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RecruitingNCT07219966RENEW-ALC-1Updated Oct 7, 2026

A Study of Brenipatide in Participants With Moderate-to-Severe Alcohol Use Disorder

A Phase 3 interventional study of LY3537031 and Placebo in Alcohol Use Disorder, sponsored by Eli Lilly and Company. Recruiting at 117 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

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 Oct 7, 2026Site recruiting status changedGo to Updates ↓

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Phase
Phase 3
Study type
Interventional
Enrollment
1,100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,073 studies in Alcoholism with a site in United States — 187 open to participants now, 228 under way, 15 of them phase 3. Alcoholism · United States.

Planned enrollment
25th of 989
1,100 · median 80
Started
2025
with 55 others
Phase 3
48 of 1,073
7 open now
Primary completion
2028-04
later than 152 of 227 live
Registered
1,026th of 1,073
by date

Among the 1,073 studies in Alcoholism with a site in United States, this one is the 25th largest by planned enrollment of the 989 interventional ones that give a count, is one of 56 that started in 2025, is one of 48 in phase 3, reaches primary completion later than 152 of the 227 other live ones, and was the 1,026th registered.

Alcoholism

1,676 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

Browse Alcoholism studies →

Open to participants now

187 of the 1,073 studies in Alcoholism with a site in United States are open now. Recruiting first, the newest first:

182 more — sign in →

All 187 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 237 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 131 (55%) stop at 75 or younger; 9 take children under 18; 64 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,073 studies in Alcoholism with a site in United States, or all of them as a file.
02

Study summary

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

03

Conditions studied

  • Alcohol Use Disorder

Browse trials for

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
    • 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 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

4 of 117 sites recruiting
  • Parkway Medical Center
    Birmingham, Alabama 35215, United States
    Completed

    Not enrolling at this site — choose another above.

  • 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
    Completed

    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
    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.

  • Mountain Mind - Denver
    Denver, Colorado 80202, 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.

  • 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
    Recruiting
    • Marc Fishman · Principal investigator
  • 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

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

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  • North Star Medical Research
    Middleburg Heights, Ohio 44130, United States
    Completed

    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.

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

    Not enrolling at this site — choose another above.

  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
    Recruiting
    • · Contact214-645-6950
    • Sherwood Brown · Principal investigator
  • Adams Clinical Dallas
    DeSoto, Texas 75115, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Pillar Clinical Research - Richardson
    Richardson, Texas 75080, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Alpine Research Organization
    Clinton, Utah 84015, 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.

  • University of Washington Medical Center - Montlake
    Seattle, Washington 98195, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • ANIMA Research
    Diepenbeek, 3590, Belgium
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kormont
    Kluisbergen, 9690, Belgium
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Gezondheidshuis De Gloed
    Machelen, 9870, Belgium
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Meclinas
    Mechelen, 2800, Belgium
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Medisch Centrum Saffrou
    Oudenaarde, 9636, Belgium
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • 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
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • 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.

  • 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.

  • Huzhou Third Municipal Hospital
    Huzhou, 313000, China
    Active, not recruiting

    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 Affiliated hospital of Southwest Medical University
    Luzhou, 646000, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Third Hospital of Mianyang
    Mianyang, 621000, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The First Affiliated Hospital of Nanchang University
    Nanchang, 330006, 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.

  • Tianjin Anding Hospital
    Tianjin, 300022, 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
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • 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.

  • 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
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Ai Sakura Clinic
    Fukuoka, 810-0001, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hiro Mental Clinic
    Fukuoka, 810-0004, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kuramitsu Hospital
    Fukuoka, 819-0037, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Rainbow and Sea Hospital
    Karatsu, 847-0031, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kariya Hospital
    Kariya, 448-0851, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Tatsuta Clinic
    Kobe, 651-0097, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Arata Clinic
    Nagasaki, 852-8137, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Yokogawa Ekimae Clinic
    Nishi, 733-0011, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sangenjaya Shinkeika Shinryonaika Clinic
    Setagaya City, 154-0004, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hillside Clinic Jingumae
    Shibuya City, 150-0001, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kaedenomori Mental Clinic
    Shibuya City, 150-0022, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Samoncho Clinic
    Shinjuku, 160-0017, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Keiai Clinic
    Shinjuku-ku, 160-0004, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Higashi Shinjuku Clinic
    Shinjuku-ku, 169-0072, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sakurazaka Clinic SophyAnce
    Tokyo, 106-0032, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Noguchi Naika Clinic
    Tokyo, 165-0031, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Tsukuba University Hospital
    Tsukuba, 305-8576, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Maekawa Medical Clinic
    Yokohama, 220-0004, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • National Hospital Organization Hizen Psychiatric Medical Center
    Yoshinogari-cho, Kanzaki-gun, 842-0192, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Pusan National University Yangsan Hospital
    Busan, 50612, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Chungbuk National University Hospital
    Cheongju-si, 28644, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hanyang University Guri Hospital
    Guri-si, 11923, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kyungpook National University Hospital
    Junggu, 41944, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Gachon University Gil Medical Center
    Namdong-gu, 21565, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Konyang University Hospital
    Seogu, 35365, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Seoul National University Bundang Hospital
    Seongnam, 13620, South Korea
    Recruiting
    • Kiheon Lee · Principal investigator
  • Seoul National University Hospital
    Seoul, 03080, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hanyang University Seoul Hospital
    Seoul, 04763, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital
    Seoul, 06591, South Korea
    Active, not recruiting

    Not enrolling at this site — choose another above.

Showing the first 100 of 117 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

1 registry update 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 15, 2025
Primary completionEst.
Apr 2028
CompletionEst.
Apr 2028
Last update
Oct 7, 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
67 sites changed recruiting status (64 now active, not recruiting, 3 now completed)
Show 67 sites
  • Parkway Medical Center · Birmingham, United StatesNot yet recruiting→Completed
  • Headlands Research - Scottsdale · Scottsdale, United StatesRecruiting→Active, not recruiting
  • Woodland International Research Group · Little Rock, United StatesRecruiting→Completed
  • UCLA Clinical & Translational Research Center (CTRC) · Los Angeles, 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
  • Mountain Mind - Denver · Denver, United StatesRecruiting→Active, not recruiting
  • Accel Research Sites - Lakeland Clinical Research Unit · Lakeland, 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
  • 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
  • North Star Medical Research · Middleburg Heights, United StatesRecruiting→Completed
  • Penn Medicine: University of Pennsylvania Health System · Philadelphia, United StatesRecruiting→Active, not recruiting
  • Avera Research Institute - Sioux Falls · Sioux Falls, United StatesRecruiting→Active, not recruiting
  • Adams Clinical Dallas · DeSoto, United StatesRecruiting→Active, not recruiting
  • Pillar Clinical Research - Richardson · Richardson, United StatesRecruiting→Active, not recruiting
  • Alpine Research Organization · Clinton, United StatesRecruiting→Active, not recruiting
  • Re:Cognition Health · Fairfax, United StatesRecruiting→Active, not recruiting
  • University of Washington Medical Center - Montlake · Seattle, United StatesRecruiting→Active, not recruiting
  • Beijing Anding Hospital - Affiliated Capital University of Medical Science · Beijing, ChinaRecruiting→Active, not recruiting
  • Beijing HuiLongGuan Hospital · Beijing, ChinaRecruiting→Active, not recruiting
  • …and 37 more on the registry record
Oct 7, 2026
Site contacts
Changed at 67 sites. See the sites
Show 67 sites
  • Parkway Medical Center · Birmingham, United StatesContact removed •••2601Contact removed (no phone or email listed)
  • 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 · 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)
  • Mountain Mind - Denver · Denver, 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)
  • 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)
  • 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)
  • North Star Medical Research · Middleburg Heights, 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)
  • Avera Research Institute - Sioux Falls · Sioux Falls, United StatesContact removed •••3154Contact removed (no phone or email listed)
  • Adams Clinical Dallas · DeSoto, United StatesContact removed (no phone or email listed)
  • Pillar Clinical Research - Richardson · Richardson, United StatesContact removed •••4844Contact removed (no phone or email listed)
  • Alpine Research Organization · Clinton, United StatesContact removed •••3292Contact removed (no phone or email listed)
  • Re:Cognition Health · Fairfax, United StatesContact removed (no phone or email listed)
  • University of Washington Medical Center - Montlake · Seattle, United StatesContact removed (no phone or email listed)
  • Beijing Anding Hospital - Affiliated Capital University of Medical Science · Beijing, ChinaContact removed (no phone or email listed)
  • Beijing HuiLongGuan Hospital · Beijing, ChinaContact removed (no phone or email listed)
  • …and 37 more sites
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    67 sites changed recruiting status (64 now active, not recruiting, 3 now completed)
    Show 67 sites
    • Parkway Medical Center · Birmingham, United StatesNot yet recruiting→Completed
    • Headlands Research - Scottsdale · Scottsdale, United StatesRecruiting→Active, not recruiting
    • Woodland International Research Group · Little Rock, United StatesRecruiting→Completed
    • UCLA Clinical & Translational Research Center (CTRC) · Los Angeles, 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
    • Mountain Mind - Denver · Denver, United StatesRecruiting→Active, not recruiting
    • Accel Research Sites - Lakeland Clinical Research Unit · Lakeland, 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
    • 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
    • North Star Medical Research · Middleburg Heights, United StatesRecruiting→Completed
    • Penn Medicine: University of Pennsylvania Health System · Philadelphia, United StatesRecruiting→Active, not recruiting
    • Avera Research Institute - Sioux Falls · Sioux Falls, United StatesRecruiting→Active, not recruiting
    • Adams Clinical Dallas · DeSoto, United StatesRecruiting→Active, not recruiting
    • Pillar Clinical Research - Richardson · Richardson, United StatesRecruiting→Active, not recruiting
    • Alpine Research Organization · Clinton, United StatesRecruiting→Active, not recruiting
    • Re:Cognition Health · Fairfax, United StatesRecruiting→Active, not recruiting
    • University of Washington Medical Center - Montlake · Seattle, United StatesRecruiting→Active, not recruiting
    • Beijing Anding Hospital - Affiliated Capital University of Medical Science · Beijing, ChinaRecruiting→Active, not recruiting
    • Beijing HuiLongGuan Hospital · Beijing, ChinaRecruiting→Active, not recruiting
    • …and 37 more on the registry record
    Site contacts Changed at 67 sites. See the sites
    Show 67 sites
    • Parkway Medical Center · Birmingham, United StatesContact removed •••2601Contact removed (no phone or email listed)
    • 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 · 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)
    • Mountain Mind - Denver · Denver, 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)
    • 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)
    • 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)
    • North Star Medical Research · Middleburg Heights, 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)
    • Avera Research Institute - Sioux Falls · Sioux Falls, United StatesContact removed •••3154Contact removed (no phone or email listed)
    • Adams Clinical Dallas · DeSoto, United StatesContact removed (no phone or email listed)
    • Pillar Clinical Research - Richardson · Richardson, United StatesContact removed •••4844Contact removed (no phone or email listed)
    • Alpine Research Organization · Clinton, United StatesContact removed •••3292Contact removed (no phone or email listed)
    • Re:Cognition Health · Fairfax, United StatesContact removed (no phone or email listed)
    • University of Washington Medical Center - Montlake · Seattle, United StatesContact removed (no phone or email listed)
    • Beijing Anding Hospital - Affiliated Capital University of Medical Science · Beijing, ChinaContact removed (no phone or email listed)
    • Beijing HuiLongGuan Hospital · Beijing, ChinaContact removed (no phone or email listed)
    • …and 37 more sites
    + 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
NCT07219966
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Oct 22, 2025
Start date
Oct 15, 2025
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Oct 7, 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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