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)

Purpose

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.

Condition

  • Diabetes Mellitus, Type 2

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Retatrutide Dose Level 1 		Participants will receive retatrutide administered subcutaneously (SC).
  • Drug: Retatrutide
    Administered SC.
    Other names:
    • LY3437943
Experimental
Retatrutide Dose Level 2 		Participants will receive retatrutide administered SC.
  • Drug: Retatrutide
    Administered SC.
    Other names:
    • LY3437943
Active Comparator
Semaglutide 		Participants will receive semaglutide administered SC.
  • Drug: Semaglutide
    Administered SC.

Recruiting Locations

MedStar Health Research Institute (MedStar Physician Based Research Network)
Hyattsville, Maryland 20782
Contact:
443-444-5663

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com