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)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Diabetes Type 2
Age
18+
Phase
PHASE3
Participants Needed
480
Est. Completion Date
Jul 31, 2026
Treatment Type
INTERVENTIONAL
Sponsor
Eli Lilly and Company
ClinicalTrials.gov NCT Identifier
NCT06354660
Study Number
J1I-MC-GZBY
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