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Could a diabetes drug also protect the brain? new trial aims to find out

NCT ID NCT07083154

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This 76-week study tests whether mazdutide, a weekly injection already used for diabetes, can slow memory and thinking decline in 420 adults aged 50-75 with type 2 diabetes and early dementia. Half receive the drug, half a placebo. Researchers will measure changes in thinking skills and daily function over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mazdutide (a weekly injection that targets two gut hormones to control blood sugar and possibly protect the brain)
What this could lead to
If it works, this could point toward a new treatment that slows memory loss and thinking problems in people with type 2 diabetes and early dementia.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not improve cognition, and side effects like nausea or digestive issues are possible. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of type 2 diabetes according to the American Diabetes Association criteria; 2. Aged 50-75 years (inclusive), male or female. 3. Early-stage cognitive impairment (defined as mild cognitive impairment or mild dementia), with all of the following: 1. MMSE score \>20 and \<27, 2. CDR global score 0.5-1.0 (inclusive), with a CDR memory subscore ≥0.5, 3. A history of gradual and progressive cognitive decline for at least 6 months, reported by the participant or an informant. 4. Stable glycemic control regimen for ≥3 months prior to screening, meeting one of the following: 1. Lifestyle/dietary intervention alone (no glucose-lowering drugs), 2. Oral antidiabetic drugs (OADs), with or without once-daily basal insulin. 5. HbA1c 7.0-9.0% (inclusive) at screening. 6. BMI ≥20 kg/m², with stable weight (fluctuation \<5%) for ≥3 months. 7. 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: 1. No treatment: Not receiving any pharmacological or non-pharmacological interventions for cognitive impairment; 2. Non-pharmacological therapy only: Engaged exclusively in non-drug interventions (e.g., cognitive training); 3. Pharmacological therapy: Using approved symptomatic cognitive-enhancing medications (e.g., cholinesterase inhibitors, NMDA receptor antagonists), excluding disease-modifying therapies for Alzheimer's disease (AD). 8. Ability to comply with systematic cognitive and functional assessments. 9. Fully understands the trial protocol, voluntarily signs the informed consent form (ICF), and agrees to adhere to all study requirements and restrictions. Exclusion Criteria: 1. 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; 2. 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. 3. 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. 4. 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; 5. Acute hyperglycemic/hypoglycemic events within 1 year, including: Diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), and Hypoglycemic coma 6. 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; 7. 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. 8. 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). 9. Medical history of: 1. Medullary thyroid carcinoma (MTC), pancreatitis 2. Multiple endocrine neoplasia type 2 (MEN2) 3. Gallbladder/biliary disease, severe gastrointestinal disorders, or bowel resection 4. Active malignancy 10. Uncontrolled or potentially unstable diabetic retinopathy/maculopathy. 11. Severe organ dysfunction, including: 1. ALT/AST \>3× upper limit of normal (ULN); 2. eGFR \<45 mL/min/1.73m² (CKD-EPI equation); 3. History of unstable angina or myocardial infarction within 3 months before screening, or current heart failure of NYHA class II or higher. 12. Known/suspected hypersensitivity to the investigational product or related compounds 13. Pregnancy, lactation, or women of childbearing potential not using highly effective contraception. 14. MRI contraindications (e.g., metal implants, claustrophobia). 15. 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. 16. Any other condition deemed by the investigator to compromise safety or interfere with study assessments.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Endocrinology, Changzhou No.2 People's Hospital

    RECRUITING

    Changzhou, Jiangsu, China

  • Department of Endocrinology, Endocrine and Metabolic Disease Medical Center,Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Department of Endocrinology, Huadong Hospital Affiliated to Fudan University

    RECRUITING

    Shanghai, 200040, China

  • Department of Endocrinology, Jiangsu Province Hospital of Traditional Chinese Medicine

    RECRUITING

    Nanjing, Jiangsu, China

  • Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Department of Endocrinology, Shanghai General Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200080, China

  • Department of Endocrinology, Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, 410008, China

  • The Second Affiliated Hospital of Dalian Medical University

    NOT_YET_RECRUITING

    Dalian, Liaoning, China

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