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Tirzepatide + Lifestyle Intervention for Obesity (TRZ Trial)

Phase 4
Recruiting
Led By Miriam Jacome Sosa
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after 52 weeks of intervention
Awards & highlights

TRZ Trial Summary

This trial will study the effects of a drug (tirzepatide) combined with a lifestyle intervention (ILI) to see if it helps Latino adults with obesity.

Who is the study for?
This trial is for Latino adults with obesity (BMI 30-42 kg/m²) who have not been diagnosed with diabetes and do not have severe organ dysfunction, psychiatric disorders, substance abuse issues, or certain cancers. Participants must not be pregnant or breastfeeding and should agree to use contraception.Check my eligibility
What is being tested?
The study tests the effect of a drug called tirzepatide combined with an intensive lifestyle intervention tailored for Latinos on weight loss and metabolic health over a year. It compares standard care, placebo plus lifestyle changes, and tirzepatide plus lifestyle changes.See study design
What are the potential side effects?
Tirzepatide may cause digestive problems like nausea or vomiting, low blood sugar levels if taken without food, increased heart rate, headache, fatigue and possibly allergic reactions at the injection site.

TRZ Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after 52 weeks of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 52 weeks of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in body weight
Secondary outcome measures
Blood pressure
Drug/placebo adherence
Fat mass and fat free mass
+14 more

TRZ Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Intensive lifestyle intervention plus tirzepatideExperimental Treatment2 Interventions
In this arm, participants will receive the behavioral plant-based intervention from community health workers, and will receive subcutaneous injections of tirzepatide weekly during the 52-week intervention
Group II: Intensive lifestyle intervention plus placeboExperimental Treatment2 Interventions
In this arm, participants will receive a culturally-tailored dietary and behavioral intensive lifestyle intervention from community health workers, and will receive placebo subcutaneous injections weekly during the 52-week intervention.
Group III: Standard CareActive Control1 Intervention
In this arm, participants will receive the standard care intervention from community health workers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~5780
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,620 Total Patients Enrolled
8 Trials studying Metabolic Diseases
640 Patients Enrolled for Metabolic Diseases
Eli Lilly and CompanyIndustry Sponsor
2,620 Previous Clinical Trials
3,216,524 Total Patients Enrolled
5 Trials studying Metabolic Diseases
1,161 Patients Enrolled for Metabolic Diseases
National Institute on Minority Health and Health Disparities (NIMHD)NIH
383 Previous Clinical Trials
1,216,284 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any criteria that would disqualify me from participating in this experiment?

"The clinical trial is searching for 75 individuals between the ages of 21 and 65 with a diagnosis of obesity."

Answered by AI

Has the combination of intensive lifestyle intervention and tirzepatide been endorsed by the Federal Drug Administration?

"Safety of Intensive lifestyle intervention plus tirzepatide is rated a 3, as this medication has been approved by the governing body following Phase 4 trials."

Answered by AI

Is there still availability to join this research project?

"The clinical trial is actively recruiting as per the information available on clinicialtrials.gov, which was first published on September 13th 2023 and last edited the day after."

Answered by AI

How many participants have been recruited to this clinical investigation?

"Correct. The clinical trial, which was initially publicized on September 13th 2023, is actively recruiting according to the information found on clinicaltrials.gov. It requires 75 participants from a single medical centre for completion."

Answered by AI

Does this clinical research accept applicants aged 30 or over?

"According to the study's eligibility requirements, participants need to be aged between 21 and 65. Furthermore, there are 237 trials for patients below legal age and 759 experiments that involve those above retirement age."

Answered by AI

Who else is applying?

What site did they apply to?
Sansum Diabetes Research Institute
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’ve struggled all my life with weigh gain, and have only been able to lose weight on extreme diets and very intensive exercise. I gained it back after menopause and being unable to exercise so hard because of osteoarthritis.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
2023. "Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06009653.
~50 spots leftby Aug 2025
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