NCT05822830CompletedPhase 3
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 751 (actual)
- First submitted
- 16 Sept 2022
- Start date
- 21 Apr 2023
- Primary completion date
- 13 Nov 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT05822830
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 751
- From 21 Apr 2023 to the primary completion date, 13 Nov 2024
- 32 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in body weight greater than 5 kg within 3 months prior to starting study
Other illness
- Diabetes mellitus
- 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
Who the study is looking for
- Have a body mass index (BMI) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- Have a history of at least 1 unsuccessful dietary effort to lose body weight
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Puerto Rico Medical Research Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| Wellness clinical Research Vega Baja Coordinator of this site? Confirm its status | Vega Baja | Puerto Rico | Unknown status |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Cahaba Research Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| WR-ClinSearch, LLC Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| StudyMetrix Research Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| Dallas Diabetes Research Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| North Texas Endocrine Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Lillestol Research Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Prime Health and Wellness/SKYCRNG Coordinator of this site? Confirm its status | Fayette | United States | Unknown status |
| PharmQuest Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Tribe Clinical Research LLC Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Velocity Clinical Research, Hallandale Beach Coordinator of this site? Confirm its status | Hallandale | United States | Unknown status |
| Biopharma Informatic, LLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| PlanIt Research, PLLC Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Rocky Mountain Clinical Research Coordinator of this site? Confirm its status | Idaho Falls | United States | Unknown status |
| Palm Research Center Sunset Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Palm Research Center Tenaya Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| L-MARC Research Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Southern Endocrinology Associates Coordinator of this site? Confirm its status | Mesquite | United States | Unknown status |
| New Horizon Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Alliance for Multispecialty Research, LLC Coordinator of this site? Confirm its status | Norman | United States | Unknown status |
| Cahaba Research - Pelham Coordinator of this site? Confirm its status | Pelham | United States | Unknown status |
| Pinnacle Clinical Research Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Southern California Dermatology, Inc. Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Encompass Clinical Research Coordinator of this site? Confirm its status | Spring Valley | United States | Unknown status |
| ForCare Clinical Research Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division Coordinator of this site? Confirm its status | Troy | United States | Unknown status |
| University Clinical Investigators, Inc. Coordinator of this site? Confirm its status | Tustin | United States | Unknown status |
| Rophe Adult and Pediatric Medicine/SKYCRNG Coordinator of this site? Confirm its status | Union City | United States | Unknown status |
| Iowa Diabetes and Endocrinology Research Center Coordinator of this site? Confirm its status | West Des Moines | United States | Unknown status |
Related publications
- Tirzepatide compared with semaglutide in obesity disease: a subpopulation analysis applying Japan Society for the Study of Obesity criteria in the global SURMOUNT-5 trial.Curr Med Res Opin · 2026 · PMID 42434924
- Relationship of early rapid weight loss to efficacy and safety of tirzepatide and semaglutide for obesity: SURMOUNT-5 post hoc analysis.Am J Med · 2026 · PMID 41865857
This page is information, not medical advice. Discuss any trial with your doctor.