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