A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer’s Disease

2024-512295-36-00 Protocol I9X-MC-MTAE Therapeutic exploratory (Phase II) Ended

Start 6 Dec 2021 · End 22 May 2025 · Status Ended · 1 EU/EEA countries · 9 sites · Protocol I9X-MC-MTAE

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 327
Countries 1
Sites 9

Alzheimer Disease

To assess the effect of LY3372689 vs. placebo on clinical progression in participants with early symptomatic AD with demonstrated presence of moderate levels of tau pathology

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10]
Trial duration
6 Dec 2021 → 22 May 2025
Decision date (initial)
2024-11-26
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-512295-36-00
EudraCT number
2021-000170-29
ClinicalTrials.gov
NCT05063539

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Safety, Therapy, Pharmacokinetic, Efficacy, Pharmacodynamic

To assess the effect of LY3372689 vs. placebo on clinical progression in participants with early symptomatic AD with demonstrated presence of moderate levels of tau pathology

Conditions and MedDRA coding

Alzheimer Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months
  2. MMSE score of 22 to 30 (inclusive) at baseline
  3. CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5.
  4. Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria
  5. Have a study partner who will provide written informed consent to participate

Exclusion criteria 2

  1. Contraindication to MRI or PET scans
  2. Have known allergies to LY3372689, related compounds, or any components of the formulations

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change from Baseline to End Time Point in Integrated Alzheimer's Disease Rating Scale (iADRS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

N-4-FLUORO-5-2S4S-2-METHYL-4-5-METHYL-124-OXADIAZOL-3-YLMETHOXY-1-PIPERIDINYLMETHYL-2-THIAZOLYL-ACETAMIDE

PRD11376294 · Product

Active substance
N-4-FLUORO-5-2S4S-2-METHYL-4-5-METHYL-124-OXADIAZOL-3-YLMETHOXY-1-PIPERIDINYLMETHYL-2-THIAZOLYL-ACETAMIDE
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
200 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

N-4-FLUORO-5-2S4S-2-METHYL-4-5-METHYL-124-OXADIAZOL-3-YLMETHOXY-1-PIPERIDINYLMETHYL-2-THIAZOLYL-ACETAMIDE

PRD11376295 · Product

Active substance
N-4-FLUORO-5-2S4S-2-METHYL-4-5-METHYL-124-OXADIAZOL-3-YLMETHOXY-1-PIPERIDINYLMETHYL-2-THIAZOLYL-ACETAMIDE
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
200 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to match LY3372689

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Auxiliary 1

Flortaucipir

PRD10008562 · Product

Active substance
Flortaucipir (18F)
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INFUSION
Max daily dose
9.1 mCi millicurie(s)
Max total dose
18.2 mCi millicurie(s)
Max treatment duration
2 Day(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 18

OrganisationCity, countryDuties
Iqvia Biotech LLC
ORG-100008704
 Durham, United States Laboratory analysis
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Tier 1 Impact Pbc Inc.
ORG-100050163
 Covington, United States Other
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis
Syneos Health Inc.
ORG-100008382
 Morrisville, United States Code 11
Invicro Konica Minolta, Inc. (Parent company Molecular NeuroImaging, LLC)
ORL-000009805
 London, United Kingdom Laboratory analysis
Bioclinica Inc.
ORG-100033079
 Philadelphia, United States Laboratory analysis
Cogstate Inc.
ORG-100045256
 New Haven, United States Other, Data management
Q Squared Solutions LLC
ORG-100043195
 Durham, United States Laboratory analysis
Iqvia Biotech LLC
ORG-100008704
 Durham, United States On site monitoring
Clinical Ink
ORL-000003414
 Horsham, United States Data management
Linus Health Inc.
ORG-100042376
 Boston, United States Laboratory analysis
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Trendyminds LLC
ORG-100045580
 Indianapolis, United States Other
Teckro Limited
ORG-100041454
 Limerick, Ireland Other
Reify Health Inc.
ORG-100049669
 Boston, United States Other
Research Square R&D LLC
ORL-000009807
 Durham, United States Other
Simpleshow USA Corp.
ORG-100044593
 Miami, United States Other

Locations

1 EU/EEA country · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
Poland Ended 55 9
Rest of world
Japan, United States, Australia, Canada
 — 272 —

Investigational sites

Poland

9 sites · Ended
Centrum Medyczne Neuro Protect
NA, ul. Klaudyny 16C, 01-684, Warszawa
Centrum Medyczne Neuromed Sp. z o.o.
NA, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Podlaskie Centrum Psychogeriatrii
NA, ul. Swobodna 38 lok 9, 15-756, Białystok
NZOZ Neuro-Kard "Ilkowski i Partnerzy" Spółka Partnerska Lekarzy
NA, ul. Wierzbowa 2/2, 61-853, Poznań
Centrum Medyczne Senior
NA, Ul. Rzemieslnicza 3, 81-855, Sopot
Centrum Badań Klinicznych PI-House
NA, ul. Na Zaspę 3, 80-546, Gdansk
Euromedis Sp. z o.o.
NA, Ul. Powstancow Wielkopolskich 33 A, 70-111, Szczecin
Diamond Clinic Sp. z o.o.
NA, Ul. Stefana Rogozinskiego 6/U3, 31-559, Cracow
Wrocławskie Centrum Alzheimerowskie
NA, ul. Stefana Rogozińskiego 6/U3, local 7h, Wroclaw

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Poland 2021-12-06 2025-03-31 2022-03-14 2022-08-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
I9X-MC-MTAE Final Summary of results
SUM-134620
 2026-05-20T07:47:30 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
I9X-MC-MTAE Lay person summary of results 2026-05-19T10:03:23 Submitted Laypersons Summary of Results

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) LY3372689 MTAE Plain Language Summary 1
Protocol (for publication) D1_Protocol 2024-512295-36-00_Redacted e
Protocol (for publication) D4_Patient facing documents copyright statement 1
Recruitment arrangements (for publication) K1_Recruitment arrangements statement 1
Subject information and informed consent form (for publication) L1_SIS and ICF _AS_1 1
Subject information and informed consent form (for publication) L1_SIS and ICF _Extension_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF _partner 1
Subject information and informed consent form (for publication) L1_SIS and ICF _PET_MRI_substudy 1
Subject information and informed consent form (for publication) L1_SIS and ICF _SC_2_Redacted N/A
Subject information and informed consent form (for publication) L1_SIS and ICF for partner_Extension_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Add for partner 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Greenphire_Redacted 2.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_NoGreenphire_Redacted 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening 1
Subject information and informed consent form (for publication) L1_SIS and ICF_SoC_Redacted 1
Summary of results (for publication) LY3372689 MTAE EUCTIS Final Results Record 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-15 Poland Acceptable
2024-11-22
 2024-11-26

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