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Trial · Interventional

CompletedPhase 3Registry data

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)

NCTNCT06354660 (opens ClinicalTrials.gov in a new tab)Other id18804Other idJ1I-MC-GZBY

Overview

Status
Completed
Phase
Phase 3
Enrollment
537 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
4 countries

United States, India, Mexico, Puerto Rico

Start
10 Apr 2024
Primary completion
22 Jan 2026
Completion
20 Feb 2026
First posted
9 Apr 2024
Last update posted
5 Mar 2026
Conditions
Diabetes Type 2

Timeline

1 trial · 1 completed

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

    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)

    NCT06354660

    10 Apr 2024 to 20 Feb 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 inadequate glycemic control. The study will last about 11 months and may include up to 11 visits.

Interventions

  • RetatrutideDrug
  • PlaceboDrug

Arms4

  • Experimental

    Retatrutide Dose Level 1

    Participants will receive retatrutide administered subcutaneously (SC).

  • Experimental

    Retatrutide Dose Level 2

    Participants will receive retatrutide administered SC.

  • Experimental

    Retatrutide Dose Level 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 40

Secondary outcomes(13)
  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

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.

Completed trials do not always post results.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

10 results

Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial.

Bajaj et al. 2026Lancet (London, England)cited by 12

PMID 42250575DOI 10.1016/s0140-6736(26)00967-0PUB-42250575

Full text at the publisher10 results

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% 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.

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