Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04657016 · ClinicalTrials.gov registry record · Phase 3
A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program
A Phase 3 study of Obesity and Overweight, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 579
- Enrollment target
- 20
- Study locations
NCT04657016: Completed Phase 3 study of Obesity and Overweight, sponsored by Eli Lilly and Company.
NCT04657016 is a Phase 3 study of Obesity and Overweight that has completed, run by Eli Lilly and Company. The registered enrollment target is 579 participants, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04657016, a Phase 3 study of Obesity and Overweight, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 579 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).
Primary Outcome
Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).
Conditions Studied
Interventions
- DRUG Tirzepatide
- OTHER Placebo
Study Locations (20)
California
- National Research Institute - Huntington Park - Huntington Park
- National Research Institute - Wilshire - Los Angeles
- Catalina Research Institute, LLC - Montclair
- National Research Institute (NRI) - Santa Ana - Santa Ana
- Encompass Clinical Research - Spring Valley
- Diablo Clinical Research, Inc. - Walnut Creek
Florida
- Clinical Research of South Florida - Coral Gables
- New Horizon Research Center - Miami
- Precision Clinical Research - Sunrise
- Clinical Research of West Florida - Tampa
- Metabolic Research Institute, Inc. - West Palm Beach
Idaho
- Elite Clinical Trials - Blackfoot
- Solaris Clinical Research - Meridian
- Elite Clinical Trials - Rexburg
Indiana
- American Health Network of IN, LLC - Avon
- American Health Network of IN, LLC - Franklin
- American Health Network of IN, LLC - Muncie
Connecticut
- Chase Medical Research, LLC - Waterbury
Illinois
- Evanston Premier Healthcare Research LLC - Evanston
Kansas
- Cotton O'Neil Mulvane - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 579 participants |
| Start Date | 2021-03-29 |
| Est. Completion | 2023-05-12 |
| Phase | Phase 3 |
What the finished NCT04657016 record still lists
NCT04657016 is an interventional study that assigns participants to a tested intervention. The registered 579 participants enrollment target is mid-sized for trials with a published cap, below the 818-participant average among 1,053 other Obesity trials with a reported enrollment target (29% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Tirzepatide is the first listed.
NCT04657016 names 20 study sites across 7 states, led by California, Florida, Idaho.
Frequently Asked Questions
What is clinical trial NCT04657016 about?
NCT04657016 is a clinical study titled "A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program". This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).
What is the current status of trial NCT04657016?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 579 participants. The study started on 2021-03-29. Estimated completion is 2023-05-12.
What conditions does trial NCT04657016 study?
This clinical trial studies the following conditions: Obesity, Overweight.
What interventions are being tested in trial NCT04657016?
The interventions under investigation include: Tirzepatide (DRUG), Placebo (OTHER).
Who is sponsoring clinical trial NCT04657016?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04657016 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04657016's enrollment target sits among peer trials
579 123rd of 1053 higher than 931 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
RECRUITING · Phase 3
-
Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
RECRUITING · Phase 3
-
A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight
RECRUITING · Phase 3
-
A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes
RECRUITING · Phase 3
-
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
RECRUITING · Phase 3
-
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04575935 · 580 participants · Phase 3
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
- NCT05143177 · 580 participants · Phase 2
A Study to Evaluate the Efficacy and Safety of DA-1229 (Evogliptin) in Patient's Calcific Aortic Valve Disease With Mild to Moderate Aortic Stenosis (EVOID-AS)
- NCT05696353 · 580 participants · Phase 3
Teen Driving Translation Study (NIH)
- NCT06578104 · 580 participants
PULSED AF Post-Approval Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI