DelfaGLP-1 Atlas

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EXALT

CompletedPhase 2

Does Treatment With GLP-1 Reduce Alcohol Intake in Patients With Alcohol Dependence?

Does Glucagon-like Peptide (GLP-1) Receptor Agonist Stimulation Reduce Alcohol Intake in Patients With Alcohol Dependence?

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

—

Enrollment

152

actual

Study population

Alcohol / substance use, Healthy volunteers

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 IDNCT03232112
Org study IDEXALT study

Timeline

Milestones

Study first posted2017-07-27actual
Study start2017-08-07actual
Primary completion2020-03-15actual
Study completion2020-10-05actual
Last update posted2021-06-04actual

Assets

Investigational agents

ExenatideGLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Alcohol / substance useHealthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Informed oral and written consent
•Diagnosed with alcohol dependence according to the criteria of International Classification of Diseases (ICD) 10, World Health Organization and DSM-5
•Alcohol use disorder identification test (AUDIT) score >15
•Age 18 - 70 years
•Heavy alcohol drinking defined as having alcohol consumption over 60 g of alcohol per day (men) or 48 g of alcohol per day (women) for at least 5 days in the past 30 days prior to inclusion measured by the TLFB method.

Exclusion criteria

•Severe psychiatric disease, defined as a diagnosis of schizophrenia, paranoid psychosis, bipolar dis-order 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
•Present or former diagnosis of type 1 or type 2 diabetes or plasma Haemoglobin A1c (HbA1c ) ≥48 moll/L at inclusion
•Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant within the next 9 months (26 weeks plus three months after discontinuation of Bydureon®) , 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) (33)
•Pregnancy (serum hCG > 3 at inclusion) Impaired hepatic function (liver transaminases >3 times up-per normal limit)
•Impaired renal function (eGFR < 50 ml/min and/or microalbuminuria) Impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase > 2 times upper limit)
•S-triglycerides > 10 mmol/l
•Former medullary thyroid carcinoma (MTC) and/or family history with MTC and/or Multiple Endo-crine 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 dependence including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 1 month prior to inclusion
•Concomitant pharmacotherapy with dopamine active drugs, such as some types of Attention Deficit Hyperactivity Disorder (ADHD) medication (methylphenidate)
•Receiving any investigational drug within the last 3 months
•Use of weight-lowering pharmacotherapy within the preceding 3 month
•Any other active substance use defined as a DUDIT-score > 6 (for men) >2 (for women) and fulfilling the criteria's for dependence of the substance according to the criteria of International Classification of Diseases (ICD) 10 (except nicotine)
•BMI <18.5 kg/m2
•Hypersensitivity to the active substance or to any of the excipients
•Only for patients undergoing brain scans: Contraindications for undergoing an fMRI scan (magnetic implants, pacemaker, claustrophobia etc.). Contraindications for undergoing a SPECT-scan (allergy towards iodine, radiation exposure, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 10 mSv in the last 12 months)
•Unable to speak and/or understand Danish
•Any condition that the investigator feels would interfere with trial participation

Endpoints (21)

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
8
Weight & body composition
2
MASH / liver
2
Cardiometabolic biomarkers
2
Patient-reported / QoL
2
Other (unclassified)
2
Glycemic / diabetes
1
Renal / kidney
1
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Body weight

Time frame:Baseline, 4, 12, 20 and 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:Baseline, 4, 12, 20 and 26 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Plasma-glycemic control parameters

Time frame:Baseline and 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints
Secondary/protocol endpoint

Plasma-gamma-glutamyltransferase (GGT)

Time frame:Baseline and 26 weeks

γ-GT, change

change from baseline, improvement

Secondary/protocol endpoint

Plasma-alanine aminotransferase (ALAT)

Time frame:Baseline and 26 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Kidney function

Time frame:Baseline and 26 weeks (eGFR also at week 12)

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Blood pressure

Time frame:Baseline, 4, 12, 20 and 26 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Pulse

Time frame:Baseline, 4, 12, 20 and 26 weeks

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Short Form Health Survey (SF-36)

Time frame:Baseline and 26 weeks

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Symptom Checklist (SCL-92)

Time frame:Baseline and 26 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Plasma amylase

Time frame:Baseline and 26 weeks

change from baseline, descriptive

Other clinical outcomes

8 endpoints
Primary/protocol endpoint

Heavy drinking days

Time frame:30 days prior to baseline and 30 days prior to final follow up at 26 weeks

Alcohol consumption, change

percent change from baseline, improvement

Secondary/protocol endpoint

Total alcohol consumption

Time frame:30 days prior to baseline and 30 days prior to final follow up at 26 weeks

Alcohol consumption, change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Penn Alcohol Craving Scale (PACS) score

Time frame:Baseline and 26 weeks

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Alcohol Use Disorders Identification Test (AUDIT) score

Time frame:Baseline and 26 weeks

AUDIT score

change from baseline, improvement

Secondary/protocol endpoint

Drug Use Disorders Identification Test (DUDIT) score

Time frame:Baseline and 26 weeks

change from baseline, improvement

Secondary/protocol endpoint

Screen For Cognitive Impairment in Psychiatry (SCIP) test

Time frame:Baseline, 4 weeks and 26 weeks

descriptive

Secondary/protocol endpoint

Plasma-phosphatidylethanol (PEth)

Time frame:Baseline, 4, 12, 20 and 26 weeks

concentration, descriptive

Secondary/protocol endpoint

fMRI (functional magnetic resonance imaging)

Time frame:Baseline and 26 weeks

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint

Blood-mean cell volume

Time frame:Baseline and 26 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Single-photon emission computed tomography (SPECT)

Time frame:Baseline and 26 weeks

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

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.