A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
- Registration Number
- NCT06109311
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 520
-
Have Type 2 Diabetes (T2D)
-
Have HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]
-
Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:
- insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
- insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
- metformin, or
- SGLT-2 inhibitor, or
- both metformin and SGLT-2 inhibitor.
-
Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
-
Have a Body Mass Index (BMI) ≥23.0 kg/m^2 at baseline.
-
Have New York Heart Association functional classification III-IV congestive heart failure.
-
Have had any of the following cardiovascular conditions within 60 days prior to baseline.
- acute myocardial infarction
- cerebrovascular accident (stroke), or
- hospitalization for congestive heart failure.
-
Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
-
Have had chronic or acute pancreatitis any time.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 2 Orforglipron Participants will receive orforglipron orally. Orforglipron Dose 1 Orforglipron Participants will receive orforglipron orally. Orforglipron Dose 3 Orforglipron Participants will receive orforglipron orally. Placebo Placebo Participants will receive placebo orally.
- Primary Outcome Measures
Name Time Method Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40
- Secondary Outcome Measures
Name Time Method Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol Baseline, Week 40 Change from Baseline in Body Weight Baseline, Week 40 Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol)) Baseline to Week 40 Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol) Baseline to Week 40 Percentage Change from Baseline in Body Weight Baseline, Week 40 Percentage of Participants Who Achieved Weight Loss of ≥10% Baseline to Week 40 Orforglipron Dose 3: Change from Baseline in HbA1c Baseline, Week 40 Change from Baseline in Fasting Serum Glucose Baseline, Week 40 Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline Baseline to Week 40 Percentage Change from Baseline in Triglycerides Baseline, Week 40 Change from Baseline in Systolic Blood Pressure Baseline, Week 40 Change from Baseline in Daily Insulin Glargine Dose Baseline, Week 40 Percentage of Participants Who Achieved Weight Loss of ≥5% Baseline to Week 40 Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores Baseline, Week 40
Trial Locations
- Locations (70)
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Texas Valley Clinical Research
🇺🇸Weslaco, Texas, United States
L2IP - Instituto de Pesquisas Clínicas
🇧🇷Brasília, Distrito Federal, Brazil
CEDOES
🇧🇷Vitória, Espírito Santo, Brazil
Quanta Diagnóstico e Terapia
🇧🇷Curitiba, Paraná, Brazil
Insight Centro de Pesquisas
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Pesquisa Sao Lucas
🇧🇷Campinas, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clinicos
🇧🇷Sao Bernardo do Campo, São Paulo, Brazil
ISPEM - Instituto São José dos Campos em Pesquisas Médicas
🇧🇷São José dos Campos, São Paulo, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
🇧🇷Rio de Janeiro, Brazil
CPQuali Pesquisa Clínica
🇧🇷São Paulo, Brazil
The Second People's Hospital of Hefei
🇨🇳Hefei, Anhui, China
Wannan Medical College Yijishan Hospital
🇨🇳Wuhu, Anhui, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Chongqing General Hospital
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang Shi, Henan, China
The Second Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Tokuyama Clinic
🇯🇵Mihama-ku,Chiba City, Chiba, Japan
Hasegawa Medical Clinic
🇯🇵Chitose, Hokkaido, Japan
MinamiAkatsukaClinic
🇯🇵Mito, Ibaraki, Japan
Matoba Internal Medicine Clinic
🇯🇵Ebina, Kanagawa, Japan
Takai Internal Medicine Clinic
🇯🇵Kamakura-shi, Kanagawa, Japan
Shiraiwa Medical Clinic
🇯🇵Kashiwara, Osaka, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
The Institute of Medical Science, Asahi Life Foundation
🇯🇵Chuo-ku, Tokyo, Japan
Jinnouchi Hospital
🇯🇵Kumamoto, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Medical Corporation Sato Medical clinic
🇯🇵Ootaku, Tokyo, Japan
Tama Center Clinic Mirai
🇯🇵Tama, Tokyo, Japan
Abe Clinic
🇯🇵Oita, Japan
Kansai Electric Power Hospital
🇯🇵Osaka, Japan
Centro de Endocrinologia y Nutricion
🇵🇷Caguas, Puerto Rico
FDI Clinical Research
🇵🇷San Juan, Puerto Rico
Diabdana
🇷🇴Oradea, Bihor, Romania
C.M.D.T.A. Neomed
🇷🇴Brasov, Brașov, Romania
Geea Medical Easy Diet
🇷🇴Bucharest, București, Romania
Centrul Medical NutriLife
🇷🇴Bucharest, București, Romania
Centrul Medical Endocrinologie si Diabet Dr. Paveliu
🇷🇴Bucharest, București, Romania
CMI DNBM Dr. Pop Lavinia
🇷🇴Baia Mare, Maramureș, Romania
SC Dentosim Queen SRL - Centrul Medical Diamed
🇷🇴Târgu Mureș, Mureș, Romania
Milena Sante
🇷🇴Galați, Romania
Diamed Obesity
🇷🇴Galați, Romania
Clinica Korall
🇷🇴Satu Mare, Romania
MD First Research - Chandler
🇺🇸Chandler, Arizona, United States
Phoenix Clinical LLC
🇺🇸Phoenix, Arizona, United States
SanRo Clinical Research Group
🇺🇸Bryant, Arkansas, United States
Velocity Clinical Research, Gardena
🇺🇸Gardena, California, United States
Loma Linda University Health System
🇺🇸Loma Linda, California, United States
Western University of Health Sciences
🇺🇸Pomona, California, United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
🇺🇸Toluca Lake, California, United States
CMR of Greater New Haven, LLC
🇺🇸Hamden, Connecticut, United States
Care Access - Brandon
🇺🇸Brandon, Florida, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Encore Medical Research - Weston
🇺🇸Weston, Florida, United States
Orita Clinical Research
🇺🇸Decatur, Georgia, United States
Bingham Memorial Hospital
🇺🇸Blackfoot, Idaho, United States
St. Luke's Humphreys Diabetes Center: Boise
🇺🇸Boise, Idaho, United States
Cotton O'Neil Diabetes & Endocrinology
🇺🇸Topeka, Kansas, United States
Clinvest Headlands Llc
🇺🇸Springfield, Missouri, United States
The Research Group of Lexington
🇺🇸Lexington, Kentucky, United States
Richmond University Medical Center
🇺🇸Staten Island, New York, United States
Velocity Clinical Research, Mt. Auburn
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research, Medford
🇺🇸Medford, Oregon, United States
Tristar Clinical Investigations
🇺🇸Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC
🇺🇸Scottdale, Pennsylvania, United States
Lifedoc Research - Lenox Park Drive
🇺🇸Memphis, Tennessee, United States