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Completed

NCT Number: NCT06354660

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

All India Institute of Medical Sciences, Raipur, Chhattisgarh, India

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% to ≤ 9.5%
  • Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening
  • 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/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) <15 milliliters/minute/1.73 meter squared (mL/min/1.73 m^2) 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

Placebo

Drug

Administered SC.

Primary outcomes

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

    Time frame: Baseline, Week 40

Secondary outcomes

  1. Percentage of Participants Who Achieve HbA1c < 7.0%

    Time frame: Week 40

  2. Percentage of Participants Who Achieve HbA1c ≤ 6.5%

    Time frame: Week 40

  3. Percentage of Participants Who Achieve HbA1c < 5.7%

    Time frame: Week 40

  4. Change from Baseline in Fasting Serum Glucose

    Time frame: Baseline, Week 40

  5. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 40

  6. Change from Baseline in Body Weight

    Time frame: Baseline, Week 40

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

    Time frame: Week 40

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

    Time frame: Week 40

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

    Time frame: Week 40

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

    Time frame: Week 40

  11. Percent Change from Baseline in Triglycerides

    Time frame: Baseline, Week 40

  12. Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol

    Time frame: Baseline, Week 40

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

    Time frame: Baseline, Week 40

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 and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2024
Registry last updated
Mar 5, 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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