Suspended

TRZTirzepatide and Intensive Lifestyle Intervention for Weight Loss and Metabolic Health in Latinos with Obesity

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Study Aim

This study aims to evaluate the effectiveness of Tirzepatide combined with an intensive lifestyle intervention for weight loss and metabolic health improvement in Latinos with obesity, primarily focusing on changes in body weight.

What is being tested

Standard Care

+ Culturally-tailored dietary and behavioral intensive lifestyle intervention

+ Placebo

BehavioralDrug
Who is being recruted

Body Weight+6

+ Metabolic Diseases

+ Nutrition Disorders

From 21 to 65 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2023
See protocol details

Summary

Principal SponsorWashington University School of Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 13, 2023

Actual date on which the first participant was enrolled.

This study is focused on understanding how a drug called tirzepatide, combined with a special lifestyle program, affects weight and metabolic health in Latino adults who have obesity. The study aims to see if this combination can improve aspects of health like body fat, blood sugar levels, and overall physical performance. It also examines how well participants follow the program and any challenges they face in sticking to it. This research is important because it specifically tailors the lifestyle program to be culturally relevant, potentially making it more effective and acceptable for the Latino community. Participants in the study are divided into three groups: one receiving standard care, another receiving a lifestyle program plus a placebo, and the last group receiving the lifestyle program plus tirzepatide. The treatment, whether placebo or tirzepatide, is given as a weekly injection in the abdomen or thigh for a year. The study measures outcomes like weight loss and improvements in metabolic health, as well as how well participants adhere to the program. The study also gathers feedback on how participants and community health workers perceive the program and its implementation. This approach helps researchers understand the effectiveness and practicality of the treatment and its delivery.

Official TitleEffect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
NCT06009653
Principal SponsorWashington University School of Medicine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionOverweight

Criteria

3 inclusion criteria required to participate
Self-reported Hispanic and/or Latino heritage
Body Mass Index (BMI) 30-42 kg/m²
HbA1c ≤ 6.4%
24 exclusion criteria prevent from participating
Known clinically significant gastric emptying abnormality
Severe organ system dysfunction
Previous diagnosis of diabetes or fasting glucose ≥ 126 mg/dl or 2 hr oral glucose tolerance test plasma glucose ≥ 200 mg/dl
Unstable weight (≥4% during the last 2 months prior to study enrollment)
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
In this arm, participants will receive the standard care intervention from community health workers.

Group II

Experimental
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

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Sansum Diabetes Research Institute

Santa Barbara, United StatesOpen Sansum Diabetes Research Institute in Google Maps
SuspendedOne Study Center