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ACTIVE NOT RECRUITING
NCT06745128
PHASE2

Tirzepatide for Obesity and Meth Use Disorder

Sponsor: University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

Summary

This is an open-label pilot study to evaluate the feasibility and preliminary efficacy of using tirzepatide when prescribed for its United States (US) Food and Drug Administration (FDA)-approved weight-related indication in individuals with comorbid methamphetamine use disorder.

Official title: Tirzepatide for Individuals With Comorbid Obesity and Methamphetamine Use Disorder

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-02-03

Completion Date

2026-03-31

Last Updated

2025-06-12

Healthy Volunteers

No

Interventions

DRUG

Tirzepatide

Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 32-week period. Following the instructions of the FDA-approved prescribing label, participants or a licensed study clinician will administer the tirzepatide injection subcutaneously in either the abdomen, thigh, or upper arm once weekly for 32 weeks total. Following the instructions of the FDA-approved prescribing label, the dosing schedule will include a 4-week titration at a starting dosage of 2.5mg/week. After four weeks, dosage will be increased in 2.5mg increments. The recommended maintenance dosages per prescribing label are 5mg/week, 10mg/week, or 15mg/week injected subcutaneously. Maximum dosage (up to 15mg/week) will be optimized for each individual. We will use commercially available tirzepatide, primarily dispensed as ZEPBOUND® for this study, but in the event of medication shortage or other pharmacy-related issue, MOUNJARO® may be dispensed as an alternative.

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States