Status:
WITHDRAWN
Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Eli Lilly and Company
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Obesity
Metabolic Disease
Eligibility:
All Genders
21-65 years
Phase:
PHASE4
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 innovat...
Eligibility Criteria
Inclusion
- Self-reported Hispanic and/or Latino heritage
- Body Mass Index (BMI) 30-42 kg/m²
- HbA1c ≤ 6.4%
Exclusion
- 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
Key Trial Info
Start Date :
September 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06009653
Start Date
September 13 2023
End Date
May 29 2024
Last Update
February 25 2025
Active Locations (1)
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1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105