Alcohol Use DisorderPhase 2NCT06817356
A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
A Phase 2 study testing Mazdutide in people with Alcohol Use Disorder, run by Eli Lilly and Company at 25 sites in United States.
Trial summary
The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD). For any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Mazdutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 25 sitesUnited States
- Study dates
- 6 Feb 2025to 19 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria.
Who cannot join
- Have a history of significant active or unstable major depressive disorder, suicidal ideation, or other severe psychiatric disorder within the last 12 months.
- Have initiated psychotherapy, changed the intensity of psychotherapy, or other nondrug therapies (for example, acupuncture or hypnosis) within 8 weeks prior to enrollment.
- Have received any medication for AUD in the last 30 days including but not limited to, disulfiram, acamprosate, naltrexone, gabapentin, baclofen, or topiramate.
- Other protocol-specific inclusion and exclusion criteria may apply.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
FutureSearch Trials of Dallas
Dallas, Texas, 75251
CenExel iResearch, LLC (CenExel iRA)
Decatur, Georgia, 30030
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914
Ark Clinical Research - Fountain Valley
Fountain Valley, California, 92708
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
Redbird Research LLC
Las Vegas, Nevada, 89119
Synergy San Diego
Lemon Grove, California, 91945
K2 Medical Research - Maitland
Maitland, Florida, 32751
K2 Medical Research
Maitland, Florida, 32751
DelRicht Research
Mandeville, Louisiana, 70471
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119
Clinical Neuroscience Solutions Inc
Orlando, Florida, 32801
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Summit Headlands
Portland, Oregon, 97210
Dallas Clinical Research Center/Pillar Research
Richardson, Texas, 75080
Woodland Resarch Northwest/ERG
Rogers, Arkansas, 72758
Headlands Research-Artemis San Diego
San Diego, California, 92123
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260
Richmond Behavioral Associates
Staten Island, New York, 10314
Ichor Research
Syracuse, New York, 13210
K2 Medical Research - Tampa
Tampa, Florida, 33634
Davis Clinical
The Bronx, New York, 10461
Adams Clinical
Watertown, Massachusetts, 02472
Vitalix Clinical
Worcester, Massachusetts, 01608
About this study
Official title: A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD).
For any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.
- Conditions
- Alcohol Use Disorder
- Being tested
- Mazdutide, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MazdutideDrug
Also called LY3305677
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Mazdutide | Experimental | Mazdutide administered subcutaneously (SC). Receives: Drug: Mazdutide |
| Placebo | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method
Measured: Baseline, Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start6 Feb 2025
- Primary completion19 Mar 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817356
- Sponsor's protocol ID
- 27290
- Other IDs
- I8P-MC-OXAH
- Status last verified
- Jul 2026
- First submitted
- 5 Feb 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT06817356
- Acronym / sponsor ID
- 27290
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this proof-of-concept study to evaluate mazdutide in participants with alcohol use disorder (AUD).
For any individual participant, the maximum duration of study participation is approximately 36 weeks, including screening and posttreatment follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mazdutide | Experimental | Drug: MazdutideMazdutide administered subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria.
Key exclusion criteria (4 listed)
- Have a history of significant active or unstable major depressive disorder, suicidal ideation, or other severe psychiatric disorder within the last 12 months.
- Have initiated psychotherapy, changed the intensity of psychotherapy, or other nondrug therapies (for example, acupuncture or hypnosis) within 8 weeks prior to enrollment.
- Have received any medication for AUD in the last 30 days including but not limited to, disulfiram, acamprosate, naltrexone, gabapentin, baclofen, or topiramate.
- Other protocol-specific inclusion and exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MazdutideAlso: LY3305677Administered SC | Drug | Mazdutide |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method
Time frame: Baseline, Week 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mazdutide in people with Alcohol Use Disorder, run by Eli Lilly and Company at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method (time frame: Baseline, Week 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.