Dementia, MildPhase 3NCT07083154
Mazdutide in Type 2 Diabetes With Early-Stage Cognitive Impairment (LIGHT-COG Study)
A Phase 3 study testing Mazdutide in people with Dementia, Mild and Mild Cognitive Impairment, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 8 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Dementia, Mild, Mild Cognitive Impairment, Type 2 Diabetes
- What is being tested?
- Mazdutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 8 sitesChina
- Study dates
- 27 Sep 2025to 1 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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,
- A history of gradual and progressive cognitive decline for at least 6 months, reported by the participant or an informant.
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- 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.
Who cannot join
- Known or suspected neurodegenerative disorders other than AD that are likely to be a major cause of cognitive impairment or to interfere with cognitive assessment, including but not limited to frontotemporal dementia and related syndromes, dementia with Lewy bodies, Parkinson's disease with cognitive impairment or dementia, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, and Huntington's disease;
- Current diagnosis of a poorly controlled or unstable psychiatric disorder (including but not limited to schizophrenia, bipolar disorder, major depressive disorder, generalized anxiety disorder, personality disorders, etc.), which, in the investigator's judgment, may interfere with study assessments, affect treatment compliance, or increase participant risk.
- With a Patient Health Questionnaire-9 (PHQ-9) score ≥10 at screening, or a Generalized Anxiety Disorder Scale-7 (GAD-7) score ≥10 at screening.
- Ischaemic or haemorrhagic stroke, transient ischaemic attack, or epileptic seizure within 3 months before screening; or other current or clinically significant central nervous system disorders or injuries likely to impair cognitive function or interfere with cognitive assessment, including but not limited to central nervous system infection, intracranial tumour, multiple sclerosis, metabolic encephalopathy, neurological disorders related to malnutrition, or severe traumatic brain injury;
- 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;
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- Regular use (>2 doses/week) of moderate-to-strong anticholinergic drugs within 4 weeks prior to screening; Use within 3 months prior to screening of: Anti-Parkinsonian drugs, Antiepileptic drugs, Antipsychotics, Morphine and opioid analgesics (Exemption: Short-term use [<5 days] for surgery/acute injury, if completed >4 weeks before screening); Use within 4 weeks prior to screening of: CNS stimulants; Medical/recreational cannabis, cannabinoids, or cannabidiol (CBD).a. Moderate/high anticholinergics, antiparkinsonian/antiepileptic drugs.
- Alcohol abuse (defined as >21 units/week for men or >14 units/week for women; 1 unit = 360 mL beer, 150 mL wine, or 45 mL spirits).
- Medical history of:
- Medullary thyroid carcinoma (MTC), pancreatitis
- Multiple endocrine neoplasia type 2 (MEN2)
- Gallbladder/biliary disease, severe gastrointestinal disorders, or bowel resection
- Active malignancy
- Uncontrolled or potentially unstable diabetic retinopathy/maculopathy.
- Severe organ dysfunction, including:
- ALT/AST >3× upper limit of normal (ULN);
- eGFR <45 mL/min/1.73m² (CKD-EPI equation);
- History of unstable angina or myocardial infarction within 3 months before screening, or current heart failure of NYHA class II or higher.
- Known/suspected hypersensitivity to the investigational product or related compounds
- Pregnancy, lactation, or women of childbearing potential not using highly effective contraception.
- MRI contraindications (e.g., metal implants, claustrophobia).
- Participation in other clinical trials within 3 months, involving an investigational medicinal product or enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study.
- Any other condition deemed by the investigator to compromise safety or interfere with study assessments.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Department of Endocrinology, Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Jing Wu, MD, PhD
Jing Wu, MD, PhD
- Recruiting
Department of Endocrinology, Changzhou No.2 People's Hospital
Changzhou, Jiangsu
Huijie Yang, MD
Xinhua Ye, MD, PhD
- Not yet recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Haixia Liu, MD, PhD
Haixia Liu, MD, PhD
- Recruiting
Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210000
Jindan Wu, MD, PhD, 86-025-52271000, wujindandan@sina.com
Jindan Wu, MD, PhD
- Recruiting
Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008
Yan Bi, MD, PhD, 86-25-83-105302, biyan@nju.edu.cn
Zhou Zhang, MD, PhD, 86-25-83-105302, zhangzhou@smail.nju.edu.cn
- Recruiting
Department of Endocrinology, Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu
Yueting Zhao, MD
Yueting Zhao, MD
- Recruiting
Department of Endocrinology, Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Fang Fang, MD, PhD
Fang Fang, MD,PhD
- Recruiting
Department of Endocrinology, Huadong Hospital Affiliated to Fudan University
Shanghai, 200040
Bin Lu, MD, PhD
Bin Lu, MD, PhD
About this study
Official title: Effects of Mazdutide on Cognitive Function in Patients With Type 2 Diabetes and Early-Stage Cognitive Impairment: A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Trial
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.
Read the detailed description
The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the efficacy and safety of mazdutide in 420 participants with T2D and early-stage cognitive impairment (MCI or mild dementia). Participants will be randomized 1:1 to receive once-weekly subcutaneous mazdutide or matching placebo in addition to background glucose-lowering therapy. Mazdutide will be initiated at 2.0 mg once weekly and up-titrated to 4.0 mg, with further escalation to 6.0 mg permitted according to prespecified glycemic, weight, tolerability, and safety criteria. 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. Secondary outcomes include cognitive and functional measures, structural brain MRI measures, and metabolic outcomes. 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.
Participants will generally continue their background glucose-lowering therapy during the trial. If glycemic control remains inadequate after titration to the highest tolerated study dose, additional glucose-lowering therapy may be initiated at the investigator's discretion. Permitted therapies include insulin glargine, metformin, gliclazide sustained-release, and acarbose. Study treatment may be interrupted, dose-reduced, or permanently discontinued for intolerance, adverse events, persistent glycemic instability, or other medical or safety reasons.
- Conditions
- Dementia, Mild, Mild Cognitive Impairment, Type 2 Diabetes
- Being tested
- Mazdutide, Placebo
- Keywords
- Type 2 Diabetes, Mild Dementia, Mild Cognitive Impairment, Dual GLP-1/Glucagon Receptor Agonist, Early-Stage Cognitive Impairment
- Medical subject headings
- Dementia, Lymphoma, Follicular, Cognitive Dysfunction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MazdutideDrug
Also called IBI362
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Mazdutide group | Experimental | 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. Receives: Drug: Mazdutide |
| Placebo group | Placebo comparator | Participants will receive weekly subcutaneous injections of matched placebo, in addition to their existing glucose-lowering therapy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated Alzheimer's Disease Rating Scale (iADRS) Score Change
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.
Measured: From Baseline to Week 76
Secondary outcomes (13)
Mini-Mental State Examination (MMSE) Score Change
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.
Measured: From Baseline to Week 76
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score Change
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.
Measured: From Baseline to Week 76
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score Change
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.
Measured: From Baseline to Week 76
Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Score Change
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.
Measured: From Baseline to Week 76
Change in Total Brain Volume
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.
Measured: From Baseline to Week 76
Change in Total White Matter Lesion Volume
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.
Measured: From Baseline to Week 76
Change in hippocampal volume
Change from baseline to Week 76 in hippocampal volume assessed by structural brain MRI.
Measured: From Baseline to Week 76
Change in entorhinal cortex volume
Change from baseline to Week 76 in entorhinal cortex volume assessed by structural brain MRI.
Measured: From Baseline to Week 76
Change in Body Weight
Change in body weight from baseline to weeks 76.
Measured: From Baseline to Week 76.
Change in Body Mass Index (BMI)
Change in BMI from baseline to week 76.
Measured: From Baseline to Week 76.
Change in Glycated Haemoglobin (HbA1c) Levels
Change in HbA1c levels from baseline to week 76
Measured: From Baseline to Week 76
Change in Fasting Plasma Glucose Levels
Change in fasting plasma glucose levels from baseline to week 76
Measured: From Baseline to Week 76
Change in 2-hour Postprandial Plasma Glucose Levels
Change in fasting plasma glucose levels from baseline to week 76
Measured: From Baseline to Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start27 Sep 2025
- Primary completion1 Aug 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, MildStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Yan Bi, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yan Bi, MD, PhD, Principal investigator, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083154
- Sponsor's protocol ID
- 2025-0502-01
- Status last verified
- Aug 2026
- First submitted
- 4 Jul 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Availability: De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval. Access Conditions: Data requests require a valid research proposal and signed data use agreement. Approval is contingent on compliance with applicable laws and ethical guidelines. Timing: Data will become available after study completion and primary publication for 3 years. Restrictions: Certain data types may be excluded due to privacy or regulatory requirements. Contact: Requests should be submitted to the study sponsor for consideration.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mazdutide on Cognitive Function in Patients With Type 2 Diabetes and Early-Stage Cognitive Impairment: A Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07083154
- Acronym / sponsor ID
- 2025-0502-01
- Conditions
- Dementia, Mild, Mild Cognitive Impairment, Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Mild Dementia, Mild Cognitive Impairment, Dual GLP-1/Glucagon Receptor Agonist, Early-Stage Cognitive Impairment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- 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
- Study start
- 27 Sep 2025 (actual)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The LIGHT-COG study is a 76-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the efficacy and safety of mazdutide in 420 participants with T2D and early-stage cognitive impairment (MCI or mild dementia). Participants will be randomized 1:1 to receive once-weekly subcutaneous mazdutide or matching placebo in addition to background glucose-lowering therapy. Mazdutide will be initiated at 2.0 mg once weekly and up-titrated to 4.0 mg, with further escalation to 6.0 mg permitted according to prespecified glycemic, weight, tolerability, and safety criteria. 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. Secondary outcomes include cognitive and functional measures, structural brain MRI measures, and metabolic outcomes. 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.
Participants will generally continue their background glucose-lowering therapy during the trial. If glycemic control remains inadequate after titration to the highest tolerated study dose, additional glucose-lowering therapy may be initiated at the investigator's discretion. Permitted therapies include insulin glargine, metformin, gliclazide sustained-release, and acarbose. Study treatment may be interrupted, dose-reduced, or permanently discontinued for intolerance, adverse events, persistent glycemic instability, or other medical or safety reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mazdutide group | Experimental | Drug: MazdutideParticipants 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 group | Placebo comparator | Drug: PlaceboParticipants will receive weekly subcutaneous injections of matched placebo, in addition to their existing glucose-lowering therapy. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- Stable glycemic control regimen for ≥3 months prior to screening, meeting one of the following:
- HbA1c 7.0-9.0% (inclusive) at screening.
Key exclusion criteria (23 listed)
- Known or suspected neurodegenerative disorders other than AD that are likely to be a major cause of cognitive impairment or to interfere with cognitive assessment, including but not limited to frontotemporal dementia and related syndromes, dementia with Lewy bodies, Parkinson's disease with cognitive impairment or dementia, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, and Huntington's disease;
- Current diagnosis of a poorly controlled or unstable psychiatric disorder (including but not limited to schizophrenia, bipolar disorder, major depressive disorder, generalized anxiety disorder, personality disorders, etc.), which, in the investigator's judgment, may interfere with study assessments, affect treatment compliance, or increase participant risk.
- With a Patient Health Questionnaire-9 (PHQ-9) score ≥10 at screening, or a Generalized Anxiety Disorder Scale-7 (GAD-7) score ≥10 at screening.
- Ischaemic or haemorrhagic stroke, transient ischaemic attack, or epileptic seizure within 3 months before screening; or other current or clinically significant central nervous system disorders or injuries likely to impair cognitive function or interfere with cognitive assessment, including but not limited to central nervous system infection, intracranial tumour, multiple sclerosis, metabolic encephalopathy, neurological disorders related to malnutrition, or severe traumatic brain injury;
- Acute hyperglycemic/hypoglycemic events within 1 year, including: Diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), and Hypoglycemic coma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MazdutideAlso: IBI362Mazdutide 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. | Drug | Mazdutide group |
| PlaceboMatching 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. | Drug | Placebo group |
Primary outcome
Integrated Alzheimer's Disease Rating Scale (iADRS) Score Change
Time frame: From Baseline to Week 76
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.
13 secondary outcomes
Mini-Mental State Examination (MMSE) Score Change
Time frame: From Baseline to Week 76
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score Change
Time frame: From Baseline to Week 76
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score Change
Time frame: From Baseline to Week 76
Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL) Score Change
Time frame: From Baseline to Week 76
Change in Total Brain Volume
Time frame: From Baseline to Week 76
Change in Total White Matter Lesion Volume
Time frame: From Baseline to Week 76
Change in hippocampal volume
Time frame: From Baseline to Week 76
Change in entorhinal cortex volume
Time frame: From Baseline to Week 76
Change in Body Weight
Time frame: From Baseline to Week 76.
Change in Body Mass Index (BMI)
Time frame: From Baseline to Week 76.
Change in Glycated Haemoglobin (HbA1c) Levels
Time frame: From Baseline to Week 76
Change in Fasting Plasma Glucose Levels
Time frame: From Baseline to Week 76
Change in 2-hour Postprandial Plasma Glucose Levels
Time frame: From Baseline to Week 76
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. Availability: De-identified participant data may be timely shared with qualified researchers upon request, subject to review and approval. Access Conditions: Data requests require a valid research proposal and signed data use agreement. Approval is contingent on compliance with applicable laws and ethical guidelines. Timing: Data will become available after study completion and primary publication for 3 years. Restrictions: Certain data types may be excluded due to privacy or regulatory requirements. Contact: Requests should be submitted to the study sponsor for consideration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yan Bi, MD, PhD principal investigator
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mazdutide in people with Dementia, Mild and Mild Cognitive Impairment, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Bi, MD, PhD (6-25-83-105302., biyan@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated Alzheimer's Disease Rating Scale (iADRS) Score Change (time frame: From Baseline to Week 76). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.