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

The Washington University

Status and phase: Withdrawn; Phase 4

Conditions: Obesity; Metabolic Disease

Treatments: Behavioral: Standard Care; Behavioral: Culturally-tailored dietary and behavioral intensive lifestyle intervention; Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06009653

P50MD017344 (U.S. NIH Grant/Contract)

202209182

Details and patient eligibility

About

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.

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups

Standard Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard Care

Intensive lifestyle intervention plus placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Behavioral: Culturally-tailored dietary and behavioral intensive lifestyle intervention

Intensive lifestyle intervention plus tirzepatide

Experimental group

Description:

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

Treatment:

Drug: Tirzepatide

Behavioral: Culturally-tailored dietary and behavioral intensive lifestyle intervention