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
Study ID
NCT07083154
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Mazdutide — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 24, 2025
Start date
Sep 27, 2025
Status verified
Aug 2026
Primary completion
Aug 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

Integrated Alzheimer's Disease Rating Scale (iADRS) Score Change [ Time Frame: From Baseline to Week 76 ]

Central Contacts

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