Purpose

This is a study of tirzepatide in participants with obesity or overweight. The main purpose is to learn more about how tirzepatide maintains body weight loss. The study has two phases: a lead-in phase in which all participants take tirzepatide and a treatment phase in which participants will either continue tirzepatide or switch to placebo. The study will last about 2 years (25 visits).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide
Tirzepatide administered subcutaneously (SC)
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Placebo Comparator
Placebo
Placebo administered SC
  • Other: Placebo
    Administered SC

Recruiting Locations

MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland 20782
Contact:
301-560-7322

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLilly (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.