A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
- Registration Number
- NCT06010004
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.
This study includes 3 periods as follows:
* screening and lead-in period: up to 4 weeks
* treatment period: 52 weeks, including 20 weeks of dose escalation, and
* safety follow-up period: 2 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 399
- Have Type 2 Diabetes (T2D)
- Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening.
- Are of stable weight (±5%) for at least 90 days prior to screening 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 BMI ≥23.0 kilogram/square meter (kg/m²) at screening.
-
Have Type 1 Diabetes (T1D).
-
Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
-
Have New York Heart Association functional classification IV congestive heart failure.
-
Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.
- acute myocardial infarction
- cerebrovascular accident (stroke), or
- hospitalization for congestive heart failure
-
Have acute or chronic hepatitis and pancreatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 1 Orforglipron Participants will receive orforglipron administered orally. Orforglipron Dose 2 Orforglipron Participants will receive orforglipron administered orally. Orforglipron Dose 3 Orforglipron Participants will receive orforglipron administered orally.
- Primary Outcome Measures
Name Time Method Number of Participants with Treatment Emergent Adverse Events (TEAEs) Baseline through Week 52
- Secondary Outcome Measures
Name Time Method Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol) Week 52 Change from Baseline in Body Mass Index (BMI) Baseline, Week 52 Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 52 Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol) Week 52 Change from Baseline in Body Weight Baseline, Week 52 Percentage of Participants who Achieve Weight Loss of ≥15% Week 52 Change from Baseline in Waist Circumference Baseline, Week 52 Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Baseline, Week 52 Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol) Week 52 Percentage of Participants who Achieve Weight Loss of ≥5% Week 52 Change from Baseline in Fasting Serum Glucose Baseline, Week 52 Percentage of Participants who Achieve Weight Loss of ≥10% Week 52
Trial Locations
- Locations (40)
Nakayama Clinic
🇯🇵Nagoya, Aichi, Japan
Shinkashiwa Clinic
🇯🇵Kashiwa, Chiba, Japan
Kashiwa City Hospital
🇯🇵Kashiwa, Chiba, Japan
Tokuyama Clinic
🇯🇵Mihama-ku,Chiba City, Chiba, Japan
Hasegawa Medical Clinic
🇯🇵Chitose, Hokkaido, Japan
Odori Diabetes
🇯🇵Sapporo, Hokkaido, Japan
Matsuda Clinic
🇯🇵Kobe, Hyogo, Japan
Nakamoto Internal Medicine Clinic
🇯🇵Mito, Ibaraki, Japan
MinamiAkatsukaClinic
🇯🇵Mito, Ibaraki, Japan
Taya Clinic Koueikai Medical Corporation
🇯🇵Tsuchiura, Ibaraki, Japan
Nakakinen clinic
🇯🇵Naka, Ibaraki, Japan
Nishiyamadou Keiwa Hospital
🇯🇵Naka, Ibaraki, Japan
Shonan Takai Clinic
🇯🇵Kamakura, Kanagawa, Japan
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
🇯🇵Yamato-shi, Kanagawa, Japan
Takai Internal Medicine Clinic
🇯🇵Kamakura-shi, Kanagawa, Japan
Yokohama Minoru Clinic
🇯🇵Yokohama, Kanagawa, Japan
Shiraiwa Medical Clinic
🇯🇵Kashiwara, Osaka, Japan
Gibo Hepatology Clinic
🇯🇵Matsumoto, Nagano, Japan
Kitada Clinic
🇯🇵Osaka-city, Osaka, Japan
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
OHAMA Diabetes Clinic
🇯🇵Kawaguchi, Saitama, Japan
Seiwa Clinic
🇯🇵Adachi-ku, Tokyo, Japan
The Institute for Adult Disease, Asahi Life Foundation
🇯🇵Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Hachioji Diabetes Clinic
🇯🇵Hachioji-shi, Tokyo, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Heishinkai Medical Group ToCROM Clinic
🇯🇵Shinjuku-ku, Tokyo, Japan
Kanno Naika
🇯🇵Mitaka, Tokyo, Japan
Fujii Clinic
🇯🇵Ube, Yamaguchi, Japan
Tashiro Endocrinology Clinic
🇯🇵Fukuoka, Japan
Jinnouchi Hospital
🇯🇵Kumamoto, Japan
Morinaga Ueno Clinic
🇯🇵Kumamoto, Japan
Abe Clinic
🇯🇵Oita, Japan
Kansai Electric Power Hospital
🇯🇵Osaka, Japan
Steel Memorial Yawata Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
🇯🇵Matsuyama, Ehime, Japan
Medical Corporation Tao Internal Medicine Clinic
🇯🇵Ube, Yamaguchi, Japan
Yokkaichi Diabetes Clinic
🇯🇵Yokkaichi, Mie, Japan
Sugiura Internal Medicine Clinic
🇯🇵Soka, Saitama, Japan
Heiwadai Hospital
🇯🇵Miyazaki, Japan