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

Lilly

Status and phase: Not yet enrolling; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Retatrutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06982846

2024-518471-63-00 (EU Trial (CTIS) Number)

27316

J1I-MC-GZQF (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups, including a placebo group

Retatrutide

Experimental group

Description:

Participants will receive escalated doses of retatrutide administered subcutaneously (SC) every week (QW) until reaching target dose.

Treatment:

Drug: Retatrutide

Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo administered SC QW.

Treatment:

Drug: Placebo