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Trial · Interventional

CompletedPhase 2Registry data

Does Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?

Short name SEMALCO

NCTNCT05895643 (opens ClinicalTrials.gov in a new tab)Other idThe SEMALCO studyOther idU1111-1286-6919

Overview

Status
Completed
Phase
Phase 2
Enrollment
108 participants (actual)
Sponsor
Psychiatric Centre Rigshospitalet · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
13 Jun 2023
Primary completion
31 Jul 2025
Completion
31 Jul 2025
First posted
8 Jun 2023
Last update posted
5 Aug 2025
Conditions
Alcohol Abuse · Alcohol Addiction · Alcohol Dependence · Alcohol Use Disorder

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 2

    SEMALCO

    NCT05895643

    13 Jun 2023 to 31 Jul 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This 26-week long, double-blinded randomized clinical trial aims to investigate the effects of the GLP-1 receptor agonist semaglutide s.c. vs placebo on alcohol consumption in 108 patients diagnosed with alcohol use disorder and comorbid obesity (BMI\>30 kg/m2). Patients will be treated for 26 weeks with semaglutide subcutaneously (s.c.) once weekly or placebo. The medication will be provided as a supplement to standardised cognitive behavioural therapy. A subgroup of the patients will have two brain scans (Magnetic Resonance Spectroscopy (MRS) and functional Magnetic Resonance Imaging (fMRI)) conducted in one scan session at week 0 and 26. The primary endpoint is the percentage-point reduction in total number of heavy drinking days, defined as days with an excess intake of 48/60 grams of alcohol per day (women and men, respectively) from baseline to follow-up after 26 weeks of treatment, measured by the timeline followback (TLFB) method.

Interventions

  • Semaglutide Injectable ProductDrug
  • PlaceboDrug

Arms2

  • Experimental

    semaglutide

    Wegovy once-weekly s.c.titrated to a maximum dose of 2.4 mg

  • Placebo comparator

    placebo

    Saline s.c. once-weekly

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in heavy drinking days

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in alcohol consumption, defined as the change in percentage of heavy drinking days during a period of 30 consecutive days, after 26 weeks of treatment adjusted for baseline (percentage points (pp)). A heavy drinking day is defined as more than 60/48 grams (men/women) of alcohol in one day, measured with the validated timeline follow-back (TLFB) method.

Secondary outcomes(20)
  1. Change in heavy drinking days adjusted for maximum tolerable semaglutide dose given

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in heavy drinking days during a period of 30 consecutive days, after 26 weeks of treatment adjusted for baseline (percentage points (pp)) and maximum tolerable semaglutide dose given.

  2. Change in heavy drinking days adjusted for weightloss

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in heavy drinking days during a period of 30 consecutive days, after 26 weeks of treatment adjusted for baseline (percentage points (pp)) and weight loss during the 26 weeks of treatment

  3. Total alcohol consumption

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in total alcohol consumption /gram/last 30 consecutive days)

  4. Drinks per day

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in total drinks per day (last 30 consecutive days)

  5. Days without alcohol consumption

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Number of days without alcohol consumption in the last 30 consecutive days

  6. Time to relapse

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Time to relapse, defined as the time to first alcohol intake

  7. Time to relapse (heavy drinking day)

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Time to first heavy drinking day

  8. World Health Organization (WHO) Risk Levels of Alcohol Consumption

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in WHO alcohol risk level in the last 30 consecutive days, measured with the validated timeline follow-back (TLFB) method.

  9. Penn Alcohol Craving Scale (PACS) score

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in Penn Alcohol Craving Scale (PACS) score. Minimum score = 0, maximum score =30. A high score means a worse outcome.

  10. Alcohol Use Disorder Identification Test (AUDIT) score

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in Alcohol Use Disorder Identification Test (AUDIT) score. Minimum score = 0, maximum score =40. A high score means a worse outcome.

  11. Drug Use Disorders Identification Test (DUDIT) score

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in Drug Use Disorders Identification Test (DUDIT) score. Minimum score = 0, maximum score =44. A high score means a worse outcome.

  12. Fibrosis-4 (FIB4) score

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in Fibrosis-4 (FIB4) score, calculated from the parameters: the patient's age, blood aspartate aminotransferase levels (ASAT), thrombocytes and alanine transaminase (ALAT). A higher score means a worse outcome.

  13. Measure of life quality - World Health Organization Quality of Life brief (WHOQOL-BREF) score

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in Measures of Health (WHOQOL-BREF) score. Minimum score = 26, maximum score =130. Higher scores mean a better outcome in items 1-2 + 10-25. A higher score in items 3-9 + 26 means a worse outcome.

  14. Fagerströms Test for Nicotine Dependence score

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in Fagerströms Test for Nicotine Dependence score. Minimum score = 0, maximum score =10. A high score means a worse outcome.

  15. Gamma-glutamyl transferase (GGT)

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in blood gamma-glutamyl transferase (GGT)

  16. Alanine transaminase (ALAT)

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in blood alanine transaminase (ALAT)

  17. Phosphatidyl ethanol (PEth)

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in plasma levels of phosphatidyl ethanol (PEth)

  18. Mean cell volume (MCV)

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in blood mean cell volume (MCV)

  19. Body weight

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in Body weight

  20. Blood pressure

    Time frame · From baseline to 26 weeks of treatment

    Registry description

    Change in blood pressure (both systolic and diastolic)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

2 results

Once-weekly semaglutide versus placebo in patients with alcohol use disorder and comorbid obesity: a randomised, double-blind, placebo-controlled trial.

Klausen et al. 2026Lancet (London, England)cited by 20

PMID 42070571DOI 10.1016/s0140-6736(26)00305-3PUB-42070571

Full text at the publisher2 results

Indexing hint: Clinical trial · 2025

Does semaglutide reduce alcohol intake in Danish patients with alcohol use disorder and comorbid obesity? Trial protocol of a randomised, double-blinded, placebo-controlled clinical trial (the SEMALCO trial).

Klausen et al. 2025BMJ opencited by 12

PMID 39779270PMC11749217DOI 10.1136/bmjopen-2024-086454PUB-39779270

Free to read · publisher termsCC BY-NC
Read at source

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedJensen ME, Klausen MK, Bergmann ML, Knudsen GM, Vilsboll T, Stove C, Fink-Jensen A. Blood phosphatidylethanol measurements indicate GLP-1 receptor stimulation causes delayed decreases in alcohol consumption. Alcohol Clin Exp Res (Hoboken). 2025 May;49(5):1161-1165. doi: 10.1111/acer.70041. Epub 2025 Mar 23. PMID 40123107

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Informed oral and written consent * Diagnosed with alcohol dependence according to the criteria of the International Classification of Diseases 10 (ICD-10), and diagnosed with alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Alcohol use disorder identification test (AUDIT) score \>15 * Body mass index (BMI) above or equal to 30 kg/m2 * Age 18 - 70 years (both included) * Heavy alcohol drinking defined as more than 6 days with alcohol consumption over 4 units (48 g alcohol) for women and 5 units (60 g alcohol) for men during a consecutive 30-day period, within 40 days prior to baseline evaluation, measured by the TLFB method. The 30-day period will be the 30 consecutive days with the biggest alcohol intake (most heavy drinking days and the largest amount of total alcohol) out of the 40 days. Exclusion Criteria: * Severe psychiatric disease, defined as a diagnosis of schizophrenia, paranoid psychosis, bipolar disorder or mental retardation * A history of delirium tremens or alcohol withdrawal seizures * No serious withdrawal symptoms at inclusion (a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)) at baseline examinations * Present or former neurological disease, including traumatic brain injury * Type 1 diabetes, type 2 diabetes in poor glycaemic control (defined as HbA1c ≥48 mmol/l or fasting plasma glucose above 7.0 mmol/l at inclusion) * Females of childbearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant within the next 9 months (26 weeks plus two months after discontinuation of semaglutide), or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device, bilateral tubal occlusion, vasectomised partner, sexual abstinence). * Pregnancy (serum human chorionic gonadotropin (hCG) \> 3 U/L at inclusion) * Impaired hepatic function (liver transaminases \>3 times the upper limit) * Impaired renal function (eGFR \< 50 ml/min and/or plasma creatinine \>150 μmol/l) * Impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase \> 2 times upper limit) * Former medullary thyroid carcinoma (MTC) and/or family history with MTC and/or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) * Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months * Uncontrolled hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>110 mmHg) * Concomitant pharmacotherapy against alcohol use disorder, i.e., disulfiram, naltrexone, acamprosate, or nalmefene, since the first of the 30 drinking days registered for inclusion at the TLFB-schedule. * Receiving any investigational drug within the last three months * Use of weight-lowering pharmacotherapy within the preceding 3 months * Any other active substance use defined as a DUDIT-score \>1 (except nicotine) * Hypersensitivity to the active substance or any of the excipients * Only for patients undergoing brain scans: o Contraindications for undergoing an MRI scan (magnetic implants, pacemaker, claustrophobia, etc.) * Unable to speak and/or understand Danish * Any condition that the investigator feels would interfere with trial participation

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