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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of tirzepatide for individuals dealing with both obesity and methamphetamine addiction. The research examines whether this medication, already approved for weight-related issues, can also aid in treating methamphetamine use disorder. Participants will receive weekly injections for 32 weeks to test this theory. Individuals who frequently struggle with methamphetamine use and have a body mass index (BMI) indicating obesity or being overweight, along with related health issues like high blood pressure or diabetes, might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide, an FDA-approved treatment for weight issues, is generally well-tolerated. In studies involving individuals with obesity, tirzepatide proved effective and relatively safe. Participants experienced some side effects, usually mild, such as nausea, diarrhea, and reduced appetite, while serious side effects were rare.

Another study examining real-world use found that while unwanted effects occur, they are uncommon. This finding suggests that tirzepatide could be a safe option for managing weight, even for those with other health issues like methamphetamine use disorder.

Overall, tirzepatide maintains a strong safety record, with most individuals tolerating it well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tirzepatide is unique because it targets both obesity and methamphetamine addiction, unlike most treatments that address just one of these issues. This drug works by combining the effects of two hormones, GLP-1 and GIP, which help regulate appetite and insulin levels, offering a novel mechanism compared to traditional weight loss drugs that typically focus on just suppressing appetite. Additionally, its once-weekly injection format provides convenience over daily medications, potentially improving adherence and outcomes for patients. Researchers are excited about tirzepatide because it represents a comprehensive approach to tackling these challenging conditions simultaneously.

What evidence suggests that tirzepatide might be an effective treatment for obesity and methamphetamine addiction?

Research has shown that tirzepatide, the treatment under study in this trial, aids in weight loss. In one study, participants taking tirzepatide lost between 14.9% and 20.9% of their body weight, significantly more than those taking a placebo. Another study found a 12.9% weight loss after six months of using tirzepatide. In addition to promoting weight loss, tirzepatide improved metabolic health markers in overweight individuals. While its effects on methamphetamine addiction remain under investigation, evidence strongly supports its benefits for weight loss. ^{1 4 6 7 8}

Who Is on the Research Team?

Manish Jha, M.B.B.S.

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

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

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

I can understand and ask questions about the study.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06745128

Tirzepatide for Obesity and Meth Use Disorder 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 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2206038

Tirzepatide Once Weekly for the Treatment of Obesity At 20 weeks after randomization, treatment with tirzepatide resulted in a significantly greater weight reduction than that with placebo (Table ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S126236362500031X

Real-world use and effectiveness of tirzepatide among ... In the current study, individuals who persisted on tirzepatide for 6 months experienced mean weight reduction of 12.9 % at 6 months post-index, although most ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11576767/

Efficacy and safety of tirzepatide versus placebo in ... Tirzepatide significantly reduced weight and improved metabolic markers among overweight or obese without diabetes.

5. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2831205

Lifetime Health Effects and Cost-Effectiveness of ... Clinical trials of semaglutide and tirzepatide have shown substantial mean reductions in body weight (14.9% and 20.9%, respectively, compared with placebo) and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469573/

Real-World Safety Concerns of Tirzepatide Despite its efficacy, real-world safety data remain limited. This study analyzed post-marketing adverse events (AEs) associated with tirzepatide ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0033062024001798

Tirzepatide and semaglutide for treating obesity-related ... Tirzepatide and semaglutide, unlike prior weight-loss drugs, are effective and relatively safe/well-tolerated medications that improve nearly all the negative ...

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2812936

Continued Treatment With Tirzepatide for Maintenance of ... This randomized clinical trial examines the effect of tirzepatide on the maintenance of weight reduction.