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Trial · Interventional

CompletedPhase 2Registry data

Tirzepatide for Obesity and Meth Use Disorder

Overview

Status
Completed
Phase
Phase 2
Enrollment
35 participants (actual)
Sponsor
University of Texas Southwestern Medical Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
3 Feb 2025
Primary completion
12 Feb 2026
Completion
12 Feb 2026
First posted
20 Dec 2024
Last update posted
28 Sept 2026
Conditions
Obesity · Methamphetamine Use Disorder

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 2

    Tirzepatide for Obesity and Meth Use Disorder

    NCT06745128

    3 Feb 2025 to 12 Feb 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug

Arms1

  • Experimental

    Tirzepatide

    Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 32-week period in accordance with FDA-prescribing label guidelines.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Effect of tirzepatide on self-reported use of methamphetamine

    Time frame · 36 weeks

    Registry description

    Self-reported use of methamphetamine will be assessed through Timeline Followback. The Timeline Followback procedure will be used to elicit the participant's self-reported use of illicit substances, including but not limited to stimulants, and polysubstance use starting at the Screening Visit and continuing throughout study participation. During the Screening Visit, this form will be used to assess illicit use of substances for the 30-day period prior to written consent. During the study, TLFB will be administered to document the participant's self-reported use of illicit substances, nicotine, and tobacco for each visit since the previous TLFB assessment. Participant's drug of choice will be asked and determined by study coordinator and recorded along with the TLFB assessment.

Secondary outcomes(5)
  1. Feasibility of using tirzepatide in individuals with Methamphetamine Use Disorder

    Time frame · 4 weeks

    Registry description

    Feasibility will be defined as the number of participants who receive a dose of tirzepatide of at least a 5mg/week for at least four weeks.

  2. Changes in body mass index from baseline to the end of the 32-week treatment phase

    Time frame · 32 weeks

    Registry description

    Body mass index will be calculated using measurements of height and weight.

  3. Changes in self-reported symptoms of anhedonia from baseline to the end of the 32-week treatment phase

    Time frame · 32 weeks

    Registry description

    Anhedonia, the inability to experience pleasure, will be assessed by the Snaith-Hamilton Pleasure Scale (SHAPS). The SHAPS questionnaire contains 14 items related to experiencing pleasure over the last several days. Participants are asked to rate their level of agreement or disagreement with each prompt. The scale has a scoring range of 0-14 where a higher point value indicates a higher level of anhedonia.

  4. 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

    Registry description

    Clinical laboratory assessments for High-Sensitivity C-Reactive Protein (HsCRP) test will be performed to help determine eligibility at screening and monitor participant's overall health condition.

  5. Changes in gastrointestinal symptom severity from baseline until the end of the 32-week treatment phase

    Time frame · 32 weeks

    Registry description

    Gastrointestinal symptom severity will be assessed by the Gastrointestinal Symptom Rating Scale (GSRS): a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The GSRS scale is graded on a seven-point Likert-type scale where a lower score (1) represents less symptom severity and highest score (7) represents greater symptom severity.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Observational study · 2025

12 results

Repurposing Semaglutide and Liraglutide for Alcohol Use Disorder.

Lähteenvuo et al. 2025JAMA psychiatrycited by 102

PMID 39535805PMC11561716DOI 10.1001/jamapsychiatry.2024.3599PUB-39535805

CC BY12 results

Indexing hint: Meta-analysis (pooled) · 2023

8 results

Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis.

Tan et al. 2023International journal of obesity (2005)cited by 58

PMID 37253796DOI 10.1038/s41366-023-01321-5PUB-37253796

Full text at the publisher8 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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