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

Obesity Clinical Trial

— TRZ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009653
• Other study ID #: 202209182
• Status: Recruiting
• Phase: Phase 4
• Start date: September 13, 2023
• Est. completion date: November 2025

Study information

• Verified date: September 2023
• Source: Washington University School of Medicine
• Contact: Miriam Jacome Sosa, PhD
• Phone: (314) 362-4884
• Email: mjacome[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Metabolic Disease
• Metabolic Diseases
• Obesity

Intervention

Behavioral:
• Standard Care
Participants will meet with community health workers to receive general health information through individual check-ins.
• 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.
• Tirzepatide
Participants will receive subcutaneous injections of tirzepatide that gradually increase up to 15 mg per week.

Locations

Country	Name	City	State
United States	Sansum Diabetes Research Institute	Santa Barbara	California

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Eli Lilly and Company, National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Percent change in body weight	After 24 weeks of intervention
Primary	Change in body weight	Percent change in body weight	After 52 weeks of intervention
Secondary	Proportion of participants losing at least 5% in body weight	Proportion of participants in each group that lose at least 5% in body weight	After 24 weeks of intervention
Secondary	Proportion of participants losing at least 5% in body weight	Proportion of participants in each group that lose at least 5% in body weight	After 52 weeks of intervention
Secondary	Proportion of participants losing at least 10% in body weight	Proportion of participants in each group that lose at least 10% in body weight	After 24 weeks of intervention
Secondary	Proportion of participants losing at least 10% in body weight	Proportion of participants in each group that lose at least 10% in body weight	After 52 weeks of intervention
Secondary	Proportion of participants losing at least 15% in body weight	Proportion of participants in each group that lose at least 15% in body weight	After 24 weeks of intervention
Secondary	Proportion of participants losing at least 15% in body weight	Proportion of participants in each group that lose at least 15% in body weight	After 52 weeks of intervention
Secondary	Fat mass and fat free mass	Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)	Before and after 24 weeks of intervention
Secondary	Fat mass and fat free mass	Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA)	Before and after 52 weeks of intervention
Secondary	ß-cell function	ß-cell function will be assessed from a modified 3-hour oral glucose tolerance test	Before and after 24 weeks of intervention
Secondary	ß-cell function	ß-cell function will be assessed from a modified 3-hour oral glucose tolerance test	Before and after 52 weeks of intervention
Secondary	Insulin clearance	Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test	Before and after 24 weeks of intervention
Secondary	Insulin clearance	Insulin clearance will be assessed from a modified 3-hour oral glucose tolerance test	Before and after 52 weeks of intervention
Secondary	Plasma lipids	Fasting plasma lipid profile will be assessed by routine blood tests	Before and after 24 weeks of intervention
Secondary	Plasma lipids	Fasting plasma lipid profile will be assessed by routine blood tests	Before and after 52 weeks of intervention
Secondary	Blood pressure	Systolic and diastolic blood pressure will be measured	Before and after 24 weeks of intervention
Secondary	Blood pressure	Systolic and diastolic blood pressure will be measured	Before and after 52 weeks of intervention
Secondary	Sleep quality	Sleep quality will be assessed by polysomnography.	Before and after 24 weeks of intervention
Secondary	Sleep quality	Sleep quality will be assessed by polysomnography.	Before and after 52 weeks of intervention
Secondary	Sleep quantity	Sleep quantity will be assessed by polysomnography.	Before and after 24 weeks of intervention
Secondary	Sleep quantity	Sleep quantity will be assessed by polysomnography.	Before and after 52 weeks of intervention
Secondary	Liver fat	Liver fat will be assessed by using ultrasound	Before and after 24 weeks of intervention
Secondary	Liver fat	Liver fat will be assessed by using ultrasound	Before and after 52 weeks of intervention
Secondary	Intra-abdominal fat mass and intrahepatic triglyceride content	Intra-abdominal fat mass and intrahepatic triglyceride content will be assessed via magnetic resonance imaging (MRI)	Before and after 52 weeks of intervention
Secondary	Physical performance	Physical performance will be measured as the time in seconds that takes to walk 50 ft and to stand up 5 times from a chair.	Before and after 24 weeks of intervention
Secondary	Physical performance	Physical performance will be measured as the time in seconds that takes to walk 50 ft and to stand up 5 times from a chair.	Before and after 52 weeks of intervention
Secondary	Grip strength	Grip strength will be measured using a hand dynamometer.	Before and after 24 weeks of intervention
Secondary	Grip strength	Grip strength will be measured using a hand dynamometer.	Before and after 52 weeks of intervention
Secondary	Lifestyle program adherence	Number of sessions attended	After 24 weeks of intervention
Secondary	Lifestyle program adherence	Number of sessions attended	After 52 weeks of intervention
Secondary	Drug/placebo adherence	Number of injections received	After 24 weeks of intervention
Secondary	Drug/placebo adherence	Number of injections received	After 52 weeks of intervention
Secondary	Program acceptability from community health workers and study participants	Community health workers' and study participants' perceptions of program acceptability via questionnaire	After 24 weeks of intervention
Secondary	Program acceptability from community health workers and study participants	Community health workers' and study participants' perceptions of program acceptability via questionnaire	After 52 weeks of intervention