BridgeMD
SEMALCO
EU CTIS ID: 2023-503371-25-00
What this study is testing
Does the glucagon-like peptide 1 (glp-1) receptor agonist semaglutide reduce alcohol intake in patients with alcohol use disorder and comorbid obesity?
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 days with the biggest alcohol intake (most heavy drinking days and the largest amount of total alcohol) out of the 40 days.
You likely can't join if
- Severe psychiatric disease, defined as a diagnosis of schizophrenia, paranoid psychosis, bipolar disorder or mental retardation
- 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 pec-toris 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.
See the full eligibility criteria
Who can join
- 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 days with the biggest alcohol intake (most heavy drinking days and the largest amount of total alcohol) out of the 40 days.
What rules you out
- Severe psychiatric disease, defined as a diagnosis of schizophrenia, paranoid psychosis, bipolar disorder or mental retardation
- 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 pec-toris 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: Contraindications for undergoing an MRI scan (magnetic implants, pacemaker, claustro-phobia, etc.)
- A history of delirium tremens or alcohol withdrawal seizures
- Unable to speak and/or understand Danish
- Any condition that the investigator feels would interfere with trial participation
- No serious withdrawal symptoms at inclusion (a score higher than 9 on the Clinical Institute With-drawal 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 three 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 – IUD, IUS, 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.