Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)

What Was Tested

This registered phase 1 trial tested Tirzepatide.

Background: Glucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss.

It had five arms (groups): [11C]NNC-112 - Part 2 (placebo comparator), [11C]raclopride plus drug - Part 1 (active comparator), [11C]raclopride plus drug - Part 2 (active comparator), Placebo - Part 2 (placebo comparator) and Tirzepatide - Part 2 (active comparator).

\[11C\]NNC-112 PET/MR or PET/CT scan obtained without any drug intervention to measure dopamine D1 receptors.

The registry classes the interventions as drug.

More on the Plan

Study Description: Protocol has 2 parts: Part 1 (n=5 healthy volunteers): Assess the reproducibility of striatal dopamine (DA) measures in response to iv methylphenidate (MP) using PET/MR combined scanning and the bolus infusion protocol in healthy controls.

Measures collected twice after placebo and after Tirzepatide Secondary Endpoints: Self-reports of drug effects (Parts 1 \& 2) Sleep measures: actigraphy and self-reports (Part 2).

Who Took Part

176 planned participants were the target.

It was open to people of any sex aged from 21 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Enrollment in 14AA0181. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female, ages 21-65 years old. Ability to understand and willingness to sign a written informed consent document. Enrollment in 14AA0181.

The full record lists 14 inclusion and 26 exclusion criteria; among the exclusions: presence of ferromagnetic objects in the body that are contraindicated for mri of the head, fear of enclosed spaces, or other standard contraindication to mri; cannot lie comfortably flat on his/her back for up to 2 hours in the pet/mri scanner; BMI \<23 or \>35 (but no more than 500 lbs). The PET/MRI scanner bed is tested to a weight limit of 500 lbs.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Tirzepatide and the comparison in turn, acting as their own control.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2026-05-20 with completion listed for 2031-12-31.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Part 1 (n=5 healthy volunteers): We will assess the reproducibility of striatal dopamine (DA) measures in response to iv methylphenidate (MP) using PET/MR combined scanning and the bolus infusion protocol in healthy controls (time frame: We aim to have each subject (n=5) complete all study procedures within 60 days).

It also tracked 2 secondary outcomes, for example Part 1: Subjective responses to MP.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 176 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.