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

NCT ID: NCT06009653

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-13
• Study Completion Date: 2024-05-29

Brief 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

Obesity; Metabolic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Standard Care

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

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

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

Intensive lifestyle intervention plus placebo

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 Type: EXPERIMENTAL

Culturally-tailored dietary and behavioral intensive lifestyle intervention

Intervention Type: BEHAVIORAL

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

Placebo

Intervention Type: DRUG

Participants will receive placebo subcutaneous injections.

Intensive lifestyle intervention plus tirzepatide

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 Type: EXPERIMENTAL

Culturally-tailored dietary and behavioral intensive lifestyle intervention

Intervention Type: BEHAVIORAL

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

Tirzepatide

Intervention Type: DRUG

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

Interventions

Standard Care

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Placebo

Participants will receive placebo subcutaneous injections.

Intervention Type: DRUG

Tirzepatide

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Self-reported Hispanic and/or Latino heritage
• Body Mass Index (BMI) 30-42 kg/m²
• HbA1c ≤ 6.4%

Exclusion Criteria

• 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)
• CPAP treatment for obstructive sleep apnea
• Severe cardiovascular disease within the 6 months prior to study enrollment
• Severe organ system dysfunction
• Known clinically significant gastric emptying abnormality
• History of chronic or acute pancreatitis
• Thyroid-stimulating hormone (TSH) >1.5X the upper limit of normal
• Medical conditions that cause obesity
• History of significantly active or unstable Major Depressive Disorder or other severe psychiatric disorder within the last 2 months
• Active substance abuse with alcohol or drugs
• Uncontrolled hypertension
• Liver disease
• Calcitonin level of ≥20 ng/L if eGFR ≥60 mL/min/1.73 m2 or ≥35 ng/L if eGFR <60 mL/min/1.73 m2
• Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
• History of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
• Severe anemia
• Pregnant or breastfeeding
• Metal implants that preclude MRI testing
• Use of medications that are known to affect the study outcome measures
• Do not agree to use contraception throughout the study period in male and female participants of reproductive and childbearing age
• Persons who are not able to grant voluntary informed consent
• Unable or unwilling to follow the study protocol
• Have any other condition not listed in this section (e.g. hypersensitivity or intolerance) that is a contraindication of GLP-1R agonists

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miriam Jacome Sosa

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Countries

United States

Other Identifiers

P50MD017344

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202209182

Identifier Type: -

Identifier Source: org_study_id