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)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT06297603
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Retatrutide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Mar 15, 2024
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Retatrutide Dose 1
    Participants will receive retatrutide administered subcutaneously (SC).
  • Experimental: Retatrutide Dose 2
    Participants will receive retatrutide administered SC.
  • Experimental: Retatrutide Dose 3
    Participants will receive retatrutide administered SC.
  • Placebo Comparator: Placebo
    Participants will receive placebo administered SC.

Primary Outcome Measure

Change from Baseline in Hemoglobin A1c (HbA1c) (%) [ Time Frame: Baseline, Week 52 ]

Locations (28)

FacilityCityStateZIPSite coordinators
Nephrology ConsultantsHuntsvilleAlabama35805-
Clinical Research Institute of Arizona (CRI) - Sun City WestSun City WestArizona85375-
Kidney & Hypertension Center - Apple ValleyApple ValleyCalifornia92307-
Hope Clinical Research, Inc.Canoga ParkCalifornia91303-
Neighborhood Healthcare Institute of HealthEscondidoCalifornia92025-
EndoTrials Center for Clinical ResearchLa MesaCalifornia91942-
UCLA South Bay EndocrinologyTorranceCalifornia90505-
Northeast Research Institute (NERI)Fleming IslandFlorida32003-
Encore Medical Research - WestonWestonFlorida33331-
Orita Clinical ResearchDecaturGeorgia30034-
CARE InstituteIdaho FallsIdaho83404-
Cotton O'Neil Diabetes & EndocrinologyTopekaKansas66606-
Billings ClinicBillingsMontana59101-
Excel Clinical Research, LLCLas VegasNevada89109-
Albany Medical College, Division of Community EndocrinologyAlbanyNew York12203-
NYC Research INCLong Island CityNew York11106-
Research Foundation of SUNY - University of BuffaloWilliamsvilleNew York14221-
University of North Carolina Medical CenterChapel HillNorth Carolina27514-
Central States ResearchTulsaOklahoma74136-
Preferred Primary Care Physicians, Preferred Clinical Research-St. ClairPittsburghPennsylvania15243-
AM Diabetes & Endocrinology CenterBartlettTennessee38133-
Velocity Clinical Research, DallasDallasTexas75230-
Prime Revival Research Institute, LLCFlower MoundTexas75098-
Juno ResearchHoustonTexas77040-
PlanIt Research, PLLCHoustonTexas77079-
Southern Endocrinology AssociatesMesquiteTexas75149-
Texas Valley Clinical ResearchWeslacoTexas78596-
Diabetes & Endocrine Treatment SpecialistsSandy CityUtah84093-

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