A Randomized, Placebo-Controlled, Parallel Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
The purpose of this study is to measure the effect of retatrutide versus placebo, administered every week, on time to recovery from hypoglycemia during hypoglycemic clamp in participants with Type 2 Diabetes Mellitus (T2DM) following 16 weeks of treatment.
• 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.