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Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity

NCT06009653 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-02-25

No results posted yet for this study

Summary

The purpose of this study is to conduct a three-arm 52-week, randomized controlled trial with double blind treatment to evaluate the effects of a drug called tirzepatide in combination with an innovative, culturally-appropriate, intensive lifestyle intervention (ILI) delivered by community health workers (CHWs) in Latino adults with obesity. Participants will be randomized to 1) standard care (SC, n=25); 2) culturally-tailored dietary and behavioral intensive lifestyle intervention (ILI, n=25) provided by CHWs plus placebo; or 3) ILI plus tirzepatide (ILI-TRZ) for 52 weeks to evaluate the intervention's effect on: i) weight loss; ii) clinical efficacy (change in body fat mass, liver fat, intra-abdominal fat mass and intrahepatic triglyceride content, oral glucose tolerance, glycemic control, insulin sensitivity and b-cell function, plasma lipids, blood pressure, sleep duration, quality and behaviors, physical performance scores); iii) adherence and fidelity to the intervention (adherence to the intervention and barriers to long term adherence, quality-of-life, fidelity of the implementation by CHWs, CHW's and study participants' acceptability and satisfaction with the intervention and eating behaviors. Placebo or tirzepatide will be injected subcutaneously in the abdomen or thigh once a week for 12 months.

Conditions

Interventions

BEHAVIORAL

Standard Care

Participants will meet with community health workers to receive general health information through individual check-ins.

BEHAVIORAL

Culturally-tailored dietary and behavioral intensive lifestyle intervention

Participants will meet with community health workers to receive information focused on healthy eating while still adhering to a culturally-tailored plant-forward diet.

DRUG

Placebo

Participants will receive placebo subcutaneous injections.

DRUG

Tirzepatide

Participants will receive subcutaneous injections of tirzepatide that gradually increase up to 15 mg per week.

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Miriam Jacome Sosa · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2024-05-29
Completion
2024-05-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06009653 on ClinicalTrials.gov