Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)

Type 2 Diabetes Clinical Trial

Official title:

A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes, Moderate or Severe Renal Impairment With Inadequate Glycemic Control on Basal Insulin With or Without Metformin and/or SGLT2 Inhibitor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297603
• Other study ID #: 18806
• Secondary ID: J1I-MC-GZQA
• Status: Recruiting
• Phase: Phase 3
• Start date: March 15, 2024
• Est. completion date: October 9, 2026

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: October 9, 2026
• Est. primary completion date: September 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Retatrutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Investigaciones Medicas Imoba Srl	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CEDIC	Caba	Buenos Aires
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Centro Médico Colón	Córdoba
Argentina	CIMeL Clinical Research	Lanus	Buenos Aires
Argentina	Centro de Investigaciones Médicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	DIM Clínica Privada	Ramos Mejía	Buenos Aires
Argentina	Instituto de Investigaciones Clinicas Rosario	Rosario	Santa Fe
Argentina	Instituto de Investigaciones Clinicas Zarate	Rosario	Santa Fe
Puerto Rico	Centro de Endocrinologia Alcantara Gonzalez	Bayamon
Puerto Rico	Private Practice - Dr. Paola Mansilla-Letelier	Guaynabo
Puerto Rico	Endocrinologist Metabolic Clinic & Research Institute	San Juan
United Kingdom	Panthera Biopartners - Glasgow	Glasgow	Scotland
United Kingdom	Panthera Biopartners - Preston	Preston	England
United Kingdom	Panthera Biopartners - Manchester	Rochdale	Manchester
United Kingdom	Lister Hospital	Stevenage	Hertfordshire
United States	Albany Medical College, Division of Community Endocrinology	Albany	New York
United States	AM Diabetes & Endocrinology Center	Bartlett	Tennessee
United States	Billings Clinic	Billings	Montana
United States	Research Foundation of SUNY - University of Buffalo	Buffalo	New York
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Northeast Research Institute (NERI)	Fleming Island	Florida
United States	Lucas Research, Inc.	Hickory	North Carolina
United States	Endocrine Ips, Pllc	Houston	Texas
United States	Juno Research	Houston	Texas
United States	Care Research	Idaho Falls	Idaho
United States	Diabetes and Endocrine Associates	La Mesa	California
United States	NYC Research INC	Long Island City	New York
United States	Southern Endocrinology Associates	Mesquite	Texas
United States	Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair	Pittsburgh	Pennsylvania
United States	Sierra Nevada Specialty Care	Reno	Nevada
United States	Diabetes & Endocrine Treatment Specialists	Sandy	Utah
United States	Clinical Research Institute of Arizona (CRI) - Sun City West	Sun City West	Arizona
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	UCLA South Bay Endocrinology	Torrance	California
United States	Central States Research	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Puerto Rico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c) (%)		Baseline, Week 52
Secondary	Percentage of Participants Achieving HbA1c <7.0%		Week 52
Secondary	Percentage of Participants Achieving HbA1c =6.5%		Week 52
Secondary	Change from Baseline in Fasting Serum Glucose		Baseline, Week 52
Secondary	Percentage of Time Continuous Glucose Monitoring (CGM) Glucose Values are Between 70 and 180 mg/dL	Measured during the CGM session that occurs during 30 days prior to Week 52	Week 52
Secondary	Percent Change from Baseline in Body Weight		Baseline, Week 52
Secondary	Change from Baseline in Body Weight		Baseline, Week 52
Secondary	Percentage of Participants Achieving Weight Reduction of =5%		Week 52
Secondary	Percentage of Participants Achieving Weight Reduction of =10%		Week 52
Secondary	Percentage of Participants Achieving Weight Reduction of =15%		Week 52
Secondary	Percentage of Participants Achieving HbA1c =6.5% and =10% Weight Reduction		Week 52
Secondary	Percent Change from Baseline in Non-HDL Cholesterol		Baseline, Week 52
Secondary	Percent Change from Baseline in Triglycerides		Baseline, Week 52
Secondary	Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 52

External Links

•   Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)