Efficacy, Safety, and Tolerability of a GLP-1/GCG Dual Receptor Agonist in Type 2 Diabetes With Early Dementia: A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Trial

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. A total of 420 type 2 diabetes patients with early dementia are randomized 1:1 to either the active treatment group (receiving subcutaneous injections of mazdutide weekly, with stepwise dose escalation to a maintenance dose per protocol) or the placebo group (receiving matched placebo injections). The primary objective is to evaluate the potential disease-modifying effects of mazdutide on cognitive dysfunction in type 2 diabetes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 75
Healthy Volunteers: f
View:

• Type 2 diabetes mellitus (T2DM).

• Aged 50-75 years (inclusive), male or female.

• Early symptomatic dementia (Mild cognitive impairment or mild dementia), defined as:

‣ MMSE score \>20 and \<27,

⁃ CDR global score 0.5-1.0 (inclusive), with a CDR memory subscore ≥0.5,

⁃ Subjective memory complaints for ≥6 months.

• Stable glycemic control regimen for ≥3 months prior to screening, meeting one of the following:

‣ Lifestyle/dietary intervention alone (no glucose-lowering drugs),

⁃ Oral antidiabetic drugs (OADs), with or without once-daily basal insulin.

• HbA1c 7.0-9.0% (inclusive) at screening.

• BMI ≥20 kg/m², with stable weight (fluctuation \<5%) for ≥3 months.

• Stable treatment regimen for cognitive impairment for at least 3 months prior to screening and commit to its continuation throughout the study period, meeting one of the following criteria:

‣ No treatment: Not receiving any pharmacological or non-pharmacological interventions for cognitive impairment;

⁃ Non-pharmacological therapy only: Engaged exclusively in non-drug interventions (e.g., cognitive training);

⁃ Pharmacological therapy: Using approved symptomatic cognitive-enhancing medications (e.g., cholinesterase inhibitors, NMDA receptor antagonists), excluding disease-modifying therapies for Alzheimer's disease (AD).

• Ability to comply with systematic cognitive and functional assessments.

• Fully understands the trial protocol, voluntarily signs the informed consent form (ICF), and agrees to adhere to all study requirements and restrictions.

Locations
Other Locations
China
Department of Endocrinology, Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Department of Endocrinology, Changzhou No.2 People's Hospital
NOT_YET_RECRUITING
Changzhou
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
RECRUITING
Nanjing
Department of Endocrinology, Jiangsu Province Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Nanjing
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Department of Endocrinology, Huadong Hospital Affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Department of Endocrinology, Shanghai General Hospital
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Yan Bi, MD, PhD
biyan@nju.edu.cn
6-25-83-105302.
Backup
Zhou Zhang, MD, PhD
zhangzhou@smail.nju.edu.cn
86-25-83-105302
Time Frame
Start Date: 2025-09-27
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 420
Treatments
Experimental: Mazdutide group
Participants will receive weekly subcutaneous injections of mazdutide (starting at 2.0 mg, with stepwise dose escalation to a target maintenance dose of 4.0 mg and optional adaptive increase to 6.0 mg if necessary and tolerated) , in addition to their existing glucose-lowering therapy.
Placebo_comparator: Placebo group
Participants will receive weekly subcutaneous injections of matched placebo, in addition to their existing glucose-lowering therapy.
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu Province Hospital of Traditional Chinese Medicine, Huadong Hospital, Changzhou No.2 People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Nanjing First Hospital, Nanjing Medical University, Xiangya Hospital of Central South University
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov