Tirzepatide for Obesity and Meth Use Disorder

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 theduration 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 towritten informed consent using the Timeline Followback (TLFB).

7. Have an initial body mass index (BMI) at screening of:

8. 30 kg/m2 or greater (obesity)

9. 27 kg/m2 or greater (overweight) in the presence of at least one weight-relatedcomorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus,obstructive sleep apnea or cardiovascular disease).

10. If biologically female and is or becomes sexually active with a biological male,must agree to use acceptable methods of contraception and have urine pregnancytesting during participation in the study, unless unable to get pregnant a. Appropriate birth control methods include: i. Oral contraceptives, contraceptivepatch, hormonal vaginal contraceptive ring (with restrictions related to dose changegiven the medication interactions between tirzepatide and oral contraceptives). ii. Barrier (diaphragm or condom) iii. Contraceptive implant iv. Medroxyprogesteroneacetate injection v. Intra-uterine device vi. Complete abstinence from sexualintercourse vii. Surgical sterilization

11. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout studyduration

Exclusion Criteria:

1. Current or recent use (within 3 months prior to consent) of othertirzepatide-containing products or any other GLP-1 receptor agonist

2. Current or recent use (within 30 days) of sulfonylureas, other concomitantlyadministered 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 anyof 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 onemonth (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-specifiedassessments, in the opinion of the investigator or their designee.

16. Require immediate hospitalization for psychiatric disorder or suicidal risk asassessed by a licensed study clinician.