Evaluating Orforglipron for Weight Management in People with Obesity or Overweight
A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes
PHASE3 · Eli Lilly and Company · NCT06993792
This study is testing if orforglipron can help people with obesity or overweight manage their weight better than a placebo, including those with and without type 2 diabetes.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company (industry) |
| Locations | 89 sites (Tucson, Arizona and 88 other locations) |
| Trial ID | NCT06993792 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of orforglipron in individuals with obesity or overweight, both with and without type 2 diabetes. Participants will undergo a screening process lasting about four weeks before being assigned to one of two studies based on their diabetes status. The trial will compare the effects of orforglipron against a placebo to determine its effectiveness in managing weight and related health conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with obesity or overweight, with or without type 2 diabetes.
Not a fit: Patients who are not overweight or do not have obesity may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for weight management in individuals struggling with obesity or overweight, potentially improving their overall health.
How similar studies have performed: Other studies have shown promise in using similar approaches for weight management, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
There are no specific eligibility criteria for the Master Protocol. * See study GZP1 for eligibility criteria relevant to participants with obesity and overweight without type 2 diabetes * See study GZP2 for eligibility criteria relevant to participants with type 2 diabetes
Where this trial is running
Tucson, Arizona and 88 other locations
- Novak Clinical Research - Tucson - North La Cholla Boulevard — Tucson, Arizona, United States (NOT_YET_RECRUITING)
- Norcal Endocrinology & Internal Medicine — San Ramon, California, United States (NOT_YET_RECRUITING)
- Southern California Clinical Research — Santa Ana, California, United States (NOT_YET_RECRUITING)
- Care Access - Thousand Oaks — Thousand Oaks, California, United States (NOT_YET_RECRUITING)
- Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, United States (NOT_YET_RECRUITING)
- Innovation Medical Research Center - Fort Lauderdale — Fort Lauderdale, Florida, United States (NOT_YET_RECRUITING)
- Encore Medical Research — Hollywood, Florida, United States (NOT_YET_RECRUITING)
- West Orange Endocrinology P.A. — Ocoee, Florida, United States (NOT_YET_RECRUITING)
- Care Access - Tampa — Tampa, Florida, United States (NOT_YET_RECRUITING)
- Care Access - Decatur — Decatur, Georgia, United States (NOT_YET_RECRUITING)
- Accel Research Sites - NeuroStudies Clinical Research Unit — Decatur, Georgia, United States (NOT_YET_RECRUITING)
- Javara - Privia Medical Group Georgia - Savannah — Savannah, Georgia, United States (NOT_YET_RECRUITING)
- North Georgia Clinical Research — Woodstock, Georgia, United States (NOT_YET_RECRUITING)
- Solaris Clinical Research — Meridian, Idaho, United States (NOT_YET_RECRUITING)
- Care Access - New Iberia — New Iberia, Louisiana, United States (RECRUITING)
- Endocrine and Metabolic Consultants — Rockville, Maryland, United States (NOT_YET_RECRUITING)
- Javara - Privia Medical Group - Silver Spring — Silver Spring, Maryland, United States (NOT_YET_RECRUITING)
- Boeson Research MSO — Missoula, Montana, United States (NOT_YET_RECRUITING)
- Javara - Nevada Health Centers - Carson City — Carson City, Nevada, United States (NOT_YET_RECRUITING)
- The Machuca Foundation — Las Vegas, Nevada, United States (NOT_YET_RECRUITING)
- University of North Carolina Medical Center — Chapel Hill, North Carolina, United States (NOT_YET_RECRUITING)
- Javara - Tryon Medical Partners — Charlotte, North Carolina, United States (NOT_YET_RECRUITING)
- Care Access - Fayetteville — Fayetteville, North Carolina, United States (NOT_YET_RECRUITING)
- The Corvallis Clinic, P.C. — Corvallis, Oregon, United States (NOT_YET_RECRUITING)
- Clinical Research of Philadelphia — Philadelphia, Pennsylvania, United States (NOT_YET_RECRUITING)
- Frontier Clinical Research, LLC — Smithfield, Pennsylvania, United States (NOT_YET_RECRUITING)
- Velocity Clinical Research, Dallas — Dallas, Texas, United States (NOT_YET_RECRUITING)
- Biopharma Informatic, LLC — Houston, Texas, United States (NOT_YET_RECRUITING)
- Texas Valley Clinical Research (TVCR) - Mission — Mission, Texas, United States (NOT_YET_RECRUITING)
- Consano Clinical Research, LLC — Shavano Park, Texas, United States (RECRUITING)
- CARE - Centro de Alergia y Enfermedades Respiratorias — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina (NOT_YET_RECRUITING)
- CIPREC — Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina (NOT_YET_RECRUITING)
- Centro Médico Viamonte — Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina (NOT_YET_RECRUITING)
- Instituto Centenario — Caba, Ciudad Autónoma De Buenos Aires, Argentina (NOT_YET_RECRUITING)
- Instituto Médico Catamarca IMEC — Rosario, Santa Fe, Argentina (NOT_YET_RECRUITING)
- Centro de Diagnóstico y Rehabilitación (CEDIR) — Santa Fe, Argentina (NOT_YET_RECRUITING)
- The Second People's Hospital of Hefei — Hefei, Anhui, China (NOT_YET_RECRUITING)
- Xuanwu Hospital Capital Medical University — Beijing, Beijing, China (NOT_YET_RECRUITING)
- Peking University Third Hospital — Beijing, Beijing, China (NOT_YET_RECRUITING)
- The Second Affiliated Hospital Chongqing Medical University — Chongqing, Chongqing, China (NOT_YET_RECRUITING)
- Zhujiang Hospital — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
- The Fourth Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (NOT_YET_RECRUITING)
- The First Affiliated Hospital of Henan University of Science &Technology — Luoyang Shi, Henan, China (NOT_YET_RECRUITING)
- Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
- The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
- Jinan Central Hospital — Jinan, Shandong, China (NOT_YET_RECRUITING)
- Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
- The Second Hospital of Tianjin Medical University — Tianjin, Tianjin, China (NOT_YET_RECRUITING)
- MUDr. Alena Vachova — Ceske Budejovice, Jihočeský Kraj, Czechia (NOT_YET_RECRUITING)
- VASOMED Clinic — Ostrava, Moravskoslezský Kraj, Czechia (NOT_YET_RECRUITING)
+39 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Overweight, Type 2 Diabetes