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

Part of paid clinical trials in Santa Barbara, California.

Sponsor
Washington University School of Medicine
Study ID
NCT06009653
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 13, 2023
Status verified
Feb 2025
Primary completion
May 29, 2024
Completion
May 29, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Care
    In this arm, participants will receive the standard care intervention from community health workers.
  • Experimental: 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.
  • Experimental: 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

Primary Outcome Measure

Change in body weight [ Time Frame: After 24 weeks of intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sansum Diabetes Research InstituteSanta BarbaraCalifornia93105-

Find similar trials in Santa Barbara, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Sansum Diabetes Research Institute· Santa Barbara, CA

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