A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia

Launched by ELI LILLY AND COMPANY · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called retatrutide, which is given once a week, to see how it helps people with Type 2 diabetes recover from low blood sugar (hypoglycemia). The study will last for 16 weeks and aims to compare the effects of retatrutide to a placebo (a harmless substance with no active ingredients) on how quickly participants recover from hypoglycemia.

To join the study, participants need to be diagnosed with Type 2 diabetes for at least six months and currently be following a treatment plan that includes diet, exercise, and a stable dose of metformin (a common diabetes medication) with or without other approved medications. Eligible participants should also have a body mass index (BMI) between 25 and 45 and a stable body weight for the past three months. It's important to note that some people, like those with Type 1 diabetes or recent severe low blood sugar episodes, won't be able to participate. Those who join can expect to receive regular check-ups and guidance throughout the study to ensure their health and safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have been diagnosed with T2DM for at least 6 months prior to screening.
• • Treated with diet and exercise and stable treatment with metformin with or without allowed oral antihyperglycemic medications (OAMs), 3 months prior to screening.
• • Treatment with metformin will be considered stable if all prescribed total daily doses for this period were ±850 mg from the original prescription for the same participant.
• • Allowed OAMs include dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose co-transporter-2 (SGLT2) inhibitors, glinides, or sulfonylureas.
• • Have a hemoglobin A1c value at screening of
• • ≥6.5% and ≤9.5% if on metformin only or
• • ≥6.0% and ≤8.5% if on metformin in combination with allowed OAMs.
• • Have a BMI within the range 25.0 kg/m2 and 45.0 kg/m2 kg/m2 (both inclusive).
• • Have had a stable body weight that is less than 5% change in body weight for more than 3 months prior to screening.
• Exclusion Criteria:
• • Have Type 1 diabetes mellitus.
• • Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
• • Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within the 6 months prior to screening.
• • Have impaired renal estimated glomerular filtration rate \<60 mL/min/1.73 m2 calculated by Chronic Kidney Disease-Epidemiology.
• • Have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis.
• • Have elevations in
• • serum aspartate aminotransferase (AST) \>2.5× upper limit normal (ULN)
• • serum alanine aminotransferase (ALT) \>2.5×ULN
• • total bilirubin level (TBL) \>1.5×ULN, or
• • alkaline phosphatase (ALP) level ≥1.5× ULN.
• • Have a known clinically significant gastric emptying abnormality.