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HASHTAG
RecruitingPhase 2Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
A Randomized, Double-Blind, Placebo-Controlled Trial of Semaglutide for Reducing Cannabis Use in Adults With Cannabis Use Disorder
Lead sponsor
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
100
estimated
Study population
Alcohol / substance use
Key I/E criterion
•BMI ≥23
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Informed oral and written consent.
2. Meets the criteria for cannabis use disorder (CUD) according to DSM-5 or ICD-10.
3. Currently seeking to cut down or stop cannabis use.
4. Positive urine test for cannabinoids.
5. Body mass index (BMI) ≥ 23 kg/m².
6. Age 18-70 years.
7. Recent frequent cannabis use, defined as use on ≥16 days out of the past 28 days.
8. Cannabis use (smoked, vaped, edibles) equivalent to THC doses of ≥14 grams in the past 28 days before baseline.
9. Ability to comply with study procedures and follow-up.
Exclusion criteria
1. Currently meeting non-cannabis/tobacco substance use disorder (ICD-10 or DSM-5).
2. Current or past diagnosis of severe psychiatric illness, defined as schizophrenia, bipolar disorder, or other psychoses, within the past five years.
3. Suicide attempt or suicidal behavior within the past five years.
4. Severe neurological disorders, including previous severe traumatic brain injury, stroke, or intracranial hemorrhage.
5. Type 1 diabetes and type 2 diabetes.
6. Pregnant or potentially pregnant women: Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, planning to become pregnant within the next eight months (including 20 weeks of treatment plus two months after discontinuation of semaglutide), or not using effective contraception throughout the study period. Effective methods include combined hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, implant, injection), intrauterine device/system (IUD/IUS), bilateral tubal occlusion, partner with vasectomy, or sexual abstinence. WOCBP with a measured serum human chorionic gonadotropin (hCG) level >3 U/L at inclusion will also be excluded.
7. Impaired liver function (liver transaminases >3 times the upper reference limit)
8. Impaired renal function (eGFR <50 ml/min and/or plasma creatinine >150 µmol/L).
9. Impaired pancreatic function (past or current acute or chronic pancreatitis and/or amylase >2 times the upper limit).
10. History of medullary thyroid carcinoma (MTC) and/or family history of MTC and/or Multiple Endocrine Neoplasia type 2 (MEN 2).
11. Heart disease is defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, and/or myocardial infarction within the past 12 months.
12. Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg).
13. Receipt of experimental medication within the past 30 days.
14. Use of weight-loss medication within the past 3 months.
15. Hypersensitivity to the active substance or any of the excipients.
16. For patients undergoing brain scanning only:
Contraindications to MRI scanning (magnetic implants, pacemaker, claustrophobia, etc.).
17. Inability to speak and/or understand Danish.
18. Other conditions: Any other condition that, in the investigator's opinion, may interfere with participation in the trial.
Endpoints (24)
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
Weight & body composition
2 endpointsBody weight
Time frame:From baseline to week 20.
Body weight, % change
percent change from baseline, improvement
Body fat and metabolic risk
Time frame:From baseline to week 20.
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
1 endpointGlycaemic parameters
Time frame:From baseline to week 20.
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Cardiometabolic biomarkers
2 endpointsCardiovascular parameters
Time frame:From baseline to week 20.
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Cardiovascular parameters
Time frame:From baseline to week 20.
Heart rate, change
change from baseline, improvement
Patient-reported / QoL
3 endpointsDepression symptoms
Time frame:From baseline to week 20.
change from baseline, improvement
Subjective sleep quality
Time frame:From baseline to week 20.
change from baseline, improvement
Changes in Quality of life
Time frame:From baseline to week 20.
change from baseline, improvement
Safety / tolerability / PK
1 endpointQuantitative measure of cannabis metabolites
Time frame:From baseline to week 20.
concentration, descriptive
Other clinical outcomes
13 endpointsCannabis consumption
Time frame:From baseline to week 20.
Alcohol consumption, change
change from baseline, improvement
Cannabis consumption
Time frame:From baseline to week 20.
Alcohol consumption, change
change from baseline, improvement
THC consumption
Time frame:From baseline to week 20.
change from baseline, improvement
Severity of cannabis use
Time frame:From baseline to week 20.
AUDIT score
change from baseline, improvement
Cannabis problems
Time frame:From baseline to week 20.
change from baseline, improvement
Cannabis craving
Time frame:From baseline to week 20.
change from baseline, improvement
Severity of alcohol use
Time frame:From baseline to week 20.
AUDIT score
change from baseline, improvement
Severity of drug use
Time frame:From baseline to week 20.
AUDIT score
change from baseline, improvement
Drug use frequency
Time frame:From baseline to week 20.
drug use frequency change
change from baseline, improvement
Severity of nicotine
Time frame:From baseline to week 20.
change from baseline, improvement
Average Daily Cigarette Consumption
Time frame:From baseline to week 20.
Alcohol consumption, change
change from baseline, improvement
Quantitative measure of nicotine intake
Time frame:From baseline to week 20.
change from baseline, improvement
Neural responses in brain regions associated with reward processing
Time frame:From baseline to week 20.
change from baseline, descriptive
Other (unclassified)
2 endpointsFunctional connectivity between NAc/septal regions and prefrontal cortex
Time frame:From baseline to week 20.
change from baseline, descriptive
Functional connectivity between NAc/septal regions and amygdala/insula
Time frame:From baseline to week 20.
change from baseline, descriptive
Publications (1)
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
- Naunyn-Schmiedeberg's archives of pharmacology2026 Jan (month)PMID40682686doi:10.1007/s00210-025-04403-5via pubmed acronym asset candidate
Provenance
Sources
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.