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Tirzepatide for Obesity and Meth Use Disorder
Tirzepatide for Individuals With Comorbid Obesity and Methamphetamine Use Disorder
Lead sponsor
Asset
Tirzepatide
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
45
estimated
Study population
Alcohol / substance use, Obesity / overweight
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Be 18 to 65 years of age, inclusive.
2. Be able to provide informed consent and ask relevant questions.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Be willing to adhere to the study medication regimen
5. Meet DSM-5 criteria for moderate or severe methamphetamine use disorder.
6. Self-report methamphetamine use on 18 or more days in the 30-day period prior to written informed consent using the Timeline Followback (TLFB).
7. Have an initial body mass index (BMI) at screening of:
1. 30 kg/m2 or greater (obesity)
2. 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea or cardiovascular disease).
8. If biologically female and is or becomes sexually active with a biological male, must agree to use acceptable methods of contraception and have urine pregnancy testing during participation in the study, unless unable to get pregnant
a. Appropriate birth control methods include: i. Oral contraceptives, contraceptive patch, hormonal vaginal contraceptive ring (with restrictions related to dose change given the medication interactions between tirzepatide and oral contraceptives).
9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration
Exclusion criteria
1. Current or recent use (within 3 months prior to consent) of other tirzepatide-containing products or any other GLP-1 receptor agonist
2. Current or recent use (within 30 days) of sulfonylureas, other concomitantly administered insulin secretagogue, or insulin
3. Current or recent use (within 3 months prior to consent) of other weight loss agents
4. Weight loss surgery within 12 months prior to consent
5. Current eating disorder per clinician evaluation
6. Personal or family history of Medullary Thyroid Carcinoma
7. History of Multiple Endocrine Neoplasia syndrome type 2
8. Known serious hypersensitivity (e.g., anaphylaxis, angioedema) to tirzepatide or any of the excipients in tirzepatide
9. History of angioedema or anaphylaxis with a GLP-1 receptor agonist
10. Current Stage 3 or higher Chronic Kidney Disease, defined as eGFR <60 at Screening
11. Current inadequately controlled diabetes, defined as HbA1c > 7.0 at Screening
12. History of diabetic retinopathy
13. Current pregnancy or lactation
14. Treatment with another investigational drug or intervention within the past one month (30 days prior to consent)
15. Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee.
16. Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.
Endpoints (6)
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
1 endpointChanges in body mass index from baseline to the end of the 32-week treatment phase
Time frame:32 weeks
BMI, change
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointChanges in High-sensitivity C-reative protein (hs-CRP) levels from baseline to the end of the 32-week treatment phase
Time frame:32 weeks
hs-CRP, change
change from baseline, improvement
LOINC 30522-7
Patient-reported / QoL
2 endpointsChanges in self-reported symptoms of anhedonia from baseline to the end of the 32-week treatment phase
Time frame:32 weeks
change from baseline, improvement
Changes in gastrointestinal symptom severity from baseline until the end of the 32-week treatment phase
Time frame:32 weeks
change from baseline, improvement
Other clinical outcomes
2 endpointsEffect of tirzepatide on self-reported use of methamphetamine
Time frame:36 weeks
Alcohol consumption, change
descriptive, improvement
Feasibility of using tirzepatide in individuals with Methamphetamine Use Disorder
Time frame:4 weeks
threshold achievement, descriptive
Publications (8)
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
- International journal of obesity (2005)2023 Aug (month)PMID37253796doi:10.1038/s41366-023-01321-5via CT.gov background
- The American journal on addictions2009 Nov-Dec (year)PMID19874165doi:10.3109/10550490903205579via CT.gov background
- Health and quality of life outcomes2008 Jan 31PMID18237386doi:10.1186/1477-7525-6-12via CT.gov background
- Journal of affective disorders2007 Apr (month)PMID16996138doi:10.1016/j.jad.2006.08.020via CT.gov background
- British journal of addiction1988 Apr (month)PMID3395719doi:10.1111/j.1360-0443.1988.tb00485.xvia CT.gov background
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.