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- Source: inbox/queue/2026-05-03-lancet-semalco-semaglutide-aud-rct-results.md - Domain: health - Claims: 1, Entities: 1 - Enrichments: 3 - Extracted by: pipeline ingest (OpenRouter anthropic/claude-sonnet-4.5) Pentagon-Agent: Vida <PIPELINE>
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SEMALCO Trial
Full name: Once-weekly semaglutide versus placebo in patients with alcohol use disorder and comorbid obesity
Institution: Mental Health Center Copenhagen, Psychiatric Centre Copenhagen
Trial type: Phase 2, randomized, double-blind, placebo-controlled
Status: Published April 2026 in The Lancet
Design
- Population: N=108 treatment-seeking patients with moderate-to-severe AUD + comorbid obesity (BMI ≥30 kg/m²)
- Duration: 26 weeks
- Intervention: Semaglutide 2.4mg subcutaneous weekly vs. placebo (saline), randomized 1:1
- Co-intervention: Both arms received standard cognitive behavioral therapy (CBT)
- Setting: Single-center (Mental Health Center Copenhagen)
Primary Outcome
Heavy drinking days reduction:
- Semaglutide: 41.1% reduction from baseline (95% CI −48.7 to −33.5)
- Placebo: 26.4% reduction (−34.1 to −18.6)
- Treatment difference: −13.7 percentage points (−22.0 to −5.4; p=0.0015)
- NNT = 4.3 (vs. NNT ≥7 for all FDA-approved AUD medications)
Secondary Outcomes
- No significant effect on: Average drinks/day, total drinking days
- Significant reductions in: Drinks per drinking day, weekly alcohol craving
- Objective validation: Blood-alcohol biomarkers confirmed self-reported findings
- Cross-substance effect: Greater cigarette reduction in subgroup with concurrent tobacco use
Safety
GI side effects (nausea, loss of appetite, constipation, vomiting) occurred significantly more frequently with semaglutide but were generally mild and transient.
Significance
- Largest RCT of semaglutide for AUD to date (previous: 48-person, 9-week, non-treatment-seeking trial)
- Superior efficacy to all currently approved AUD medications
- First Phase 2 evidence for GLP-1 receptor agonists in AUD with comorbid obesity
Limitations
- Single-center design reduces generalizability
- AUD+obesity comorbidity requirement — cannot extrapolate to AUD without obesity
- Both arms received CBT — unclear if semaglutide monotherapy would work
- 26 weeks — no long-term durability data post-discontinuation
Related Trials
- NCT05520775: "Semaglutide for Alcohol Use Disorder" (separate trial)
- NCT07218354: Phase 3 design, details limited
Timeline
- 2026-04-01 — Published in The Lancet
- 2026-04 — Covered by NIH press release, MedicalXpress, PsychNews, multiple outlets