Tirzepatide for Weight Loss in People With HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the use of tirzepatide, a medication, to aid weight loss in people with HIV. It targets adults with well-controlled HIV who are overweight or obese. The study measures weight changes over 12 weeks, along with other health markers such as liver fat and inflammation. This trial may suit individuals with HIV who manage their condition well and also have conditions like high blood pressure or sleep apnea, in addition to being overweight or obese. As a Phase 2 trial, it evaluates tirzepatide's effectiveness in an initial, smaller group, allowing participants to contribute to important research.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it does require that you have been on a stable antiretroviral therapy (ART) for at least one year before joining the study.
Is there any evidence suggesting that tirzepatide is likely to be safe for humans?
Research has shown that tirzepatide is generally safe for patients, but some side effects include nausea, vomiting, diarrhea, and constipation. More real-world safety information about tirzepatide is needed, making ongoing studies crucial for a better understanding of its safety. Although tirzepatide is already approved for other uses, indicating a degree of safety, further studies are necessary to confirm its safety specifically for people living with HIV.12345
Why do researchers think this study treatment might be promising for weight loss in people with HIV?
Tirzepatide is unique because it targets both GLP-1 and GIP receptors, which are hormones involved in regulating insulin and appetite. This dual action may offer more effective weight loss compared to existing options for people with HIV, which typically focus on diet and lifestyle changes or single hormone pathways. Researchers are excited because tirzepatide's mechanism could provide significant weight reduction and improved metabolic health, offering a new avenue of hope for those struggling with weight management in the context of HIV.
What evidence suggests that tirzepatide might be an effective treatment for weight loss in people with HIV?
Research has shown that tirzepatide, the investigational treatment in this trial, can aid in weight loss. In earlier studies, participants with HIV who took tirzepatide lost an average of 10.4 kg, while those who did not take it lost only 1.7 kg. Additionally, 60% of participants with HIV lost at least 5% of their body weight. In another study, those who continued taking tirzepatide lost 25.3% of their weight, compared to 9.9% for those on a placebo. These findings suggest that tirzepatide could be a promising option for weight loss in people with HIV.13567
Are You a Good Fit for This Trial?
This trial is for overweight or obese adults with well-controlled HIV-1 on stable antiretroviral therapy (ART) for at least a year. Participants must have an HIV-1 RNA level below 200 copies/mL for over six months and be diagnosed with obesity-related conditions like dyslipidemia, hypertension, cardiovascular disease, or sleep apnea.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tirzepatide (TZP) with dose escalation every 4 weeks to a final dose of 7.5mg
Follow-up
Participants are monitored for safety and effectiveness after treatment
Biorepository Sample Collection
Blood specimens are collected for future research related to HIV, cardiometabolic diseases, inflammation, and the immune system
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Hawaii
Lead Sponsor