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Active not recruitingPhase 2

Tirzepatide for Obesity and Meth Use Disorder

Tirzepatide for Individuals With Comorbid Obesity and Methamphetamine Use Disorder

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

NCT IDNCT06745128
Org study IDSTU-2024-1221

Timeline

Milestones

Study first posted2024-12-20actual
Study start2025-02-03actual
Last update posted2025-06-12actual
Primary completion2026-03-31estimated
Study completion2026-03-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Alcohol / substance useObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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).

ii.Barrier (diaphragm or condom)
iii.Contraceptive implant
iv.Medroxyprogesterone acetate injection
v.Intra-uterine device
vi.Complete abstinence from sexual intercourse
vii.Surgical sterilization

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

Patient-reported / QoL
2
Other clinical outcomes
2
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Changes 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 endpoint
Secondary/protocol endpoint

Changes 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 endpoints
Secondary/protocol endpoint

Changes 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

Secondary/protocol endpoint

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 endpoints
Primary/protocol endpoint/low confidence

Effect of tirzepatide on self-reported use of methamphetamine

Time frame:36 weeks

Alcohol consumption, change

descriptive, improvement

Secondary/protocol endpoint

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

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.