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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)

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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

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

Trial contacts and locations

45

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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