DelfaGLP-1 Atlas

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Not yet recruitingPhase 2

Tirzepatide for the Treatment of Cannabis Use Disorder

Tirzepatide for the Treatment of Cannabis Use Disorder: A Pilot Double-blind, Placebo-controlled, Crossover Trial

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

0

Recruiting sites

—

Enrollment

6

estimated

Study population

Alcohol / substance use

Key I/E criterion

—

Primary endpoint

•Cue-Induced Craving

Identifiers

Registered as

NCT IDNCT07265752
Org study ID2025P002984

Timeline

Milestones

Study first posted2025-12-05actual
Last update posted2025-12-18actual
Study start2026-07-01estimated
Primary completion2028-06-30estimated
Study completion2028-06-30estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•English speaking adults aged 18 and above
•Diagnosed with DSM-5 cannabis use disorder, severe

Exclusion criteria

•Active psychosis, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
•Any current or lifetime diagnosis of eating disorders including anorexia, bulimia, binge eating or
•Comorbid substance use disorder
•BMI<21 kg/m2
•Current or lifetime diagnosis of Type 1 or Type 2 diabetes
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
•Use of any glucagon-like peptide -1 agonist medications in the prior 3 months
•Anticipating receipt of any glucagon-like peptide-1 agonist medications during the trial
•Current hypoglycemia as indicated by a blood sugar level of <71 mg/dL measured at baseline visit, as well as visits 2 and 4.
•Untreated cholelithiasis or gallbladder disease
•History of acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or congestive heart failure in the last 90 days
•Systolic blood pressure persistently above 160 mmHg or diastolic blood pressure persistently above 100 mmHg during screening
•History of inflammatory bowel disease, bariatric surgery, pancreatitis, diabetic gastroparesis, or non-arteritic anterior ischemic optic neuropathy
•Liver function test greater than 3 times upper normal limit
•Renal impairment as indicated by estimated glomerular filtration rate (eGFR) of <30
•History of hypersensitivity or allergy to tirzepatide
•Pregnant or breastfeeding
•Individuals taking glucagon-like peptide-1 agonists or other weight loss drugs.
•Anticipated to participate in a concurrent drug trial
•Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant

Endpoints (10)

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
3
Glycemic / diabetes
2
Patient-reported / QoL
2
Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight

Time frame:5 weeks

descriptive, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint/low confidence

Blood sugar

Time frame:5 weeks

descriptive, improvement

Secondary/protocol endpoint

Hemoglobin A1c

Time frame:5 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Depression severity as measured by the Patient Health Questionnaire-8 (PHQ-8)

Time frame:5 weeks

change from baseline, improvement

Secondary/protocol endpoint

Anxiety severity as measured by the Generalized Anxiety Disorder-7 scale (GAD-7)

Time frame:5 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Serious adverse event

Time frame:5 weeks

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Suicidality as measured by the C-SSRS (Columbia-Suicide Severity Rating Scale)

Time frame:5 weeks

descriptive, event

Other clinical outcomes

3 endpoints
Primary/protocol endpoint

Cue-Induced Craving

Time frame:5 weeks

change from baseline, improvement

Secondary/protocol endpoint

Cravings

Time frame:5 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Abstinence

Time frame:5 weeks

Alcohol consumption, change

percent change from baseline, 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.