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RecruitingNCT07219953RENEW-ALC-2Updated Nov 4, 2026

A Study of Brenipatide in Participants With Alcohol Use Disorder

A Phase 3 interventional study of LY3537031 and Placebo in Alcohol Use Disorder, sponsored by Eli Lilly and Company. Recruiting at 115 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Updated Nov 4, 2026Site recruiting status changed1 site removedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
1,100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to see if brenipatide when compared to a placebo works and is safe for participants with Alcohol Use Disorder (AUD) and hazardous alcohol use. Participation in this study will last approximately 56 weeks.

02

Conditions studied

  • Alcohol Use Disorder

Browse trials for

03

In context

Alcoholism

1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

This study's planned enrollment of 1,100 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Browse Eli Lilly and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must be a minimum of 20 years of age for the investigative sites in Japan.
  • Are seeking treatment and are motivated to stop or cut down on drinking.

  • Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as

    • self-inject study intervention Note: Participants who are not able to perform the injections must receive assistance from a support person trained to administer the study intervention.
    • store and use the provided blinded study intervention, as directed
    • maintain electronic and paper study diaries, as applicable, and
    • complete the required questionnaires.

Exclusion criteria

Exclusion Criteria:

  • Have evidence of current or within the past 180 days prior to screening (V1), history of any substance use disorder(s) of any severity with a pattern of persistent illicit or nonprescribed substance use as indicated by clinical interview, except alcohol, nicotine, or caffeine.
  • Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past 6 months, or Have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months

  • Have either of the following:

    • history of advanced liver disease, including advanced liver fibrosis [Stage 3] or cirrhosis [Stage 4], based on prior biomarkers, imaging or liver , OR
    • history of acute or alcohol-associated hepatitis based on prior liver biopsy.
  • Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening (V1).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,100 participants (estimated)

Study arms

  • Experimental
    LY3537031 Period 1

    Escalating doses administered subcutaneously (SC)

    Drug: LY3537031 · Drug: Placebo

  • Experimental
    LY3537031 Period 2

    Administered SC

    Drug: LY3537031 · Drug: Placebo

  • Placebo comparator
    Placebo

    Administered SC

    Drug: Placebo

Interventions

  • DrugLY3537031

    Administered SC

    Also known as: Brenipatide

  • DrugPlacebo

    Administered SC

06

What researchers measure

Primary outcomes

  1. Change in Drinking Patterns in Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (TLFB)

    Time frame: Up to 56 weeks

Secondary outcomes

  1. Change in Daily Alcohol Consumption as Assessed by the TLFB

    Time frame: Up to 56 weeks

  2. Mean Change in Alcohol Craving as Assessed by the Penn Alcohol Craving Scale (PACS)

    Time frame: Baseline up to Week 56

  3. Mean Change in Alcohol Use Disorders Identification Test (AUDIT) Score

    Time frame: Baseline up to Week 56

  4. Mean Change in Body Weight

    Time frame: Baseline up to Week 56

  5. Mean Change in Patient Reported Health Outcomes as Measured by Short Form 36, v2 (SF-36) Acute Form Domain and Component Summary Scores

    Time frame: Baseline up to Week 56

  6. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

    Time frame: Baseline up to Week 56

  7. Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA)

    Time frame: Baseline up to Week 56

07

Study locations

54 of 115 sites recruiting
  • Headlands Research - Scottsdale
    Scottsdale, Arizona 85260, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Woodland International Research Group
    Little Rock, Arkansas 72211, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • UCLA Clinical & Translational Research Center (CTRC)
    Los Angeles, California 90095, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Artemis Institute for Clinical Research
    Riverside, California 92503, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Artemis Institute for Clinical Research
    San Diego, California 92123, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
    San Francisco, California 94158, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Accel Research Sites - Lakeland Clinical Research Unit
    Lakeland, Florida 33803, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Innovative Clinical Research
    Lauderhill, Florida 33319, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • K2 Medical Research - Maitland
    Maitland, Florida 32751, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • K2 Medical Research ORLANDO
    Maitland, Florida 32751, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Life Arc Research Centers - Miami
    Miami, Florida 33126, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Wellness Research Center
    Miami, Florida 33135, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Life Medical Research Group Corp
    Miami Gardens, Florida 33014, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Charter Research - Orlando
    Orlando, Florida 32803, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • K2 Medical Research - Tampa
    Tampa, Florida 33634, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Re:Cognition Health - Chicago
    Chicago, Illinois 60611, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Maryland Treatment Centers - Mountain Manor Treatment Center
    Baltimore, Maryland 21229, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Maryland Treatment Centers - Avery Road Treatment Center
    Rockville, Maryland 20853, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Adams Clinical Boston
    Boston, Massachusetts 02116, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • K2 Medical Research - Foxborough
    Foxborough, Massachusetts 02035, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Adams Clinical Bronx
    The Bronx, New York 10461, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Penn Medicine: University of Pennsylvania Health System
    Philadelphia, Pennsylvania 19104, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Brown University School of Public Health
    Providence, Rhode Island 02903, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Avera Research Institute - Sioux Falls
    Sioux Falls, South Dakota 57108, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Modern Research Associates, PLLC
    Dallas, Texas 75231, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Adams Clinical Dallas
    DeSoto, Texas 75115, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Biopharma Informatic, LLC
    Houston, Texas 77043, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Re:Cognition Health
    Fairfax, Virginia 22031, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • ANIMA Research
    Diepenbeek, 3590, Belgium
    Recruiting
    • · Contact003211316272
    • Erik Buntinx · Principal investigator
  • Kormont
    Kluisbergen, 9690, Belgium
    Recruiting
    • · Contact32 496 376259
    • Klaas Vercruysse · Principal investigator
  • Gezondheidshuis De Gloed
    Machelen, 9870, Belgium
    Recruiting
    • · Contact32 496 376259
    • Klaas Vercruysse · Principal investigator
  • Meclinas
    Mechelen, 2800, Belgium
    Recruiting
    • · Contact003215792797
    • Claudia Cornelis · Principal investigator
  • Medisch Centrum Saffrou
    Oudenaarde, 9636, Belgium
    Recruiting
    • · Contact32 496 376259
    • Klaas Vercruysse · Principal investigator
  • Beijing Anding Hospital - Affiliated Capital University of Medical Science
    Beijing, 100088, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Beijing HuiLongGuan Hospital
    Beijing, 100096, China
    Recruiting
    • Yunlong Tan · Principal investigator
  • The Second People's Hospital of Hunan Province
    Changsha, 410007, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Second Xiangya Hospital of Central South University
    Changsha, 410011, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • West China Hospital, Sichuan University
    Cheng Du Shi, 610041, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Fourth People's Hospital of Chengdu
    Chengdu, 610036, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Guangzhou Brain Hospital
    Guangzhou, 510370, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Seventh People's Hospital of Hangzhou
    Hangzhou, 310000, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Zhejiang Provincial People's Hospital
    Hangzhou, 310014, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
    Hangzhou, 310016, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Fourth Hospital of Harbin Medical University
    Harbin, 150001, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hefei No.4 People's Hospital
    Hefei, 230061, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Huzhou Third Municipal Hospital
    Huzhou, 313000, China
    Completed

    Not enrolling at this site — choose another above.

  • Shandong Mental Health Center
    Jinan, 250012, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • First Affiliated Hospital of Kunming Medical University
    Kunming, 650032, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Affilicated Kangning Hospital of Ningbo University
    Ningbo, 315201, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Shanghai Mental Health Center
    Shanghai, 200030, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Shenzhen Kangning Hospital
    Shenzhen, 518003, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The First Hospital of Hebei Medical University
    Shijiazhuang, 050031, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Affiliated hospital of Southwest Medical University
    Sichuan, 646000, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Wuhu Hospital of Beijing Anding hospital
    Wuhu, 242407, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Xi An Mental Health Center
    Xi'an, 710061, China
    Recruiting
    • Guibin Li · Principal investigator
  • Xiamen Xianyue Hospital
    Xiamen, 361012, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Xianyang Hospital of Yan'an University
    Xianyang, 712000, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Psychiatric Hospital of Henan Province
    Xinxiang, 453003, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Zhenjiang Mental Health Center
    Zhenjiang, 212000, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Zhumadian Psychiatric Hospital
    Zhumadian, 463000, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • FutureMeds Berlin
    Berlin, 10629, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Velocity Clinical Research, Berlin
    Berlin, 10787, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Klinische Forschung Dresden
    Dresden, 01069, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Klinische Forschung Hamburg
    Hamburg, 20253, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Zentralinstitut für Seelische Gesundheit
    Mannheim, 68159, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • FutureMeds Offenbach
    Offenbach, 63065, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Klinische forschung Schwerin GmbH
    Schwerin, 19055, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Tokyo-Eki Center-building Clinic
    Chūōku, 103-0027, Japan
    Recruiting
    • · Contact81120023812
    • Arihiro Kiyosue · Principal investigator
  • Ai Sakura Clinic
    Fukuoka, 810-0001, Japan
    Recruiting
    • · Contact81120023812
    • Masamiki Kimura · Principal investigator
  • Hiro Mental Clinic
    Fukuoka, 810-0004, Japan
    Recruiting
    • · Contact81120023812
    • Hiroaki Furui · Principal investigator
  • Rainbow and Sea Hospital
    Karatsu, 847-0031, Japan
    Recruiting
    • · Contact81120023812
    • Taro Shindo · Principal investigator
  • Tatsuta Clinic
    Kobe, 651-0097, Japan
    Recruiting
    • · Contact81120023812
    • Kenji Tatsuta · Principal investigator
  • Arata Clinic
    Nagasaki, 852-8137, Japan
    Recruiting
    • · Contact81120023812
    • Takatoshi Mori · Principal investigator
  • Noguchi Naika Clinic
    Nakano, 165-0031, Japan
    Recruiting
    • · Contact81120023812
    • Yoshimasa Noguchi · Principal investigator
  • Yokogawa Ekimae Clinic
    Nishi, 733-0011, Japan
    Recruiting
    • · Contact81120023812
    • Ariyuki Kagaya · Principal investigator
  • Hillside Clinic Jingumae
    Shibuya City, 150-0001, Japan
    Recruiting
    • · Contact81120023812
    • Masayoshi SONE · Principal investigator
  • Samoncho Clinic
    Shinjuku, 160-0017, Japan
    Recruiting
    • · Contact81120023812
    • Takahiro Yokoyama · Principal investigator
  • Keiai Clinic
    Shinjuku-ku, 160-0004, Japan
    Recruiting
    • · Contact81120023812
    • Yoshinori Horie · Principal investigator
  • Higashi Shinjuku Clinic
    Shinjuku-ku, 169-0072, Japan
    Recruiting
    • · Contact81120023812
    • Hiroaki Kondo · Principal investigator
  • Sakurazaka Clinic SophyAnce
    Tokyo, 106-0032, Japan
    Recruiting
    • · Contact81120023812
    • Haruhito Muto · Principal investigator
  • Tsukuba University Hospital
    Tsukuba, 305-8576, Japan
    Recruiting
    • · Contact81120023812
    • Hisashi Yoshimoto · Principal investigator
  • Maekawa Medical Clinic
    Yokohama, 220-0004, Japan
    Recruiting
    • · Contact81120023812
    • Hiromitsu Maekawa · Principal investigator
  • National Hospital Organization Hizen Psychiatric Medical Center
    Yoshinogari-cho, Kanzaki-gun, 842-0192, Japan
    Recruiting
    • · Contact81120023812
    • Kazunori Matsuguchi · Principal investigator
  • Hallym University Sacred Heart Hospital
    Anyang-si, 14068, South Korea
    Recruiting
    • Kyung Hee Park · Principal investigator
  • Pusan National University Yangsan Hospital
    Busan, 50612, South Korea
    Recruiting
    • · Contact82-55-360-2860
    • Sang Yeoup Lee · Principal investigator
  • Chungbuk National University Hospital
    Cheongju-si, 28644, South Korea
    Recruiting
    • Joon Hyung Jung · Principal investigator
  • Hanyang University Guri Hospital
    Guri-si, 11923, South Korea
    Recruiting
    • Sangmo Hong · Principal investigator
  • Inha University Hospital
    Incheon, 22332, South Korea
    Recruiting
    • Yangsik Kim · Principal investigator
  • Kyungpook National University Hospital
    Junggu, 41944, South Korea
    Recruiting
    • Hae-Jin Ko · Principal investigator
  • Gachon University Gil Medical Center
    Namdong-gu, 21565, South Korea
    Recruiting
    • · Contact+82-32-458-2778
    • Kyoung-Kon Kim · Principal investigator
  • Konyang University Hospital
    Seogu, 35365, South Korea
    Recruiting
    • Jee Hyun Kang · Principal investigator
  • Konyang University Hospital
    Seogu, 35365, South Korea
    Recruiting
    • Hong Seok Oh · Principal investigator
  • Seoul National University Bundang Hospital
    Seongnam, 13620, South Korea
    Recruiting
    • Kiheon Lee · Principal investigator
  • Seoul National University Hospital
    Seoul, 03080, South Korea
    Recruiting
    • BeLong Cho · Principal investigator
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, South Korea
    Recruiting
    • Byung Wan Lee · Principal investigator
  • Hanyang University Seoul Hospital
    Seoul, 04763, South Korea
    Recruiting
    • Sungwon Roh · Principal investigator
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital
    Seoul, 06591, South Korea
    Recruiting
    • Daijin Kim · Principal investigator
  • The Catholic University of Korea, Uijeongbu St. Mary's Hospital
    Uijeongbu-si, 11765, South Korea
    Recruiting
    • Hae Kook Lee · Principal investigator
  • Changhua Christian Hospital
    Changhua County, 50006, Taiwan
    Recruiting
    • Hsu Wen-Yu · Principal investigator
  • Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
    Hualien City, 970, Taiwan
    Recruiting
    • Shao-Tsu Chen · Principal investigator

Showing the first 100 of 115 sites across 8 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

Data sharing details ↗ · vivli.org

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Apr 2028, 30 months after the start.

Of 25 phase 3 interventional studies under Alcoholism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's planned 30 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2025
First posted
Oct 22, 2025
StartActual
Oct 16, 2025
Primary completionEst.
Apr 2028
CompletionEst.
Apr 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site removed. 61 sites changed recruiting status (60 now active, not recruiting, 1 now completed)
Show 61 sites
  • Headlands Research - Scottsdale · Scottsdale, United StatesRecruiting→Active, not recruiting
  • Woodland International Research Group · Little Rock, United StatesRecruiting→Active, not recruiting
  • UCLA Clinical & Translational Research Center (CTRC) · Los Angeles, United StatesRecruiting→Active, not recruiting
  • Artemis Institute for Clinical Research · Riverside, United StatesRecruiting→Active, not recruiting
  • Artemis Institute for Clinical Research · San Diego, United StatesRecruiting→Active, not recruiting
  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay · San Francisco, United StatesRecruiting→Active, not recruiting
  • Accel Research Sites - Lakeland Clinical Research Unit · Lakeland, United StatesRecruiting→Active, not recruiting
  • Innovative Clinical Research · Lauderhill, United StatesRecruiting→Active, not recruiting
  • K2 Medical Research - Maitland · Maitland, United StatesRecruiting→Active, not recruiting
  • K2 Medical Research ORLANDO · Maitland, United StatesRecruiting→Active, not recruiting
  • Life Arc Research Centers - Miami · Miami, United StatesRecruiting→Active, not recruiting
  • Wellness Research Center · Miami, United StatesRecruiting→Active, not recruiting
  • Life Medical Research Group Corp · Miami Gardens, United StatesRecruiting→Active, not recruiting
  • Charter Research - Orlando · Orlando, United StatesRecruiting→Active, not recruiting
  • K2 Medical Research - Tampa · Tampa, United StatesRecruiting→Active, not recruiting
  • Re:Cognition Health - Chicago · Chicago, United StatesRecruiting→Active, not recruiting
  • Maryland Treatment Centers - Mountain Manor Treatment Center · Baltimore, United StatesRecruiting→Active, not recruiting
  • Maryland Treatment Centers - Avery Road Treatment Center · Rockville, United StatesRecruiting→Active, not recruiting
  • Adams Clinical Boston · Boston, United StatesRecruiting→Active, not recruiting
  • K2 Medical Research - Foxborough · Foxborough, United StatesRecruiting→Active, not recruiting
  • Adams Clinical Bronx · The Bronx, United StatesRecruiting→Active, not recruiting
  • Penn Medicine: University of Pennsylvania Health System · Philadelphia, United StatesRecruiting→Active, not recruiting
  • Brown University School of Public Health · Providence, United StatesRecruiting→Active, not recruiting
  • Avera Research Institute - Sioux Falls · Sioux Falls, United StatesRecruiting→Active, not recruiting
  • Modern Research Associates, PLLC · Dallas, United StatesRecruiting→Active, not recruiting
  • Adams Clinical Dallas · DeSoto, United StatesRecruiting→Active, not recruiting
  • Biopharma Informatic, LLC · Houston, United StatesRecruiting→Active, not recruiting
  • Re:Cognition Health · Fairfax, United StatesRecruiting→Active, not recruiting
  • Chang Gung Medical Foundation-Linkou Branch · Taoyuan, TaiwanRecruiting→Active, not recruiting
  • Beijing Anding Hospital - Affiliated Capital University of Medical Science · Beijing, ChinaRecruiting→Active, not recruiting
  • …and 31 more on the registry record
Show 1 removed
  • North Star Medical Research · Middleburg Heights, United States
across 2 updates, Oct 8, 2026 – Nov 4, 2026
Site contacts
Changed at 62 sites. See the sites
Show 62 sites
  • Headlands Research - Scottsdale · Scottsdale, United StatesContact removed (no phone or email listed)
  • Woodland International Research Group · Little Rock, United StatesContact removed •••8681Contact removed (no phone or email listed)
  • UCLA Clinical & Translational Research Center (CTRC) · Los Angeles, United StatesContact removed •••5383Contact removed (no phone or email listed)
  • Artemis Institute for Clinical Research · Riverside, United StatesContact removed •••1190Contact removed (no phone or email listed)
  • Artemis Institute for Clinical Research · San Diego, United StatesContact removed •••3647Contact removed (no phone or email listed)
  • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay · San Francisco, United StatesContact removed (no phone or email listed)
  • Accel Research Sites - Lakeland Clinical Research Unit · Lakeland, United StatesContact removed •••2087Contact removed (no phone or email listed)
  • Innovative Clinical Research · Lauderhill, United StatesContact removed •••1971Contact removed (no phone or email listed)
  • K2 Medical Research - Maitland · Maitland, United StatesContact removed (no phone or email listed)
  • K2 Medical Research ORLANDO · Maitland, United StatesContact removed •••5252Contact removed (no phone or email listed)
  • Life Arc Research Centers - Miami · Miami, United StatesContact removed (no phone or email listed)
  • Wellness Research Center · Miami, United StatesContact removed •••2623Contact removed (no phone or email listed)
  • Life Medical Research Group Corp · Miami Gardens, United StatesContact removed •••4111Contact removed (no phone or email listed)
  • Charter Research - Orlando · Orlando, United StatesContact removed (no phone or email listed)
  • K2 Medical Research - Tampa · Tampa, United StatesContact removed •••5252Contact removed (no phone or email listed)
  • Re:Cognition Health - Chicago · Chicago, United StatesContact removed (no phone or email listed)
  • Maryland Treatment Centers - Mountain Manor Treatment Center · Baltimore, United StatesContact removed (no phone or email listed)
  • Maryland Treatment Centers - Avery Road Treatment Center · Rockville, United StatesContact removed (no phone or email listed)
  • Adams Clinical Boston · Boston, United StatesContact removed (no phone or email listed)
  • K2 Medical Research - Foxborough · Foxborough, United StatesContact removed •••8950Contact removed (no phone or email listed)
  • Adams Clinical Bronx · The Bronx, United StatesContact removed (no phone or email listed)
  • Penn Medicine: University of Pennsylvania Health System · Philadelphia, United StatesContact removed •••1943Contact removed (no phone or email listed)
  • Brown University School of Public Health · Providence, United StatesContact removed (no phone or email listed)
  • Avera Research Institute - Sioux Falls · Sioux Falls, United StatesContact removed •••3154Contact removed (no phone or email listed)
  • Modern Research Associates, PLLC · Dallas, United StatesContact removed (no phone or email listed)
  • Adams Clinical Dallas · DeSoto, United StatesContact removed (no phone or email listed)
  • Biopharma Informatic, LLC · Houston, United StatesContact removed •••3610Contact removed (no phone or email listed)
  • Re:Cognition Health · Fairfax, United StatesContact removed (no phone or email listed)
  • Chang Gung Medical Foundation-Linkou Branch · Taoyuan, TaiwanContact removed (no phone or email listed)
  • Beijing Anding Hospital - Affiliated Capital University of Medical Science · Beijing, ChinaContact removed (no phone or email listed)
  • …and 32 more sites
across 2 updates, Oct 8, 2026 – Nov 4, 2026
Show all 2 updates
  1. Nov 4, 2026
    1 site removed. 32 sites changed recruiting status (31 now active, not recruiting, 1 now completed)
    Show 32 sites
    • Beijing Anding Hospital - Affiliated Capital University of Medical Science · Beijing, ChinaRecruiting→Active, not recruiting
    • The Second People's Hospital of Hunan Province · Changsha, ChinaRecruiting→Active, not recruiting
    • The Second Xiangya Hospital of Central South University · Changsha, ChinaRecruiting→Active, not recruiting
    • West China Hospital, Sichuan University · Cheng Du Shi, ChinaRecruiting→Active, not recruiting
    • The Fourth People's Hospital of Chengdu · Chengdu, ChinaRecruiting→Active, not recruiting
    • Guangzhou Brain Hospital · Guangzhou, ChinaRecruiting→Active, not recruiting
    • The Seventh People's Hospital of Hangzhou · Hangzhou, ChinaRecruiting→Active, not recruiting
    • Zhejiang Provincial People's Hospital · Hangzhou, ChinaRecruiting→Active, not recruiting
    • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine · Hangzhou, ChinaRecruiting→Active, not recruiting
    • The Fourth Hospital of Harbin Medical University · Harbin, ChinaRecruiting→Active, not recruiting
    • Hefei No.4 People's Hospital · Hefei, ChinaRecruiting→Active, not recruiting
    • Huzhou Third Municipal Hospital · Huzhou, ChinaRecruiting→Completed
    • Shandong Mental Health Center · Jinan, ChinaRecruiting→Active, not recruiting
    • First Affiliated Hospital of Kunming Medical University · Kunming, ChinaRecruiting→Active, not recruiting
    • The Affilicated Kangning Hospital of Ningbo University · Ningbo, ChinaRecruiting→Active, not recruiting
    • Shanghai Mental Health Center · Shanghai, ChinaRecruiting→Active, not recruiting
    • Shenzhen Kangning Hospital · Shenzhen, ChinaRecruiting→Active, not recruiting
    • The First Hospital of Hebei Medical University · Shijiazhuang, ChinaRecruiting→Active, not recruiting
    • The Affiliated hospital of Southwest Medical University · Sichuan, ChinaRecruiting→Active, not recruiting
    • Wuhu Hospital of Beijing Anding hospital · Wuhu, ChinaRecruiting→Active, not recruiting
    • Xiamen Xianyue Hospital · Xiamen, ChinaRecruiting→Active, not recruiting
    • Xianyang Hospital of Yan'an University · Xianyang, ChinaRecruiting→Active, not recruiting
    • Psychiatric Hospital of Henan Province · Xinxiang, ChinaRecruiting→Active, not recruiting
    • Zhenjiang Mental Health Center · Zhenjiang, ChinaRecruiting→Active, not recruiting
    • Zhumadian Psychiatric Hospital · Zhumadian, ChinaRecruiting→Active, not recruiting
    • FutureMeds Berlin · Berlin, GermanyRecruiting→Active, not recruiting
    • Velocity Clinical Research, Berlin · Berlin, GermanyRecruiting→Active, not recruiting
    • Klinische Forschung Dresden · Dresden, GermanyRecruiting→Active, not recruiting
    • Klinische Forschung Hamburg · Hamburg, GermanyRecruiting→Active, not recruiting
    • Zentralinstitut für Seelische Gesundheit · Mannheim, GermanyRecruiting→Active, not recruiting
    • …and 2 more on the registry record
    Show 1 removed
    • North Star Medical Research · Middleburg Heights, United States
    Site contacts Changed at 33 sites. See the sites
    Show 33 sites
    • Beijing Anding Hospital - Affiliated Capital University of Medical Science · Beijing, ChinaContact removed (no phone or email listed)
    • The Second People's Hospital of Hunan Province · Changsha, ChinaContact removed (no phone or email listed)
    • The Second Xiangya Hospital of Central South University · Changsha, ChinaContact removed (no phone or email listed)
    • West China Hospital, Sichuan University · Cheng Du Shi, ChinaContact removed •••1715Contact removed (no phone or email listed)
    • The Fourth People's Hospital of Chengdu · Chengdu, ChinaContact removed •••9130Contact removed (no phone or email listed)
    • Guangzhou Brain Hospital · Guangzhou, ChinaContact removed (no phone or email listed)
    • The Seventh People's Hospital of Hangzhou · Hangzhou, ChinaContact removed •••7129Contact removed (no phone or email listed)
    • Zhejiang Provincial People's Hospital · Hangzhou, ChinaContact removed (no phone or email listed)
    • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine · Hangzhou, ChinaContact removed (no phone or email listed)
    • The Fourth Hospital of Harbin Medical University · Harbin, ChinaContact removed (no phone or email listed)
    • Hefei No.4 People's Hospital · Hefei, ChinaContact removed (no phone or email listed)
    • Huzhou Third Municipal Hospital · Huzhou, ChinaContact removed (no phone or email listed)
    • Shandong Mental Health Center · Jinan, ChinaContact removed (no phone or email listed)
    • First Affiliated Hospital of Kunming Medical University · Kunming, ChinaContact removed (no phone or email listed)
    • The Affilicated Kangning Hospital of Ningbo University · Ningbo, ChinaContact removed (no phone or email listed)
    • Shanghai Mental Health Center · Shanghai, ChinaContact removed (no phone or email listed)
    • Shenzhen Kangning Hospital · Shenzhen, ChinaContact removed (no phone or email listed)
    • The First Hospital of Hebei Medical University · Shijiazhuang, ChinaContact removed (no phone or email listed)
    • The Affiliated hospital of Southwest Medical University · Sichuan, ChinaContact removed (no phone or email listed)
    • Wuhu Hospital of Beijing Anding hospital · Wuhu, ChinaContact removed (no phone or email listed)
    • Xiamen Xianyue Hospital · Xiamen, ChinaContact removed (no phone or email listed)
    • Xianyang Hospital of Yan'an University · Xianyang, ChinaContact removed •••9709Contact removed (no phone or email listed)
    • Psychiatric Hospital of Henan Province · Xinxiang, ChinaContact removed (no phone or email listed)
    • Zhenjiang Mental Health Center · Zhenjiang, ChinaContact removed •••2603Contact removed (no phone or email listed)
    • Zhumadian Psychiatric Hospital · Zhumadian, ChinaContact removed (no phone or email listed)
    • FutureMeds Berlin · Berlin, GermanyContact removed •••1239Contact removed (no phone or email listed)
    • Velocity Clinical Research, Berlin · Berlin, GermanyContact removed •••9400Contact removed (no phone or email listed)
    • Klinische Forschung Dresden · Dresden, GermanyContact removed •••2780Contact removed (no phone or email listed)
    • Klinische Forschung Hamburg · Hamburg, GermanyContact removed •••7630Contact removed (no phone or email listed)
    • Zentralinstitut für Seelische Gesundheit · Mannheim, GermanyContact removed •••3888Contact removed (no phone or email listed)
    • …and 3 more sites
    + 1 other change: verification date
  2. Oct 8, 2026
    29 sites changed recruiting status (29 now active, not recruiting)
    Show 29 sites
    • Headlands Research - Scottsdale · Scottsdale, United StatesRecruiting→Active, not recruiting
    • Woodland International Research Group · Little Rock, United StatesRecruiting→Active, not recruiting
    • UCLA Clinical & Translational Research Center (CTRC) · Los Angeles, United StatesRecruiting→Active, not recruiting
    • Artemis Institute for Clinical Research · Riverside, United StatesRecruiting→Active, not recruiting
    • Artemis Institute for Clinical Research · San Diego, United StatesRecruiting→Active, not recruiting
    • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay · San Francisco, United StatesRecruiting→Active, not recruiting
    • Accel Research Sites - Lakeland Clinical Research Unit · Lakeland, United StatesRecruiting→Active, not recruiting
    • Innovative Clinical Research · Lauderhill, United StatesRecruiting→Active, not recruiting
    • K2 Medical Research - Maitland · Maitland, United StatesRecruiting→Active, not recruiting
    • K2 Medical Research ORLANDO · Maitland, United StatesRecruiting→Active, not recruiting
    • Life Arc Research Centers - Miami · Miami, United StatesRecruiting→Active, not recruiting
    • Wellness Research Center · Miami, United StatesRecruiting→Active, not recruiting
    • Life Medical Research Group Corp · Miami Gardens, United StatesRecruiting→Active, not recruiting
    • Charter Research - Orlando · Orlando, United StatesRecruiting→Active, not recruiting
    • K2 Medical Research - Tampa · Tampa, United StatesRecruiting→Active, not recruiting
    • Re:Cognition Health - Chicago · Chicago, United StatesRecruiting→Active, not recruiting
    • Maryland Treatment Centers - Mountain Manor Treatment Center · Baltimore, United StatesRecruiting→Active, not recruiting
    • Maryland Treatment Centers - Avery Road Treatment Center · Rockville, United StatesRecruiting→Active, not recruiting
    • Adams Clinical Boston · Boston, United StatesRecruiting→Active, not recruiting
    • K2 Medical Research - Foxborough · Foxborough, United StatesRecruiting→Active, not recruiting
    • Adams Clinical Bronx · The Bronx, United StatesRecruiting→Active, not recruiting
    • Penn Medicine: University of Pennsylvania Health System · Philadelphia, United StatesRecruiting→Active, not recruiting
    • Brown University School of Public Health · Providence, United StatesRecruiting→Active, not recruiting
    • Avera Research Institute - Sioux Falls · Sioux Falls, United StatesRecruiting→Active, not recruiting
    • Modern Research Associates, PLLC · Dallas, United StatesRecruiting→Active, not recruiting
    • Adams Clinical Dallas · DeSoto, United StatesRecruiting→Active, not recruiting
    • Biopharma Informatic, LLC · Houston, United StatesRecruiting→Active, not recruiting
    • Re:Cognition Health · Fairfax, United StatesRecruiting→Active, not recruiting
    • Chang Gung Medical Foundation-Linkou Branch · Taoyuan, TaiwanRecruiting→Active, not recruiting
    Site contacts Changed at 29 sites. See the sites
    Show 29 sites
    • Headlands Research - Scottsdale · Scottsdale, United StatesContact removed (no phone or email listed)
    • Woodland International Research Group · Little Rock, United StatesContact removed •••8681Contact removed (no phone or email listed)
    • UCLA Clinical & Translational Research Center (CTRC) · Los Angeles, United StatesContact removed •••5383Contact removed (no phone or email listed)
    • Artemis Institute for Clinical Research · Riverside, United StatesContact removed •••1190Contact removed (no phone or email listed)
    • Artemis Institute for Clinical Research · San Diego, United StatesContact removed •••3647Contact removed (no phone or email listed)
    • UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay · San Francisco, United StatesContact removed (no phone or email listed)
    • Accel Research Sites - Lakeland Clinical Research Unit · Lakeland, United StatesContact removed •••2087Contact removed (no phone or email listed)
    • Innovative Clinical Research · Lauderhill, United StatesContact removed •••1971Contact removed (no phone or email listed)
    • K2 Medical Research - Maitland · Maitland, United StatesContact removed (no phone or email listed)
    • K2 Medical Research ORLANDO · Maitland, United StatesContact removed •••5252Contact removed (no phone or email listed)
    • Life Arc Research Centers - Miami · Miami, United StatesContact removed (no phone or email listed)
    • Wellness Research Center · Miami, United StatesContact removed •••2623Contact removed (no phone or email listed)
    • Life Medical Research Group Corp · Miami Gardens, United StatesContact removed •••4111Contact removed (no phone or email listed)
    • Charter Research - Orlando · Orlando, United StatesContact removed (no phone or email listed)
    • K2 Medical Research - Tampa · Tampa, United StatesContact removed •••5252Contact removed (no phone or email listed)
    • Re:Cognition Health - Chicago · Chicago, United StatesContact removed (no phone or email listed)
    • Maryland Treatment Centers - Mountain Manor Treatment Center · Baltimore, United StatesContact removed (no phone or email listed)
    • Maryland Treatment Centers - Avery Road Treatment Center · Rockville, United StatesContact removed (no phone or email listed)
    • Adams Clinical Boston · Boston, United StatesContact removed (no phone or email listed)
    • K2 Medical Research - Foxborough · Foxborough, United StatesContact removed •••8950Contact removed (no phone or email listed)
    • Adams Clinical Bronx · The Bronx, United StatesContact removed (no phone or email listed)
    • Penn Medicine: University of Pennsylvania Health System · Philadelphia, United StatesContact removed •••1943Contact removed (no phone or email listed)
    • Brown University School of Public Health · Providence, United StatesContact removed (no phone or email listed)
    • Avera Research Institute - Sioux Falls · Sioux Falls, United StatesContact removed •••3154Contact removed (no phone or email listed)
    • Modern Research Associates, PLLC · Dallas, United StatesContact removed (no phone or email listed)
    • Adams Clinical Dallas · DeSoto, United StatesContact removed (no phone or email listed)
    • Biopharma Informatic, LLC · Houston, United StatesContact removed •••3610Contact removed (no phone or email listed)
    • Re:Cognition Health · Fairfax, United StatesContact removed (no phone or email listed)
    • Chang Gung Medical Foundation-Linkou Branch · Taoyuan, TaiwanContact removed (no phone or email listed)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07219953
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 22, 2025
Start date
Oct 16, 2025
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 am - 8 pm Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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