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

NCT06009653 | Withdrawn Phase 4 DMC FDA Drug

• 2 other identifiers: 202209182P50MD017344
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Latinos; Obesity; Plant-forward diet; Tirzepatide

Outcome Measures

Primary Outcomes (2)

• Change in body weight

  Percent change in body weight

  After 24 weeks of intervention

• Change in body weight

  Percent change in body weight

  After 52 weeks of intervention

Secondary Outcomes (33)

• Proportion of participants losing at least 5% in body weight

  After 24 weeks of intervention

• Proportion of participants losing at least 5% in body weight

  After 52 weeks of intervention

• Proportion of participants losing at least 10% in body weight

  After 24 weeks of intervention

• Proportion of participants losing at least 10% in body weight

  After 52 weeks of intervention

• Proportion of participants losing at least 15% in body weight

  After 24 weeks of intervention

Study Arms (3)

Standard Care

ACTIVE COMPARATOR

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

Behavioral: Standard Care

Intensive lifestyle intervention plus placebo

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.

Behavioral: Culturally-tailored dietary and behavioral intensive lifestyle intervention; Drug: Placebo

Intensive lifestyle intervention plus tirzepatide

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

Behavioral: Culturally-tailored dietary and behavioral intensive lifestyle intervention; Drug: Tirzepatide

Interventions

Standard Care BEHAVIORAL

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

Standard Care

Culturally-tailored dietary and behavioral intensive lifestyle intervention 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.

Intensive lifestyle intervention plus placebo; Intensive lifestyle intervention plus tirzepatide

Placebo DRUG

Participants will receive placebo subcutaneous injections.

Intensive lifestyle intervention plus placebo

Tirzepatide DRUG

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

Intensive lifestyle intervention plus tirzepatide

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eli Lilly and Company: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases

Interventions

Standard of Care; Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Miriam Jacome Sosa

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 24, 2023
• Study Start: September 13, 2023
• Primary Completion: May 29, 2024
• Study Completion: May 29, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

US (1)