DelfaGLP-1 Atlas

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CRAVE

Not yet recruitingPhase 3

Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of a GLP-1 Receptor Agonist Semaglutide in U.S. Veterans With Alcohol Use Disorder

CSP #2041 - Cessation or Reduction of Alcohol Consumption in VEterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of a GLP-1 Receptor Agonist Semaglutide in U.S. Veterans With Alcohol Use Disorder (CRAVE)

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

622

estimated

Study population

Alcohol / substance use

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 IDNCT07218354
Org study ID2041

Timeline

Milestones

Study first posted2025-10-20actual
Last update posted2026-04-15actual
Study start2026-07-01estimated
Primary completion2028-04-28estimated
Study completion2029-05-26estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Veteran.
•WHO risk drinking level of Very High or High in the 30 days prior to screening.
•Current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria) based on semi-structured diagnostic exam.
•Able and willing to provide informed consent.

Exclusion criteria

Medical and Psychiatric:

•Type 1 diabetes.
•Current serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, borderline or antisocial personality disorder, eating disorder).
•Current DSM-5 diagnosis of a SUD (other than moderate-to-severe alcohol, any nicotine, or mild cannabis use disorders).
•At the time of randomization, moderate-to-severe alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol (CIWA-AR) >8).
•BMI <21 kg/m2.
•Unstable body weight defined as >5% change in body weight (documented or self-report; intentional or not) in the 90 days prior to randomization.
•History of acute or chronic pancreatitis.
•History of diabetic ketoacidosis.
•History of proliferative diabetic retinopathy.
•History of ascites, advanced liver fibrosis, compensated cirrhosis with portal hypertension, decompensated cirrhosis, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or hepatocellular carcinoma (HCC).
•History of stage 3 fibrosis or stage 4 cirrhosis from a liver biopsy.
•Presence of gastroparesis.
•History of acute gallbladder disease in the prior 6 months.
•History of advanced fibrosis or cirrhosis, including (but not limited to) transient elastography (liver stiffness) of >12 kPa, FIB-4 2.67, ELF 9.8, MRE 3.63 kPa.
•History of esophageal varices on endoscopy or imaging.
•History of nodular liver, cirrhosis, splenomegaly, varices or splenic venous shunting or collaterals on prior imaging.
•History or acute alcohol hepatitis (by liver biopsy or elevated bilirubin > 1.5 times the upper limit of normal).
•History of primary biliary cholangitis.
•History of primary sclerosing cholangitis.
•History of autoimmune liver disease.
•History of hemochromatosis.
•History of Wilson's disease.
•History of alpha-10 antitrypsin-related liver disease.
•History of drug-induced liver disease.
•Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
•Acute high risk of suicide requiring hospitalization at the time of screening or randomization.
•Medical, psychiatric, behavioral, or logistical conditions which, in the judgment of the Local Site Investigator (LSI) or Sub-Investigator (Sub-I), make it unlikely the participant can participate in or complete the 28-week active phase of the study.
•Recent major cardiovascular event in the 90 days prior to randomization (myocardial infarction, stroke, New York Heart Association class IV heart failure, transient ischemic attack (TIA), or unstable angina.

Laboratory

•Hemoglobin A1c (HbA1c)>10.
•Estimated glomerular filtration rate (eGFR) <30 mL/min.
•Albumin < 3.5 g/dl.
•Aspartate aminotransferase (AST) >3 the Upper Limit of Normal (ULN).
•Alanine aminotransferase (ALT) >3 the ULN.
•Lipase > 2 times the upper limit of normal.
•Alkaline phosphatase > 1.5 times the ULN.
•Total bilirubin > 1.5 times the ULN except with documented Gilbert's syndrome.
•International Normalized Ratio (INR) > 1.3 unless due to anticoagulation therapy.
•Platelet count <150,000/µL unless consistent with baseline and reflects the participant's habitual thrombocyte level, and there was no presence of portal hypertension.
•Hepatitis B surface antigen positive.
•Hepatitis C virus RNA positive - participants treated and cured of hepatitis C must have at least 2 years of negative testing.
•Anti-HIV antibody positive test with uncontrolled or unstable treatment.
•Positive urine drug screen for substances other than cannabis and prescribed medications.
•Positive urine pregnancy test at screening in those considered of childbearing potential.

Concurrent Treatments:

•Current (within the past 30 days) use of pharmacotherapy for AUD (including oral or intramuscular naltrexone, acamprosate, disulfiram, topiramate).
•Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue.
•Current (within the past 30 days) use of the following medications with glucose-lowering properties: GLP-1 analogues; sulfonylurea; insulin and insulin products; dipeptidyl peptidase-4 (DPP-4) inhibitors; sodium-glucose cotransporter-2 (SGLT-2) inhibitors or other medications that may interact with semaglutide.
•Recent changes in dose (within 2 months of randomization) of psychiatric medications (i.e., antidepressants, antianxiety, mood stabilizing).

Other

•Pregnant, actively breastfeeding, or female of childbearing potential who is unwilling to use a highly effective method of contraception as defined by the NIH [67].
•Currently enrolled in another therapeutic or investigational clinical trial.
•Participant is incarcerated.

Endpoints (13)

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
12
Safety / tolerability / PK
1

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events of special interest (Assessing safety and tolerability)

Time frame:From randomization through week 32.

event count, event

Other clinical outcomes

12 endpoints
Primary/protocol endpoint

Two-level reduction in the World Health Organization (WHO) risk drinking level

Time frame:Change from Baseline to Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

Alcohol consumption, change

threshold achievement, improvement

Secondary/protocol endpoint

No heavy drinking days

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

Alcohol consumption, change

threshold achievement, improvement

Secondary/protocol endpoint

Two-level reduction in the World Health Organization (WHO) risk drinking level by Race category

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

Alcohol consumption, change

threshold achievement, improvement

Secondary/protocol endpoint

Two-level reduction in the World Health Organization (WHO) risk drinking level by age category (<65, ≥ 65) at baseline

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

threshold achievement, improvement

Secondary/protocol endpoint

Two-level reduction in the World Health Organization (WHO) risk drinking level by psychiatric comorbidity at baseline

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

threshold achievement, improvement

Secondary/protocol endpoint

Two-level reduction in the World Health Organization (WHO) risk drinking level by presence of other psychiatric treatments (medication and/or psychotherapy) at baseline

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

threshold achievement, improvement

Secondary/protocol endpoint

Two-level reduction in the World Health Organization (WHO) risk drinking level by impulsivity category (low, moderate, high) at baseline.

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

Alcohol consumption, change

threshold achievement, improvement

Secondary/protocol endpoint

No heavy drinking days by Race category

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

Alcohol consumption, change

threshold achievement, improvement

Secondary/protocol endpoint

No heavy drinking days by age category (<65, ≥ 65) at baseline

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

threshold achievement, improvement

Secondary/protocol endpoint

No heavy drinking days by psychiatric comorbidity at baseline

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

Alcohol consumption, change

threshold achievement, improvement

Secondary/protocol endpoint

No heavy drinking days by presence of other psychiatric treatments (medication and/or psychotherapy) at baseline

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

Alcohol consumption, change

threshold achievement, improvement

Secondary/protocol endpoint

No heavy drinking days by impulsivity category (low, moderate, high) at baseline.

Time frame:Weeks 5-28. Includes six repeated measurements every 4 weeks from week 5 to 28.

Alcohol consumption, change

threshold achievement, improvement

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.