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OpenTrials
Active, Not Recruiting

NCT Number: NCT06297603

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)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retatrutide

Drug

Administered SC

Other names: LY3437943

Placebo

Drug

Administered SC

Primary outcomes

  1. Change from Baseline in Hemoglobin A1c (HbA1c) (%)

    Time frame: Baseline, Week 52

Secondary outcomes

  1. Percentage of Participants Achieving HbA1c <7.0%

    Time frame: Week 52

  2. Percentage of Participants Achieving HbA1c ≤6.5%

    Time frame: Week 52

  3. Change from Baseline in Fasting Serum Glucose

    Time frame: Baseline, Week 52

  4. Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL

    Time frame: Week 52

    Measured during the CGM session that occurs during 30 days prior to Week 52

  5. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 52

  6. Change from Baseline in Body Weight

    Time frame: Baseline, Week 52

  7. Percentage of Participants Achieving Weight Reduction of ≥5%

    Time frame: Week 52

  8. Percentage of Participants Achieving Weight Reduction of ≥10%

    Time frame: Week 52

  9. Percentage of Participants Achieving Weight Reduction of ≥15%

    Time frame: Week 52

  10. Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction

    Time frame: Week 52

  11. Percent Change from Baseline in Non-HDL Cholesterol

    Time frame: Baseline, Week 52

  12. Percent Change from Baseline in Triglycerides

    Time frame: Baseline, Week 52

  13. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline, Week 52

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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