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AzTrials

Type 2 DiabetesPhase 3NCT06297603

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)

A Phase 3 study testing Retatrutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 76 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Retatrutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
76 sitesin 7 countries
Study dates
15 Mar 2024to Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

76 sites in 7 countries.

76 sites in 7 countries

United States28 sites

  • Albany Medical College, Division of Community Endocrinology

    Albany, New York, 12203

  • Kidney & Hypertension Center - Apple Valley

    Apple Valley, California, 92307

  • AM Diabetes & Endocrinology Center

    Bartlett, Tennessee, 38133

  • Billings Clinic

    Billings, Montana, 59101

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Orita Clinical Research

    Decatur, Georgia, 30034

  • Neighborhood Healthcare Institute of Health

    Escondido, California, 92025

  • Northeast Research Institute (NERI)

    Fleming Island, Florida, 32003

  • Prime Revival Research Institute, LLC

    Flower Mound, Texas, 75098

  • Juno Research

    Houston, Texas, 77040

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Nephrology Consultants

    Huntsville, Alabama, 35805

  • CARE Institute

    Idaho Falls, Idaho, 83404

  • EndoTrials Center for Clinical Research

    La Mesa, California, 91942

  • Excel Clinical Research, LLC

    Las Vegas, Nevada, 89109

  • NYC Research INC

    Long Island City, New York, 11106

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

    Pittsburgh, Pennsylvania, 15243

  • Diabetes & Endocrine Treatment Specialists

    Sandy City, Utah, 84093

  • Clinical Research Institute of Arizona (CRI) - Sun City West

    Sun City West, Arizona, 85375

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

  • UCLA South Bay Endocrinology

    Torrance, California, 90505

  • Central States Research

    Tulsa, Oklahoma, 74136

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596

  • Encore Medical Research - Weston

    Weston, Florida, 33331

  • Research Foundation of SUNY - University of Buffalo

    Williamsville, New York, 14221

Other trials in United States

Argentina18 sites

  • Investigaciones Medicas Imoba Srl

    Buenos Aires, C1056ABH

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

  • CIPREC

    Buenos Aires, C1061AAS

  • CIPREC

    Buenos Aires, C1119ACN

  • Centro Médico Viamonte

    Buenos Aires, C1120AAC

  • Mautalen Salud e Investigación

    Buenos Aires, C1128AAF

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425AGC

  • CEDIC

    CABA, C1060ABN

  • Centro Diabetológico Dr. Waitman

    Córdoba, 5000

  • Centro Médico Colón

    Córdoba, X5003DCP

  • Centro de Investigaciones Clínicas Baigorria

    Granadero Baigorria, 2152

  • CIMeL

    Lanus, B1824KAJ

  • Centro de Investigaciones Médicas Mar del Plata

    Mar del Plata, 7600

  • DIM Clínica Privada

    Ramos Mejía, B1704ETD

  • INECO Neurociencias Oroño

    Rosario, 2000

  • Instituto Médico Catamarca IMEC

    Rosario, 2000

  • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica

    Rosario, 2000

  • Instituto de Investigaciones Clinicas Rosario

    Rosario, S2000CVD

Other trials in Argentina

United Kingdom9 sites

  • Southmead Hospital

    Bristol, BS10 5NB

  • Edinburgh Royal Infirmary

    Edinburgh, EH16 4SA

  • Panthera Biopartners - Glasgow

    Glasgow, G51 4LB

  • George Eliot Hospital

    Nuneaton, CV10 7DJ

  • Panthera Biopartners - Preston

    Preston, PR2 9QB

  • Panthera Biopartners - Manchester

    Rochdale, OL11 4AU

  • Salford Royal Hospital

    Salford, M6 8HD

  • Lister Hospital

    Stevenage, SG1 4AB

  • The Royal Cornwall Hospital

    Truro, TR1 3LJ

Other trials in United Kingdom

Brazil7 sites

  • Centro de Diabetes Curitiba

    Curitiba, 80810-040

  • Instituto de Ensino e Pesquisa Clinica do Ceara

    Fortaleza, 60125058

  • Centro de Pesquisas Clínicas Dr. Marco Mota

    Maceió, 57051-160

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180

  • Praxis Pesquisa Medica

    Santo André, 09790790

  • Instituto de Pesquisa Clinica

    São Paulo, 01223-001

  • CEDOES

    Vitória, 29055450

Other trials in Brazil

Israel7 sites

  • Clalit Health Services - Atlit

    Atlit, 3032301

  • Soroka Medical Center

    Beersheba, 8410101

  • Institute of Diabetes, Technology and Research - Clalit Health

    Herzliya, 4630945

  • Edith Wolfson Medical Center

    Holon, 5810001

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Sheba Medical Center

    Ramat Gan, 5262100

  • Clalit Health Services - Sakhnin Community Clinic

    Sakhnin, 3081000

Other trials in Israel

Mexico4 sites

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua City, 31110

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, 44130

  • Medical Care and Research SA de CV

    Mérida, 97070

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900

Other trials in Mexico

Puerto Rico3 sites

  • Centro de Endocrinologia Alcantara Gonzalez

    Bayamón, 00956

  • Isis Clinical Research Center

    Guaynabo, 00968

  • Mgcendo Llc

    San Juan, 00921

Other trials in Puerto Rico

About this study

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

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.

Conditions
Type 2 Diabetes
Being tested
Retatrutide, Placebo
Keywords
Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2, Kidney Disease, Renal Insufficiency Chronic
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus, Kidney Diseases, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetatrutideDrug

    Also called LY3437943

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT06297603
Study groupRoleWhat they receive
Retatrutide Dose 1ExperimentalParticipants will receive retatrutide administered subcutaneously (SC).
Receives: Drug: Retatrutide
Retatrutide Dose 2ExperimentalParticipants will receive retatrutide administered SC.
Receives: Drug: Retatrutide
Retatrutide Dose 3ExperimentalParticipants will receive retatrutide administered SC.
Receives: Drug: Retatrutide
PlaceboPlacebo comparatorParticipants will receive placebo administered SC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Hemoglobin A1c (HbA1c) (%)

    Measured: Baseline, Week 52

Secondary outcomes (13)

  1. Percentage of Participants Achieving HbA1c <7.0%

    Measured: Week 52

  2. Percentage of Participants Achieving HbA1c ≤6.5%

    Measured: Week 52

  3. Change from Baseline in Fasting Serum Glucose

    Measured: Baseline, Week 52

  4. 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

    Measured: Week 52

  5. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 52

  6. Change from Baseline in Body Weight

    Measured: Baseline, Week 52

  7. Percentage of Participants Achieving Weight Reduction of ≥5%

    Measured: Week 52

  8. Percentage of Participants Achieving Weight Reduction of ≥10%

    Measured: Week 52

  9. Percentage of Participants Achieving Weight Reduction of ≥15%

    Measured: Week 52

  10. Percentage of Participants Achieving HbA1c ≤6.5% and ≥10% Weight Reduction

    Measured: Week 52

  11. Percent Change from Baseline in Non-HDL Cholesterol

    Measured: Baseline, Week 52

  12. Percent Change from Baseline in Triglycerides

    Measured: Baseline, Week 52

  13. Change from Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2024
  2. Study start15 Mar 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06297603
Sponsor's protocol ID
18806
Other IDs
J1I-MC-GZQA
Status last verified
Jul 2026
First submitted
1 Mar 2024
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retatrutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 76 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Argentina, United Kingdom, Brazil, Israel and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Hemoglobin A1c (HbA1c) (%) (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06297603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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