description
The change in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) scores from baseline to Week 76 will be compared between the treatment group and the placebo group to assess the drug's potential to improve or slow cognitive decline. The score ranges from 0 to 18, with higher scores indicating greater severity of cognitive and functional impairment.
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score Change
Time frame · From Baseline to Week 76
Registry description
The change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) scores from baseline to Week 76 will be compared between the treatment group and the placebo group to assess the drug's potential to improve or slow cognitive decline. The score ranges from 0 to 85, with higher scores indicating more significant cognitive impairment.
Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Score Change
Time frame · From Baseline to Week 76
Registry description
The change in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) scores from baseline to Week 76 will be compared between the treatment group and the placebo group to assess the drug's potential to improve or slow functional decline. The total score ranges from 0 to 59, with lower scores indicating more severe functional impairment.
Change in Total Brain Volume
Time frame · From Baseline to Week 76
Registry description
The change in total brain volume evaluated by structural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group.
Change in Total White Matter Lesion Volume
Time frame · From Baseline to Week 76
Registry description
The change in total white matter lesion volume evaluated by sturctural MRI from baseline to Week 76 will be compared between the treatment group and the placebo group.
Change in hippocampal volume
Time frame · From Baseline to Week 76
Registry description
Change from baseline to Week 76 in hippocampal volume assessed by structural brain MRI.
Change in entorhinal cortex volume
Time frame · From Baseline to Week 76
Registry description
Change from baseline to Week 76 in entorhinal cortex volume assessed by structural brain MRI.
Change in Body Weight
Time frame · From Baseline to Week 76.
Registry description
Change in body weight from baseline to weeks 76.
Change in Body Mass Index (BMI)
Time frame · From Baseline to Week 76.
Registry description
Change in BMI from baseline to week 76.
Change in Glycated Haemoglobin (HbA1c) Levels
Time frame · From Baseline to Week 76
Registry description
Change in HbA1c levels from baseline to week 76
Change in Fasting Plasma Glucose Levels
Time frame · From Baseline to Week 76
Registry description
Change in fasting plasma glucose levels from baseline to week 76
Change in 2-hour Postprandial Plasma Glucose Levels
Time frame · From Baseline to Week 76
Registry description
Change in fasting plasma glucose levels from baseline to week 76
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 50 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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