Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Retatrutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06297603

J1I-MC-GZQA (Other Identifier)

18806

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Type 2 Diabetes (T2D)

• Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol)

• Have moderate or severe renal impairment

• Have been on the following stable diabetes treatment during 90 days prior to screening

  • basal insulin (≥20 International Units (IU)/day) with or without
  • metformin and/or SGLT2 inhibitor

• Are of stable weight for at least 90 days prior to screening

• Have a Body Mass Index (BMI) ≥23.0 kilograms per meter squared (kg/m2)

Exclusion criteria

• Have Type 1 Diabetes (T1D)
• Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening
• Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
• Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
• Have a history of unstable or rapidly progressing renal disease
• Have a prior or planned surgical treatment for obesity
• Have New York Heart Association Functional Classification III or IV congestive heart failure
• Have had acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening
• Have a known clinically significant gastric emptying abnormality
• Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
• Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.
• Have any lifetime history of a suicide attempt
• Had chronic or acute pancreatitis
• Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 4 patient groups, including a placebo group

Retatrutide Dose 1

Experimental group

Description:

Participants will receive retatrutide administered subcutaneously (SC).

Treatment:

Drug: Retatrutide

Retatrutide Dose 2

Experimental group

Description:

Participants will receive retatrutide administered SC.

Treatment:

Drug: Retatrutide

Retatrutide Dose 3

Experimental group

Description:

Participants will receive retatrutide administered SC.

Treatment:

Drug: Retatrutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo administered SC.

Treatment:

Drug: Placebo