Status:
COMPLETED
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
Lead Sponsor:
Eli Lilly and Company
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in ph...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- History of at least one unsuccessful dietary effort to lose body weight
Exclusion
- Diabetes mellitus
- Change in body weight greater than 5 kg within 3 months prior to starting study
- Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
- Any lifetime history of a suicide attempt
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2023
Estimated Enrollment :
783 Patients enrolled
Trial Details
Trial ID
NCT04660643
Start Date
March 29 2021
End Date
May 18 2023
Last Update
May 22 2024
Active Locations (70)
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1
Cahaba Research
Pelham, Alabama, United States, 35124
2
Scripps Memorial Hospital La Jolla
La Jolla, California, United States, 92037
3
National Research Institute - Wilshire
Los Angeles, California, United States, 90057
4
National Research Institute
Panorama City, California, United States, 91402