Rocky Mountain Clinical Research, LLC | Idaho Falls, ID
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About
The main purpose of this study is to evaluate the efficacy and safety of tirzepatide for the maintenance of body weight reduction.
Full description
All enrolled participants will complete a 60-week open-label Weight-Loss Period on tirzepatide maximum tolerated dose (MTD) and upon meeting randomization criteria will enter a 52-week double-blinded Weight Maintenance Period to be assigned to either tirzepatide 5 mg, tirzepatide MTD or placebo.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Have a Body Mass Index (BMI) of ≥30 kilogram/square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight related comorbidities:
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight (BW)
Exclusion criteria
Have Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D), a history of ketoacidosis, or hyperosmolar state or coma.
Have a self-reported change in BW>5 kilogram (kg) within 3 months prior to screening
Have a prior or planned surgical treatment for obesity, excluding liposuction or abdominoplasty if performed >1 year prior to screening.
Have a history of chronic or acute pancreatitis
Have any of the following cardiovascular conditions within 3 months prior to week 0.
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
Primary purpose
Allocation
Interventional model
Masking
400 participants in 3 patient groups, including a placebo group
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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