A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

What this trial studies

TRAILRUNNER-ALZ 1 is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of remternetug in participants with early symptomatic AD. Initially, 600 participants will enroll in the double-blind treatment period. Participants in the double-blind treatment period will receive remternetug or placebo administered via subcutaneous injection or intravenous infusion. Following the 52-week main study period, participants will continue participation for up to an additional 76 weeks in an extension period. Participants who previously received remternetug will receive placebo and participants who previously received placebo will receive remternetug. Thus, all participants will receive remternetug if they complete the study. An additional 974 participants with early Alzheimer's disease will be enrolled to an addendum safety cohort. The participants will be administered open label remternetug via subcutaneous injection or intravenous infusion. Participants enrolled into the addendum safety cohort are not eligible for the extension period.

Who can join: the full rules

Inclusion Criteria:

* Gradual and progressive change in cognitive function ≥6 months prior to screening.
* A Mini-Mental (MMSE) score of 20 to 30 (inclusive) at screening.
* Has an amyloid PET scan result consistent with the eligibility criteria.
* Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.
* Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening.
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
* Males and females will be eligible for this study.
* Women not of childbearing potential (WNOCBP) may participate in this trial.

Exclusion Criteria:

* Current serious or unstable illnesses that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of \<24 months.
* History of cancer with high risk of recurrence and preventing completion of the trial.
* Participants with any current primary psychiatric diagnosis other than AD that in the investigator's opinion, is likely to confound interpretation of the drug effect, affect cognitive assessment, or affect the participant's ability to complete the study.
* History of clinically significant multiple or severe drug allergies.
* Have any clinically important abnormality at screening, as determined by investigator that could be detrimental to the participant, could compromise the study, or show evidence of other etiologies for dementia.
* Screening magnetic resonance imaging (MRI) which shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study.
* Have any contraindications for MRI or positron emission tomography (PET).
* Have had prior treatment with a passive anti-amyloid immunotherapy.
* Have received active immunization against Aβ in any other study.
* Have known allergies to remternetug related compounds, or any components of the formulation.

Where it's running

• MD First Research - Chandler
  Chandler, Arizona, United States
• Hope Clinical Research, Inc.
  Canoga Park, California, United States
• North County Neurology Associates
  Carlsbad, California, United States
• Wr- Pri, Llc
  Encino, California, United States
• Neuro-Pain Medical Center
  Fresno, California, United States
• Irvine Clinical Research
  Irvine, California, United States

+26 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) — Eli Lilly and Company

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

• Abemaciclib in healthy adults: comparing tablet and granule forms to see how they enter the bloodstream

  This study tests different oral forms of abemaciclib in healthy volunteers to see how much and how fast the drug gets into the blood and what side effects occur.

  Recruiting Phase 1 Eli Lilly and Company · Singapore · NCT07818967

• Weekly tirzepatide vs placebo for pediatric obesity (6 to <12 years)

  This study tests whether weekly tirzepatide can help children aged 6 to under 12 with obesity, in addition to healthy lifestyle guidance.

  Recruiting at 2 sites Phase 3 Eli Lilly and Company · Tucson, Arizona and 81 other locations · NCT07817875

• Testing LY4329090 in adults with overweight or obesity who are otherwise healthy

  This study tests how LY4329090 works in adults with overweight or obesity who are otherwise healthy to see if it is tolerated and what side effects might occur.

  Recruiting at 2 sites Phase 1 Eli Lilly and Company · Daytona Beach, Florida and 2 other locations · NCT07808073

• Eloralintide and birth-control pill study in women with overweight or obesity

  This study tests whether eloralintide affects how oral contraceptives work in women with overweight or obesity.

  Recruiting at 2 sites Phase 1 Eli Lilly and Company · Daytona Beach, Florida and 1 other locations · NCT07808060

• Tirzepatide for type 1 diabetes patients who are overweight or obese

  This study tests whether tirzepatide can affect stomach emptying in adults with type 1 diabetes and overweight or obesity.

  Recruiting Phase 1 Eli Lilly and Company · Miami, Florida · NCT07803744

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.