DelfaGLP-1 Atlas

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SEMALCO

CompletedPhase 2

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

Does the Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Semaglutide Reduce Alcohol Intake in Patients With Alcohol Use Disorder and Comorbid Obesity?

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

108

actual

Study population

Alcohol / substance use, Obesity / overweight

Key I/E criterion

—

Primary endpoint

•Alcohol consumption, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05895643
Org study IDThe SEMALCO study
Secondary IDU1111-1286-6919Universal Trial Number

Timeline

Milestones

Study first posted2023-06-08actual
Study start2023-06-13actual
Primary completion2025-07-31actual
Study completion2025-07-31actual
Last update posted2025-08-05actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Alcohol / substance useObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
14
MASH / liver
3
Other (unclassified)
3
Weight & body composition
2
Cardiometabolic biomarkers
2
Glycemic / diabetes
1
Patient-reported / QoL
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Body weight

Time frame:From baseline to 26 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:From baseline to 26 weeks of treatment

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Glycaemic control parameters

Time frame:From baseline to 26 weeks of treatment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

3 endpoints
Secondary/protocol endpoint

Fibrosis-4 (FIB4) score

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Gamma-glutamyl transferase (GGT)

Time frame:From baseline to 26 weeks of treatment

γ-GT, change

change from baseline, improvement

Secondary/protocol endpoint

Alanine transaminase (ALAT)

Time frame:From baseline to 26 weeks of treatment

ALT, change

change from baseline, improvement

LOINC 1742-6

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Blood pressure

Time frame:From baseline to 26 weeks of treatment

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Pulse

Time frame:From baseline to 26 weeks of treatment

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

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

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Other clinical outcomes

14 endpoints
Primary/protocol endpoint

Change in heavy drinking days

Time frame:From baseline to 26 weeks of treatment

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Change in heavy drinking days adjusted for maximum tolerable semaglutide dose given

Time frame:From baseline to 26 weeks of treatment

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Change in heavy drinking days adjusted for weightloss

Time frame:From baseline to 26 weeks of treatment

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Total alcohol consumption

Time frame:From baseline to 26 weeks of treatment

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Drinks per day

Time frame:From baseline to 26 weeks of treatment

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Days without alcohol consumption

Time frame:From baseline to 26 weeks of treatment

Alcohol consumption, change

change from baseline, improvement

Secondary/protocol endpoint

Time to relapse

Time frame:From baseline to 26 weeks of treatment

time to event, event

Secondary/protocol endpoint

Time to relapse (heavy drinking day)

Time frame:From baseline to 26 weeks of treatment

time to event, event

Secondary/protocol endpoint

World Health Organization (WHO) Risk Levels of Alcohol Consumption

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Penn Alcohol Craving Scale (PACS) score

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Alcohol Use Disorder Identification Test (AUDIT) score

Time frame:From baseline to 26 weeks of treatment

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Drug Use Disorders Identification Test (DUDIT) score

Time frame:From baseline to 26 weeks of treatment

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Fagerströms Test for Nicotine Dependence score

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

fMRI alcohol cue-reactivity

Time frame:From baseline to 26 weeks of treatment

change from baseline, improvement

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Phosphatidyl ethanol (PEth)

Time frame:From baseline to 26 weeks of treatment

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Mean cell volume (MCV)

Time frame:From baseline to 26 weeks of treatment

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

MRS brain gamma-aminobutyric acid (GABA) levels

Time frame:From baseline to 26 weeks of treatment

change from baseline, descriptive

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.