Clinical trial NCT06009653: Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
Official title: Effect of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Obesity
Metabolic Disease
Keywords: Latinos
Obesity
Plant-forward diet
Tirzepatide
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-08-24
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in body weight
timeFrame: After 24 weeks of intervention
measure: Change in body weight
timeFrame: After 52 weeks of intervention
Secondary outcomes:
measure: Proportion of participants losing at least 5% in body weight
timeFrame: After 24 weeks of intervention
measure: Proportion of participants losing at least 5% in body weight
timeFrame: After 52 weeks of intervention
measure: Proportion of participants losing at least 10% in body weight
timeFrame: After 24 weeks of intervention
measure: Proportion of participants losing at least 10% in body weight
timeFrame: After 52 weeks of intervention
measure: Proportion of participants losing at least 15% in body weight
timeFrame: After 24 weeks of intervention
measure: Proportion of participants losing at least 15% in body weight
timeFrame: After 52 weeks of intervention
measure: Fat mass and fat free mass
timeFrame: Before and after 24 weeks of intervention
measure: Fat mass and fat free mass
timeFrame: Before and after 52 weeks of intervention
measure: β-cell function
timeFrame: Before and after 24 weeks of intervention
measure: β-cell function
timeFrame: Before and after 52 weeks of intervention
measure: Insulin clearance
timeFrame: Before and after 24 weeks of intervention
measure: Insulin clearance
timeFrame: Before and after 52 weeks of intervention
measure: Plasma lipids
timeFrame: Before and after 24 weeks of intervention
measure: Plasma lipids
timeFrame: Before and after 52 weeks of intervention
measure: Blood pressure
timeFrame: Before and after 24 weeks of intervention
measure: Blood pressure
timeFrame: Before and after 52 weeks of intervention
measure: Sleep quality
timeFrame: Before and after 24 weeks of intervention
measure: Sleep quality
timeFrame: Before and after 52 weeks of intervention
measure: Sleep quantity
timeFrame: Before and after 24 weeks of intervention
measure: Sleep quantity
timeFrame: Before and after 52 weeks of intervention
measure: Liver fat
timeFrame: Before and after 24 weeks of intervention
measure: Liver fat
timeFrame: Before and after 52 weeks of intervention
measure: Intra-abdominal fat mass and intrahepatic triglyceride content
timeFrame: Before and after 52 weeks of intervention
measure: Physical performance
timeFrame: Before and after 24 weeks of intervention
measure: Physical performance
timeFrame: Before and after 52 weeks of intervention
measure: Grip strength
timeFrame: Before and after 24 weeks of intervention
measure: Grip strength
timeFrame: Before and after 52 weeks of intervention
measure: Lifestyle program adherence
timeFrame: After 24 weeks of intervention
measure: Lifestyle program adherence
timeFrame: After 52 weeks of intervention
measure: Drug/placebo adherence
timeFrame: After 24 weeks of intervention
measure: Drug/placebo adherence
timeFrame: After 52 weeks of intervention
measure: Program acceptability from community health workers and study participants
timeFrame: After 24 weeks of intervention
measure: Program acceptability from community health workers and study participants
timeFrame: After 52 weeks of intervention
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
Study officials:
affiliation: Washington University School of Medicine
name: Miriam Jacome Sosa
role: PRINCIPAL_INVESTIGATOR
References: