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Trial · Interventional

Active, not recruitingPhase 3Registry data

Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

NCTNCT06260722 (opens ClinicalTrials.gov in a new tab)Other id18805Other idJ1I-MC-GZBZ

Overview

Status
Active, not recruiting
Phase
Phase 3
Enrollment
1,250 participants (estimated)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
5 countries

United States, Argentina, Canada, Mexico, Puerto Rico

Start
21 Feb 2024
Primary completion
27 Aug 2026
Completion
Feb 2027 (estimated)
First posted
15 Feb 2024
Last update posted
28 Sept 2026
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025202620272028
  1. Ph 3

    Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

    NCT06260722

    21 Feb 2024 to est. Feb 2027

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 semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits.

Interventions

  • RetatrutideDrug
  • SemaglutideDrug

Arms3

  • Experimental

    Retatrutide Dose Level 1

    Participants will receive retatrutide administered subcutaneously (SC).

  • Experimental

    Retatrutide Dose Level 2

    Participants will receive retatrutide administered SC.

  • Active comparator

    Semaglutide

    Participants will receive semaglutide administered SC.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline, Week 80

Secondary outcomes(12)
  1. Change from Baseline in HbA1c (%)

    Time frame · Baseline, Week 80

  2. Percentage of Participants Who Achieve HbA1c ≤ 6.5%

    Time frame · Week 80

  3. Percentage of Participants Who Achieve HbA1c < 5.7%

    Time frame · Week 80

  4. Percent Change from Baseline in Body Weight

    Time frame · Week 80

  5. Change from Baseline in Body Weight

    Time frame · Baseline, Week 80

  6. Percentage of Participants Who Achieve Weight Reduction of ≥ 5%

    Time frame · Week 80

  7. Percentage of Participants Who Achieve Weight Reduction of ≥ 10%

    Time frame · Week 80

  8. Percentage of Participants Who Achieve Weight Reduction of ≥ 15%

    Time frame · Week 80

  9. Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction

    Time frame · Week 80

  10. Percent Change from Baseline in Triglycerides

    Time frame · Week 80

  11. Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol

    Time frame · Week 80

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

    Time frame · Baseline, Week 80

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 been on a stable diabetes treatment consisting of metformin ≥ 1500 milligrams per day (mg/day) with or without SGLT2i during 90 days prior to screening * Are of stable weight for at least 90 days prior to screening * Have a Body Mass Index (BMI) ≥ 25.0 kilograms per meter squared (kg/m\^2) 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 an estimated glomerular filtration rate (eGFR) \<45 milliliters/minute/1.73 meter squared (mL/min/1.73 m\^2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification IV congestive heart failure * Have had an 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 any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2 * 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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