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Active, Not Recruiting

NCT Number: NCT06260722

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)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CARE - Centro de Alergia y Enfermedades Respiratorias, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

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 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.

Treatment and study plan

Retatrutide

Drug

Administered SC.

Other names: LY3437943

semaglutide

Drug

Administered SC.

Primary outcomes

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

    Time frame: Baseline, Week 80

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Randomized, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Semaglutide Once Weekly in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 15, 2024
Registry last updated
Apr 13, 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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