A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes
Launched by ELI LILLY AND COMPANY · May 15, 2023
Trial Information
Current as of April 25, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new oral medication called orforglipron, which is being tested for its safety and effectiveness in helping adults who are overweight or have obesity and type 2 diabetes. The goal is to see if taking orforglipron once a day can help participants lose weight compared to a placebo, which is a dummy pill with no active ingredients. The study will last about 77 weeks, and participants will need to visit the study site up to 22 times during this period.
To be eligible for the trial, participants should be adults aged 18 and older with a body mass index (BMI) of 27 or higher, meaning they are considered overweight. They should also have a diagnosis of type 2 diabetes and have tried to lose weight through diet or exercise without success. It's important to note that people with type 1 diabetes, certain serious medical histories, or significant recent weight changes will not be able to participate. Those who join the study can expect regular check-ins and monitoring throughout the trial to track their progress and health while taking the medication.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
- • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
- * Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:
- • either diet/exercise alone or
- • up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).
- Exclusion Criteria:
- • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
- • Have a self-reported change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
- • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laster photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
- • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.
- • Have had a history of chronic or acute pancreatitis.
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brisbane, Queensland, Australia
Box Hill, Victoria, Australia
Charlottesville, Virginia, United States
Portland, Oregon, United States
New Port Richey, Florida, United States
Roswell, Georgia, United States
Baltimore, Maryland, United States
Jacksonville, Florida, United States
Woodstock, Georgia, United States
San Antonio, Texas, United States
Larissa, , Greece
Tustin, California, United States
Harbin, Heilongjiang, China
Nanjing, Jiangsu, China
Shenzhen, Guangdong, China
Tianjin, Tianjin, China
Zhengzhou, Henan, China
Wuxi, Jiangsu, China
Nanchang, Jiangxi, China
Albuquerque, New Mexico, United States
Tacoma, Washington, United States
Beijing, Beijing, China
Haikou, Hainan, China
Meadowbrook, Queensland, Australia
Meridian, Idaho, United States
Melbourne, Victoria, Australia
Luoyang, Henan, China
Camberwell, Victoria, Australia
Albany, New York, United States
Venado Tuerto, Santa Fe, Argentina
Indore, Madhya Pradesh, India
San M. De Tucuman, Tucumán, Argentina
Los Angeles, California, United States
West Des Moines, Iowa, United States
Nanjing, Jiangsu, China
Margate, Florida, United States
Rosario, Santa Fe, Argentina
Escondido, California, United States
Brisbane, Queensland, Australia
Heidelberg West, Victoria, Australia
Saint Peters, Missouri, United States
Las Vegas, Nevada, United States
Jinan, Shandong, China
Montclair, California, United States
Pune, Maharashtra, India
Las Vegas, Nevada, United States
Houston, Texas, United States
Yuma, Arizona, United States
Dallas, Texas, United States
Seongnam, Kyǒnggi Do, Korea, Republic Of
Oldenburg, Schleswig Holstein, Germany
Honolulu, Hawaii, United States
Madurai, Tamil Nadu, India
Huntington Park, California, United States
Kunming, Yunnan, China
Noida, Uttar Pradesh, India
San M. De Tucuman, Tucumán, Argentina
Gyeongsan Si, Kyǒngsangbuk Do, Korea, Republic Of
Botany, New South Wales, Australia
Anand, Gujarat, India
Hefei, Anhui, China
Dalian, Liaoning, China
Essen, Nordrhein Westfalen, Germany
Botany, New South Wales, Australia
Hollywood, Florida, United States
Campinas, São Paulo, Brazil
San Antonio, Texas, United States
Chongqing, Chongqing, China
Friedrichsthal, Saarland, Germany
Nantong, Jiangsu, China
Delhi, , India
Huntington Park, California, United States
Troy, Michigan, United States
Córdoba, , Argentina
Merewether, New South Wales, Australia
Oaklands Park, South Australia, Australia
São Paulo, , Brazil
Krnov, Moravskoslezský Kraj, Czechia
Praha, Praha 4, Czechia
München, Bayern, Germany
Gelnhausen, Hessen, Germany
Pohlheim, Hessen, Germany
Essen, Nordrhein Westfalen, Germany
Münster, Nordrhein Westfalen, Germany
Hohenmölsen, Sachsen Anhalt, Germany
Magdeburg, Sachsen Anhalt, Germany
Leipzig, Sachsen, Germany
Pirna, Sachsen, Germany
Thessaloniki, Thessaloníki, Greece
Larissa, Thessalía, Greece
Mumbai, Maharashtra, India
Knoxville, Tennessee, United States
Red Oak, Texas, United States
Pirna, Sachsen, Germany
Raleigh, North Carolina, United States
Luoyang Shi, Henan, China
Los Angeles, California, United States
Buenos Aires, Ciudad Autónoma De Buenos Aire, Argentina
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Santo André, São Paulo, Brazil
Guaynabo, , Puerto Rico
Thessaloniki, Thessaloníki, Greece
Harbin, Heilongjiang, China
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Denison, Texas, United States
Passo Fundo, Rio Grande Do Sul, Brazil
Albany, New York, United States
Caba, Ciudad Autónoma De Buenos Aire, Argentina
Wonju, Kang Won Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Tianjin, Tianjin, China
Ceske Budejovice, Jihočeský, Czechia
Krnov, Moravskosl, Czechia
Pardubice, , Czechia
Rosario, Santa Fe, Argentina
Münster, Nordrhein , Germany
Praha, Praha 1, Czechia
Praha, Praha 8, Czechia
Pribram, Středočeský Kraj, Czechia
Gelnhausen, , Germany
Mumbai, Maharashtra, India
Portland, Oregon, United States
Hyderabad, Telangana, India
Bayamón, , Puerto Rico
Pardubice V, Pardubice, Czechia
Rosario, Santa Fe, Argentina
San Miguel De Tucumán, Tucumán, Argentina
Buenos Aires, , Argentina
Santa Fe, , Argentina
Melbourne, Victoria, Australia
Joondalup, Western Australia, Australia
český Krumlov, , Czechia
Lübeck, , Germany
Athens, Attikí, Greece
Thessaloniki, Kentrikí Makedonía, Greece
Thessaloniki, Thessaloníki, Greece
Köln, Nordrhein Westfalen, Germany
Lawrenceville, Georgia, United States
Bangalore, Karnataka, India
C.A.B.A., Ciudad Aut, Argentina
Dallas, Texas, United States
Nagpur, Maharashtra, India
Lübeck, Schleswig Holstein, Germany
Ceske Budejovice, Jihočeský Kraj, Czechia
Wonju, Kang Won Do, Korea, Republic Of
Albuquerque, New Mexico, United States
Hohenmölsen, , Germany
Friedrichsthal, Saarland, Germany
Córdoba, , Argentina
Pelham, Alabama, United States
Long Island City, New York, United States
Brasilia, Distrito Federal, Brazil
Pilsen, Plzeň Město, Czechia
Hradec Kralove, , Czechia
Pulheim, Hessen, Germany
Hubli, Karnataka, India
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Joondalup, Western Australia, Australia
Raipur, Chhattisgarh, India
Tucson, Arizona, United States
Joondalup, Western Au, Australia
Goiânia, Goiás, Brazil
Volta Redonda, Rio De Janeiro, Brazil
Marília, São Paulo, Brazil
Jilove U Prahy, Praha Západ, Czechia
Plzen, , Czechia
Wallerfing, Bayern, Germany
Hamburg, , Germany
Thessaloniki, Thessaloníki, Greece
Karamsad, Gujarat, India
Aurangabad, Maharashtra, India
Guaynabo, , Puerto Rico
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
český Krumlov, , Czechia
Desoto, Texas, United States
Köln, Nordrhein Westfalen, Germany
C.A.B.A., Ciudad Autónoma De Buenos Aires, Argentina
Caba, Ciudad Autónoma De Buenos Aires, Argentina
Nanjing, Jiangsu, China
São Paulo, , Brazil
New Delhi, Delhi, India
Bayamón, , Puerto Rico
Thessaloniki, Kentrikí Makedonía, Greece
Thessaloniki, , Greece
Guaynabo, , Puerto Rico
Guaynabo, , Puerto Rico
Hollywood, Florida, United States
Guaynabo, , Puerto Rico
Pohlheim, Hessen, Germany
Hyderabad, Telangana, India
Patients applied
Trial Officials
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported