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NCT05869903 · ClinicalTrials.gov registry record · Phase 3
A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
A Phase 3 study of Obesity and Overweight, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 3,127
- Enrollment target
- 20
- Study locations
NCT05869903: Active Phase 3 study of Obesity and Overweight, sponsored by Eli Lilly and Company.
NCT05869903 is a Phase 3 study of Obesity and Overweight that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 3,127 participants, above the 816-participant average among 1,053 other Obesity trials with a reported enrollment target (283% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05869903, a Phase 3 study of Obesity and Overweight, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,127 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.
Primary Outcome
Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Orforglipron
Study Locations (20)
California
- John Muir Physician Network Research Center - Concord
- AMCR Institute - Escondido
- NorCal Medical Research, Inc - Greenbrae
- Velocity Clinical Research, Huntington Park - Huntington Park
- Velocity Clinical Research, Westlake - Los Angeles
- Catalina Research Institute, LLC - Montclair
- Norcal Endocrinology & Internal Medicine - San Ramon
- University Clinical Investigators, Inc. - Tustin
Florida
- New Age Medical Research Corporation - Miami
- South Broward Research - Miramar
- Renstar Medical Research - Ocala
- Jedidiah Clinical Research - Tampa - Bay Plaza - Tampa
- Clinical Site Partners, LLC dba Flourish Research - Winter Park
Georgia
- Physicians Research Associates - Lawrenceville
- East Coast Institute for Research, LLC - Macon
- Rophe Adult and Pediatric Medicine/SKYCRNG - Union City
Arizona
- The Institute for Liver Health II dba Arizona Clinical Trials - Mesa - Chandler
- Clinical Research Institute of Arizona (CRI) - Sun City West - Sun City West
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Hawaii
- East-West Medical Research Institute - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,127 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
What the registry record for NCT05869903 still lists
NCT05869903 is an interventional study that assigns participants to a tested intervention. Its 3,127 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 (283% higher).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05869903 names 20 study sites across 6 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT05869903 about?
NCT05869903 is a clinical study titled "A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities". This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with predia...
What is the current status of trial NCT05869903?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 3,127 participants. The study started on 2023-06-05. Estimated completion is 2027-10.
What conditions does trial NCT05869903 study?
This clinical trial studies the following conditions: Obesity, Overweight, Overweight or Obesity.
What interventions are being tested in trial NCT05869903?
The interventions under investigation include: Placebo (DRUG), Orforglipron (DRUG).
Who is sponsoring clinical trial NCT05869903?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05869903 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. 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 NCT05869903's enrollment target sits among peer trials
3,127 35th of 1053 higher than 1,019 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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