Tirzepatide for Obesity and Methamphetamine Addiction

Overseen By Teresa Slettebo, B.A.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: GLP-1 agonists, Insulin, Sulfonylureas, others

Disqualifiers: Eating disorder, Thyroid carcinoma, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 37

Duration: 32 weeks

45 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial requires that you stop using certain medications, such as other tirzepatide products, GLP-1 receptor agonists, sulfonylureas, insulin, and other weight loss agents, before joining. If you're taking any of these, you may need to stop them for a specific period before participating.

What data supports the effectiveness of the drug tirzepatide for obesity and methamphetamine addiction?

Research shows that tirzepatide, a drug used for type 2 diabetes, helps people lose weight. In studies, people taking tirzepatide lost significantly more weight compared to those taking a placebo (a substance with no active drug). ^{1 2 3 4 5}

Is tirzepatide safe for humans?

Tirzepatide has been studied for weight loss and type 2 diabetes, showing a safety profile similar to other treatments in its class. Common side effects include nausea, vomiting, diarrhea, and constipation, but it generally has a comparable safety profile to other similar medications. ^{1 4 5 6 7}

How is the drug Tirzepatide unique for treating obesity and methamphetamine addiction?

Tirzepatide is unique because it is a 'twincretin', meaning it targets two receptors, GLP-1 and GIP, which helps in significantly reducing body weight and improving insulin sensitivity. It is administered once a week via subcutaneous injection, making it convenient compared to other treatments that may require more frequent dosing. ^{2 3 4 6 8}

What is the purpose of this trial?

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.

Research Team

Manish Jha, M.B.B.S.

Principal Investigator

University of Texas Southwestern Medical Center

Eligibility Criteria

This trial is for adults aged 18-65 with obesity and methamphetamine use disorder, who've used meth on 18+ days in the last month. Participants must agree to lifestyle changes, contraception if applicable, and follow study procedures. Exclusions include certain medical conditions, recent use of similar drugs or weight loss surgery.

Inclusion Criteria

I can understand and ask questions about the study.

Self-report methamphetamine use on 18 or more days in the 30-day period prior to written informed consent using the Timeline Followback (TLFB)

Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria

Have any condition for which study participation would not be in their best interest or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee

I have used insulin or certain diabetes medications in the last 30 days.

Current eating disorder per clinician evaluation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive weekly subcutaneous injections of tirzepatide for a 32-week period

32 weeks

32 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

4 visits (in-person)

Treatment Details

Interventions

• Tirzepatide

Trial Overview The trial tests Tirzepatide's effectiveness for individuals with obesity and meth addiction when prescribed for weight management. It's an open-label pilot study assessing feasibility and preliminary outcomes of this FDA-approved medication in a new patient population.

Participant Groups

Group I: Tirzepatide Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

In a 72-week phase 3 trial involving 938 adults with obesity and type 2 diabetes, tirzepatide (10 mg and 15 mg) led to significant weight loss, with reductions of -12.8% and -14.7% respectively, compared to only -3.2% with placebo.

The safety profile of tirzepatide was generally favorable, with most adverse events being mild to moderate gastrointestinal issues, and serious adverse events were rare, indicating it is a safe option for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Garvey, WT., Frias, JP., Jastreboff, AM., et al.[2023]

Tirzepatide, administered once weekly, has been shown to be effective in promoting weight loss in individuals with obesity, as demonstrated in a clinical study.

The treatment not only aids in weight reduction but also improves metabolic health markers, making it a promising option for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In adults with obesity without diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. Davidson, MB.[2022]

In a study of 579 adults with obesity, tirzepatide significantly enhanced weight loss after a 12-week lifestyle intervention, achieving an average additional weight reduction of 18.4% compared to just 2.5% with placebo over 72 weeks.

The treatment was well-tolerated, with the most common side effects being mild to moderate gastrointestinal issues, indicating that tirzepatide is a safe and effective option for further weight management in individuals who have already lost weight through lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Wadden, TA., Chao, AM., Machineni, S., et al.[2023]

In a 72-week phase 3 trial involving 2539 adults with obesity, tirzepatide (5 mg, 10 mg, or 15 mg) resulted in significant weight loss, with mean reductions of -15.0%, -19.5%, and -20.9% respectively, compared to only -3.1% with placebo.

A high percentage of participants (85% to 91%) on tirzepatide achieved at least a 5% weight reduction, and many experienced improvements in cardiometabolic measures, although gastrointestinal side effects were the most common adverse events, mostly mild to moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. Jastreboff, AM., Aronne, LJ., Ahmad, NN., et al.[2023]

Tirzepatide, a dual receptor agonist for type 2 diabetes, significantly reduces body weight compared to placebo, with an average weight loss of up to 11.8 kg and a percent change in weight of up to -12.4% over 12 to 72 weeks in a meta-analysis of 6 studies involving 4036 participants.

While tirzepatide is effective for weight management, it is associated with a higher incidence of gastrointestinal side effects, such as nausea, vomiting, and diarrhea, particularly at the 15 mg dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the dual GIP and GLP-1 receptor agonist tirzepatide for weight loss: a meta-analysis of randomized controlled trials. de Mesquita, YLL., Pera Calvi, I., Reis Marques, I., et al.[2023]

Tirzepatide, a new GLP-1 receptor agonist, was found to be more effective for weight loss compared to other GLP-1RAs like semaglutide and liraglutide, with significant weight loss observed in over 12,300 patients in the analysis.

While all GLP-1RAs were associated with gastrointestinal side effects, tirzepatide showed better efficacy outcomes for weight loss while maintaining a similar safety profile to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of glucagon-like peptide-1 receptor agonists for the management of obesity in adults without diabetes: A network meta-analysis of randomized clinical trials. Alkhezi, OS., Alahmed, AA., Alfayez, OM., et al.[2023]

In a study involving 117 participants, tirzepatide (15 mg) led to significant weight loss and greater fat mass reduction compared to both placebo and semaglutide (1 mg).

Both tirzepatide and semaglutide effectively reduced appetite compared to placebo, but the differences in energy intake did not fully explain the greater weight loss seen with tirzepatide, suggesting other mechanisms may be at play.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide Reduces Appetite, Energy Intake, and Fat Mass in People With Type 2 Diabetes. Heise, T., DeVries, JH., Urva, S., et al.[2023]

Tirzepatide, a dual GLP-1 and GIP receptor agonist, has been shown to significantly reduce blood sugar levels, improve insulin sensitivity, and lead to over 20% weight loss, making it a promising treatment for obesity and diabetes.

Approved by the FDA in May 2022, tirzepatide offers a convenient once-weekly subcutaneous injection, leveraging its unique design to enhance its effectiveness and provide a new therapeutic option for managing diabetes and related cardiometabolic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide, a New Era of Dual-Targeted Treatment for Diabetes and Obesity: A Mini-Review. Chavda, VP., Ajabiya, J., Teli, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

In adults with obesity without diabetes, adding tirzepatide to a lifestyle intervention increased weight loss at 72 wk. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide Once Weekly for the Treatment of Obesity. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the dual GIP and GLP-1 receptor agonist tirzepatide for weight loss: a meta-analysis of randomized controlled trials. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of glucagon-like peptide-1 receptor agonists for the management of obesity in adults without diabetes: A network meta-analysis of randomized clinical trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide Reduces Appetite, Energy Intake, and Fat Mass in People With Type 2 Diabetes. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Tirzepatide, a New Era of Dual-Targeted Treatment for Diabetes and Obesity: A Mini-Review. [2022]