LivingGLP1
Study S000942

A Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Phase 2 Study of Efficacy and Safety of Tirzepatide in Individuals With Alcohol Use Disorder and Metabolic Alcohol-associated Liver Disease

Registration

Registration
NCT07046819
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE2
Masking
DOUBLE
Status
RECRUITING
Enrollment
120
Start
2026-06-11
Primary completion
2027-07-30
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
Metabolic Alcohol-associated Liver Disease; Alcohol Use Disorder
Interventions
DRUG:Tirzepatide; OTHER:Placebo
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:002246-AA

Registered primary outcomes

  • Metabolic improvement from baseline as measured by percentage reduction of body weight and reduction in liver steatosis from baseline as measured by percentage reduction in Fibroscan controlled attenuation parameter (CAP) score. [Change from baseline to week 12]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0014066LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept.
Coskun T, Molecular metabolism
2018Randomized trialPMID 30473097DOIregistry reference BACKGROUND:30473097