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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

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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.