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Trial · Interventional

Active, not recruitingPhase 3Registry data

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)

NCTNCT06297603 (opens ClinicalTrials.gov in a new tab)Other id18806Other idJ1I-MC-GZQA

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
320 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
7 countries

United States, Argentina, Brazil, Israel, Mexico, Puerto Rico, United Kingdom

Start
15 Mar 2024
Primary completion
Oct 2026 (estimated)
Completion
Nov 2026 (estimated)
First posted
7 Mar 2024
Last update posted
20 Jul 2026
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 3

    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)

    NCT06297603

    15 Mar 2024 to est. Nov 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RetatrutideDrug
  • PlaceboDrug

Arms4

  • Experimental

    Retatrutide Dose 1

    Participants will receive retatrutide administered subcutaneously (SC).

  • Experimental

    Retatrutide Dose 2

    Participants will receive retatrutide administered SC.

  • Experimental

    Retatrutide Dose 3

    Participants will receive retatrutide administered SC.

  • Placebo comparator

    Placebo

    Participants will receive placebo administered SC.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline, Week 52

Secondary outcomes(13)
  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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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