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Semaglutide 2024-01-11 ClinicalTrials

Oral semaglutide trial investigates effects on alcohol craving and consumption in adults with AUD

Clinical Trial of Rybelsus (Semaglutide) Among Adults With Alcohol Use Disorder (AUD)

Background

Alcohol Use Disorder (AUD) represents a significant global health burden, characterized by impaired control over alcohol use, leading to substantial personal and societal costs. Current pharmacological treatments for AUD, such as naltrexone and acamprosate, often have limited efficacy or are associated with side effects that hinder adherence. There's a critical need for novel, well-tolerated therapeutic options. Emerging research suggests that glucagon-like peptide-1 receptor (GLP-1R) agonists, like semaglutide, may modulate reward pathways in the brain, particularly dopamine signaling, which is implicated in addiction. This mechanism offers a promising new avenue for targeting alcohol craving and consumption.

Study Design

This early-phase, human laboratory randomized controlled trial will enroll 50 treatment-seeking adults diagnosed with Alcohol Use Disorder (AUD). Participants will be randomly assigned to receive either oral semaglutide or a matched placebo. The semaglutide dose will be titrated up to 7 mg/day over the 8-week study duration. Primary aims include assessing the safety and tolerability of semaglutide in this population, as well as evaluating its effects, relative to placebo, on alcohol cue-elicited craving and overall alcohol consumption. This design aims to establish preliminary efficacy and safety data.

Results

As this is a description of an ongoing clinical trial, no findings are reported yet. The study is designed to evaluate the safety, tolerability, and effects of semaglutide on alcohol cue-elicited craving and alcohol consumption in adults with AUD. Results from this trial will provide crucial data on the potential of GLP-1R agonists as a novel treatment strategy for Alcohol Use Disorder.

Why It Matters

If successful, this trial could establish oral semaglutide as a novel, well-tolerated therapeutic option for Alcohol Use Disorder (AUD), addressing a significant unmet medical need. Its established safety profile for metabolic conditions and convenient oral formulation could accelerate clinical adoption compared to injectable alternatives. A positive outcome could lead to new treatment protocols, potentially offering a standalone or adjunctive therapy that targets both craving and consumption, thereby improving patient outcomes and adherence. This research is critical for understanding the broader therapeutic potential of GLP-1R agonists beyond metabolic diseases, opening doors for repurposing existing drugs for psychiatric conditions.

TitrateLab articles covering Semaglutide

Written by TitrateLab, separately from the study summarized above.


semaglutide alcohol use disorder aud glp-1 agonist clinical trial craving
Source: clinicaltrials:NCT05892432 · Ingested Oct 28, 2026 · Digest: gemini-2.5-flash