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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)

Diabetes Mellitus, Type 2

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation Criteria

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 Location

Aggarwal and Associates Limited
Aggarwal and Associates Limited
Brampton, Ontario
Canada

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Backup Contact

Naresh Aggarwal

Bluewater Clinical Research Group Inc.
Bluewater Clinical Research Group Inc.
Sarnia, Ontario
Canada

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Backup Contact

John O'Mahony

9109-0126 Quebec Inc.
9109-0126 Quebec Inc.
Montreal, Quebec
Canada

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Backup Contact

Ronald Akhras

Centricity Research Brampton Endocrinology
Centricity Research Brampton Endocrinology
Brampton, Ontario
Canada

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Backup Contact

Harpreet Bajaj

Hamilton Medical Research Group
Hamilton Medical Research Group
Hamilton, Ontario
Canada

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Backup Contact

Richard Tytus

Private Practice - Dr. Nigel Jagan
Private Practice - Dr. Nigel Jagan
Whitby, Ontario
Canada

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Backup Contact

Nigel Jagan

University of Calgary - Clinical Trials Unit
University of Calgary - Clinical Trials Unit
Calgary, Alberta
Canada

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Backup Contact

Ronald Sigal

Dr. Steven V. Zizzo Research Professional Corporation
Dr. Steven V. Zizzo Research Professional Corporation
Hamilton, Ontario
Canada

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Primary Contact

Steven Zizzo

Prime Health Clinical Research
Prime Health Clinical Research
Toronto, Ontario
Canada

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Backup Contact

Iris Shasha Gorfinkel

Alberta Diabetes Institute
Alberta Diabetes Institute
Edmonton, Alberta
Canada

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Primary Contact

Peter Senior

The Wharton Medical Clinic Clinical Trials Inc
The Wharton Medical Clinic Clinical Trials Inc
Hamilton, Ontario
Canada

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Backup Contact

Sean Wharton

Maple Leaf Research
Maple Leaf Research
Toronto, Ontario
Canada

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Backup Contact

Graham Smith

Study Sponsored By
Eli Lilly and Company
Participants Required
More Information
Study ID: NCT06260722