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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 61 words Secondary endpoints: 19 to 13 · Study description shortened, about 105 words · Study title shortened, about 1 wordv5 Show 3 more changesShow less
    • Secondary endpoints: 19 to 13
    • Study description shortened, about 105 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 7 to 8 Eligibility criteria expanded, about 22 words · Secondary endpoints: 16 to 19 · Collaborators: 6 to 7v4 Show 3 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 16 to 19
    • Collaborators: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  3. Phase: Phase 4 to Phase 3 Trial status: Not Yet Recruiting to Recruiting · Start date changed from estimate of Oct 1, 2025 to Sep 27, 2025 · Secondary endpoints: 25 to 16 · 1 morev3 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2025 to Sep 27, 2025
    • Secondary endpoints: 25 to 16
    • Site details revised at 7 of 7 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Aug 1, 2025 to Oct 1, 2025 Enrollment target: 432 to 420 · Study sites: 4 to 7 · Eligibility criteria expanded, about 138 words · 3 morev2 Show 6 more changesShow less
    • Enrollment target: 432 to 420
    • Study sites: 4 to 7
    • Eligibility criteria expanded, about 138 words
    • Study description expanded, about 123 words
    • Collaborators: 3 to 6
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07083154
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators: Nanjing First Hospital, Nanjing Medical University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xiangya Hospital of Central South University, Huadong Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Changzhou No.2 People's Hospital, The Second Affiliated Hospital of Dalian Medical University
Conditions Dementia, Mild, Mild Cognitive Impairment, Type 2 Diabetes
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov