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Investigating retatrutide for Type 2 Diabetes with kidney issues

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

Phase 3 Interventional Eli Lilly and Company · NCT06297603

This study tests if a new medication called retatrutide can help people with Type 2 Diabetes and kidney problems better control their blood sugar compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment320 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations80 sites (Huntsville, Alabama and 79 other locations)
Trial IDNCT06297603 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of retatrutide compared to a placebo in individuals with Type 2 Diabetes who also have moderate or severe renal impairment and are not achieving adequate glycemic control on basal insulin, with or without additional medications like metformin or SGLT2 inhibitors. The trial will last approximately 14 months and may involve up to 22 visits for participants. It focuses on patients who have been on stable diabetes treatment prior to screening and have specific HbA1c levels.

Who should consider this trial

Good fit: Ideal candidates are adults with Type 2 Diabetes, moderate to severe renal impairment, and inadequate glycemic control on their current diabetes regimen.

Not a fit: Patients with Type 1 Diabetes or those with a history of severe hypoglycemia or unstable renal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve glycemic control in patients with Type 2 Diabetes and renal impairment.

How similar studies have performed: Other studies have shown promise in treating Type 2 Diabetes with similar approaches, but this specific combination is being explored for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Huntsville, Alabama and 79 other locations

+30 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type 2 DiabetesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesDiabetes MellitusDiabetes Mellitus, Type 2Kidney DiseaseRenal Insufficiency Chronic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.