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NCT05803421 · ClinicalTrials.gov registry record · Phase 3
A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk
A Phase 3 study of Obesity and Type 2 Diabetes, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 2,749
- Enrollment target
- 20
- Study locations
NCT05803421: Active Phase 3 study of Obesity and Type 2 Diabetes, sponsored by Eli Lilly and Company.
NCT05803421 is a Phase 3 study of Obesity and Type 2 Diabetes that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 2,749 participants, above the 816-participant average among 1,053 other Obesity trials with a reported enrollment target (237% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05803421, a Phase 3 study of Obesity and Type 2 Diabetes, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,749 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.
Primary Outcome
Time to First Occurrence of Any MACE-4 (Myocardial Infarction (MI), Stroke, Hospitalization for Unstable Angina, or Cardiovascular \[CV\] Death)
Conditions Studied
Interventions
- DRUG Orforglipron
- DRUG Insulin Glargine
Study Locations (20)
Arizona
- The Institute for Liver Health - Chandler
- Aventiv Research - Mesa
- Arizona Liver Health - Peoria - Peoria
- Elite Clinical Studies, LLC - Phoenix
- Absolute Clinical Research - Phoenix
- Clinical Research Institute of Arizona (CRI) - Sun City West - Sun City West
- Alliance for Multispecialty Research, LLC - Tempe
- Orange Grove Family Practice - Tucson
California
- Hope Clinical Research, Inc. - Canoga Park
- Valley Clinical Trials, Inc. - Covina
- Neighborhood Healthcare Institute of Health - Escondido
- Valley Research - Fresno
- Orange County Research Center - Lake Forest
- Ark Clinical Research - Long Beach
- Pacific Clinical Studies - Los Alamitos
Alabama
- Alliance for Multispecialty Research, LLC - Daphne
- Alliance for Multispecialty Research, LLC - Mobile
- Cahaba Research - Pelham - Pelham
- Syed Research Consultants Llc - Sheffield
Arkansas
- KLR Business Group, Inc. dba Arkansas Clinical Research - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,749 participants |
| Start Date | 2023-04-03 |
| Est. Completion | 2026-03 |
| Phase | Phase 3 |
What the registry record for NCT05803421 still lists
NCT05803421 is an interventional study that assigns participants to a tested intervention. Its 2,749 participants enrollment target places it among the larger protocols in the corpus, above the 816-participant average among 1,053 other Obesity trials with a reported enrollment target (237% higher).
The record links to 6 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Orforglipron is the first listed.
NCT05803421 names 20 study sites across 4 states, led by Arizona, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT05803421 about?
NCT05803421 is a clinical study titled "A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk". The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.
What is the current status of trial NCT05803421?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,749 participants. The study started on 2023-04-03. Estimated completion is 2026-03.
What conditions does trial NCT05803421 study?
This clinical trial studies the following conditions: Obesity, Type 2 Diabetes, Cardiovascular Diseases, Overweight, Chronic Kidney Disease.
What interventions are being tested in trial NCT05803421?
The interventions under investigation include: Orforglipron (DRUG), Insulin Glargine (DRUG).
Who is sponsoring clinical trial NCT05803421?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05803421 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. 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 NCT05803421's enrollment target sits among peer trials
2,749 37th of 1053 higher than 1,017 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
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