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Trial · Interventional

CompletedPhase 2Registry data

A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

NCTNCT06817356 (opens ClinicalTrials.gov in a new tab)Other id27290Other idI8P-MC-OXAH
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
308 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
6 Feb 2025
Primary completion
19 Mar 2026
Completion
19 May 2026
First posted
10 Feb 2025
Last update posted
16 Jul 2026
Conditions
Alcohol Use Disorder

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 2

    A Study to Evaluate Mazdutide Compared With Placebo in Participants With Alcohol Use Disorder

    NCT06817356

    6 Feb 2025 to 19 May 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • MazdutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Mazdutide

    Mazdutide administered subcutaneously (SC).

  • Placebo comparator

    Placebo

    Placebo administered SC.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Behaviors Associated with Alcohol Use Disorder (AUD) as Assessed by the Timeline Followback Method

    Time frame · Baseline, Week 28

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Current AUD diagnosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria. Exclusion Criteria: * 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.

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