What this trial means for you
This study is active, not recruiting. It is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Retatrutide, Placebo for type 2 diabetes.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
The purpose of this study is to investigate the efficacy and safety of retatrutide compared with placebo in participants with Type 2 Diabetes and renal impairment, with inadequate glycemic control on basal insulin alone or a combination of basal insulin with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study will last about 14 months and may include up to 22 visits.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: * Have Type 2 Diabetes (T2D) * Have HbA1c ≥7.0% (53 millimoles per mole (mmol/mol)) to ≤10.5% (91 mmol/mol) * Have moderate or severe renal impairment * Have been on the following stable diabetes treatment during 90 days prior to screening * basal insulin (≥20 International Units (IU)/day) with or without * metformin and/or SGLT2 inhibitor * 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/m2) 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 a history of unstable or rapidly progressing renal disease * Have a prior or planned surgical treatment for obesity * Have New York Heart Association Functional Classification III or IV congestive heart failure * Have had 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 a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2. * Have any lifetime history of a suicide attempt * Had chronic or acute pancreatitis * Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening
Study sites by state
Alabama
- Nephrology Consultants, Huntsville
Arizona
- Clinical Research Institute of Arizona (CRI) - Sun City West, Sun City West
California
- Kidney & Hypertension Center - Apple Valley, Apple Valley
- Hope Clinical Research, Inc., Canoga Park
- Neighborhood Healthcare Institute of Health, Escondido
- EndoTrials Center for Clinical Research, La Mesa
- UCLA South Bay Endocrinology, Torrance
Florida
- Northeast Research Institute (NERI), Fleming Island
- Encore Medical Research - Weston, Weston
Georgia
- Orita Clinical Research, Decatur
Idaho
- CARE Institute, Idaho Falls
Kansas
- Cotton O'Neil Diabetes & Endocrinology, Topeka
Montana
- Billings Clinic, Billings
Nevada
- Excel Clinical Research, LLC, Las Vegas
New York
- Albany Medical College, Division of Community Endocrinology, Albany
- NYC Research INC, Long Island City
- Research Foundation of SUNY - University of Buffalo, Williamsville
North Carolina
- University of North Carolina Medical Center, Chapel Hill
Oklahoma
- Central States Research, Tulsa
Pennsylvania
- Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair, Pittsburgh
Tennessee
- AM Diabetes & Endocrinology Center, Bartlett
Texas
- Velocity Clinical Research, Dallas, Dallas
- Prime Revival Research Institute, LLC, Flower Mound
- Juno Research, Houston
- PlanIt Research, PLLC, Houston
- Southern Endocrinology Associates, Mesquite
- Texas Valley Clinical Research, Weslaco
Utah
- Diabetes & Endocrine Treatment Specialists, Sandy City
View the official record on ClinicalTrials.gov →
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