A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Completed · Phase 2

Conditions studied: Type 2 Diabetes Mellitus

In brief

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.

Key facts

Study ID

NCT04450394

Run by

Eli Lilly and Company

People needed

278

Starts

2020-07-01

Expected to finish

2021-10-08

Last updated by the study team

2022-11-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to screening
• Participants must have a HbA1c value of 7.0% to 9.5%, inclusive
• Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive

You may not qualify if…

• Have type 1 diabetes mellitus or latent autoimmune diabetes
• Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
• Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
• Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
• Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m²
• Have active or untreated cancer
• Are receiving chronic (>14 days) systemic glucocorticoid therapy

Where it is running

• National Research Institute - Huntington Park — Huntington Park, California, United States
• National Research Institute - Wilshire — Los Angeles, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Encompass Clinical Research — Spring Valley, California, United States
• CMR of Greater New Haven — Waterbury, Connecticut, United States
• ALL Medical Research, LLC — Cooper City, Florida, United States
• Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States
• Suncoast Research Group — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• Rophe Adult and Pediatric Medicine — Union City, Georgia, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Rocky Mountain Clinical Research — Idaho Falls, Idaho, United States
• Elite Clinical Trials — Rexburg, Idaho, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Cotton O'Neil Diabetes and Endocrinology Center — Topeka, Kansas, United States
• L-MARC Research Center — Louisville, Kentucky, United States
• Endocrine and Metabolic Consultants — Rockville, Maryland, United States
• Sky Clin Resch - Quinn HC — Ridgeland, Mississippi, United States
• Lillestol Research LLC — Fargo, North Dakota, United States
• Intend Research, LLC — Norman, Oklahoma, United States
• Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States
• Holston Medical Group — Bristol, Tennessee, United States
• Texas Diabetes & Endocrinology, P.A. — Austin, Texas, United States
• Syed Research Consultants Llc — Sheffield, Alabama, United States

Full record on ClinicalTrials.gov

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